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List of Excipients in Branded Drug GOOD SENSE ALL DAY PAIN RELIEF
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Generic Drugs Containing GOOD SENSE ALL DAY PAIN RELIEF
| Company | Ingredient | NDC | Excipient |
|---|---|---|---|
| Aidarex Pharmaceuticals LLC | naproxen sodium | 33261-079 | CELLULOSE, MICROCRYSTALLINE |
| Aidarex Pharmaceuticals LLC | naproxen sodium | 33261-079 | HYPROMELLOSES |
| Aidarex Pharmaceuticals LLC | naproxen sodium | 33261-079 | MAGNESIUM STEARATE |
| Aidarex Pharmaceuticals LLC | naproxen sodium | 33261-079 | POLYETHYLENE GLYCOLS |
| >Company | >Ingredient | >NDC | >Excipient |
What are the Most Frequently-Used Excipients in GOOD SENSE ALL DAY PAIN RELIEF?
| # Of NDCs | Excipient |
|---|---|
| 3 | CELLULOSE, MICROCRYSTALLINE |
| 1 | FD&C BLUE NO. 2 |
| 3 | HYPROMELLOSES |
| 3 | MAGNESIUM STEARATE |
| ># Of NDCs | >Excipient |
Good Sense All Day Pain Relief: Excipient Strategy and Commercial Opportunities
Good Sense All Day Pain Relief is an over-the-counter extended-release acetaminophen product, typically marketed as a 650 mg caplet for temporary relief of minor aches, pains, and fever. Its commercial position depends less on active-ingredient differentiation than on manufacturing cost, release consistency, tablet swallowability, label compliance, retailer economics, and supply reliability.
The strongest formulation opportunities are a robust hydrophilic-matrix or coated-tablet system, low-cost excipient sourcing, improved caplet ergonomics, and packaging that supports adherence while reducing overdose risk. Because acetaminophen is an established OTC monograph ingredient, the product has limited conventional patent protection and faces immediate competition from Tylenol 8 HR and other store-brand extended-release acetaminophen products.
What is Good Sense All Day Pain Relief?
Good Sense All Day Pain Relief is an OTC acetaminophen extended-release analgesic and antipyretic. Public product labeling identifies the product category as acetaminophen extended-release caplets, generally containing 650 mg acetaminophen per caplet.[1]
| Attribute | Product position |
|---|---|
| Active ingredient | Acetaminophen |
| Typical strength | 650 mg extended-release caplet |
| Dosage form | Caplet or tablet |
| Regulatory category | OTC analgesic and antipyretic |
| Primary use | Temporary relief of minor aches, pains, and fever |
| Reference competitor | Tylenol 8 HR Arthritis Pain |
| Commercial class | Store-brand or private-label equivalent |
| Prescription status | Nonprescription |
| Orange Book status | Generally not applicable to an OTC monograph product |
| Primary differentiation | Price, duration, retailer placement, packaging, and tolerability |
The product competes in a mature category. A formulation owner cannot rely on acetaminophen itself to create meaningful exclusivity. Commercial value comes from manufacturing efficiency and product presentation.
What excipients are used in Good Sense All Day Pain Relief?
The likely excipient system for an acetaminophen extended-release caplet includes a release-controlling polymer, tablet binders, disintegrants, lubricants, glidants, pigments, and film-coating materials. The exact inactive-ingredient list is NDC-specific and should be taken from the applicable DailyMed label and approved manufacturer documentation.[1]
Core excipient functions
| Excipient class | Typical candidates | Commercial and technical function |
|---|---|---|
| Release controller | Hypromellose | Controls water penetration and acetaminophen diffusion |
| Binder | Povidone, pregelatinized starch, cellulose derivatives | Provides tablet strength and granulation integrity |
| Diluent | Microcrystalline cellulose, starch | Adjusts tablet weight and compression properties |
| Disintegrant | Sodium starch glycolate or related material | Supports residual tablet breakup after release |
| Lubricant | Magnesium stearate | Reduces sticking and ejection force |
| Glidant | Colloidal silicon dioxide | Improves powder flow and die filling |
| Coating | Hypromellose, cellulose-based film, polyethylene glycol | Improves swallowability, appearance, and handling |
| Opacifier or colorant | Titanium dioxide or approved colorants | Controls appearance and product identification |
| Surface wax | Carnauba wax in some products | Improves gloss and reduces moisture interaction |
The principal technical issue is balancing sustained release against acceptable dose uniformity. Acetaminophen is a high-dose active ingredient relative to many branded oral drugs. Excipients therefore must control release without producing an excessively large caplet.
How does the excipient strategy control extended release?
A hydrophilic-matrix design is the most commercially practical strategy for a 650 mg acetaminophen caplet. Hypromellose hydrates on contact with gastrointestinal fluid and forms a gel layer. The gel slows liquid penetration and active-ingredient diffusion.
A typical development strategy would control:
- Polymer viscosity grade.
- Polymer concentration.
- Acetaminophen particle-size distribution.
- Granulation endpoint.
- Compression force and tablet porosity.
- Coating thickness.
- Dissolution performance across pH conditions.
A higher-viscosity hypromellose grade can reduce release rate but may increase tablet size, compression sensitivity, and batch-to-batch variability. A lower-viscosity grade can improve processing but may release acetaminophen too quickly.
A multiparticulate or coated-particle system could provide finer release control, but it would usually increase manufacturing cost. For a private-label analgesic, that cost is difficult to justify unless it improves product performance, enables a meaningful label claim, or supports a differentiated dosage form.
What formulation opportunities exist for Good Sense All Day Pain Relief?
Smaller or easier-to-swallow caplets
The 650 mg acetaminophen load creates a physical size constraint. Opportunities include:
- Higher-density granulation.
- Improved particle packing.
- Reduced coating weight.
- More efficient polymer placement.
- Caplet geometry optimization.
- Rounded edges and lower tablet thickness.
A smaller caplet could support premium store-brand positioning, but the design must preserve dissolution performance and mechanical strength.
Lower-cost excipient substitution
Potential cost reductions include replacing specialty grades with qualified pharmaceutical-grade alternatives, reducing coating weight, and using a common excipient platform across multiple retailer products.
Substitution requires comparative evaluation of:
- Dissolution profiles.
- Hardness and friability.
- Content uniformity.
- Stability.
- Lubrication sensitivity.
- Scale-up performance.
- Supplier change-control burden.
The economic benefit is strongest when the same excipient system can support multiple acetaminophen strengths, ibuprofen products, aspirin products, or combination analgesics.
Reduced allergen and intolerance profile
A formulation can be positioned around the absence of selected ingredients such as lactose, gluten-containing excipients, artificial dyes, or animal-derived materials, provided the claims are supported by supplier documentation and applicable labeling requirements.
This approach is more commercially credible in a retailer-owned product portfolio than in a single low-price SKU. A retailer can apply the same excipient policy across pain, cold, allergy, and gastrointestinal products.
Improved moisture protection
Acetaminophen tablets are generally stable, but moisture can affect coating integrity, tablet hardness, dissolution, and appearance. Opportunities include:
- Moisture-resistant film coatings.
- High-barrier blister packaging.
- Desiccant-enabled bottles.
- Induction seals.
- Low-moisture secondary packaging.
Packaging changes may provide greater stability benefit than adding complex excipients to the tablet.
What FDA regulatory status applies to Good Sense All Day Pain Relief?
Acetaminophen oral analgesic products are regulated under the FDA OTC monograph framework for internal analgesic, antipyretic, and antirheumatic products, subject to applicable conditions in 21 CFR Part 343 and related FDA requirements.[2]
| Regulatory issue | Assessment |
|---|---|
| FDA pathway | OTC monograph or applicable OTC order pathway |
| Prescription approval | Not required for a compliant monograph product |
| NDA exclusivity | Generally not applicable |
| ANDA pathway | Generally not the primary route for an OTC monograph product |
| Acetaminophen labeling | Subject to FDA dosage, warning, and liver-risk requirements |
| Product-specific exclusivity | No conventional new-drug exclusivity expected |
| Pediatric positioning | Must follow applicable labeling and dosage requirements |
| Combination products | Require separate evaluation of active ingredients and labeling |
The FDA has emphasized the risk of severe liver damage from excessive acetaminophen exposure and from simultaneous use of multiple acetaminophen-containing products.[3] Label design and package architecture are therefore part of the product’s risk-management strategy.
What patents protect Good Sense All Day Pain Relief?
No meaningful composition-of-matter patent protection should be expected for acetaminophen. The active ingredient has been marketed for decades, and the core drug substance is in the public domain.
Potential intellectual-property categories include:
| IP category | Relevance |
|---|---|
| Acetaminophen composition patent | No meaningful current protection expected |
| Extended-release matrix patent | Older technology may exist, but broad foundational claims are likely expired |
| Coated-particle technology | May be relevant if a specific supplier system is used |
| Manufacturing process | Possible protection for granulation, coating, or compression parameters |
| Tablet design | Possible design or trade-dress protection |
| Packaging | Child-resistant, unit-dose, or adherence-oriented designs may be protectable |
| Trademark | Good Sense and related retailer branding |
| Trade secret | Process controls, supplier specifications, and dissolution targets |
Patent risk is therefore more likely to arise from a third-party controlled-release platform, coated-particle technology, or manufacturing process than from acetaminophen itself.
When does Good Sense All Day Pain Relief lose exclusivity?
Good Sense All Day Pain Relief has no conventional prescription-drug exclusivity period to expire. OTC private-label competition is generally available once a manufacturer can produce a compliant acetaminophen extended-release product and obtain the required FDA marketing authorization or monograph compliance.
The practical exclusivity timeline is:
| Milestone | Commercial effect |
|---|---|
| Active ingredient enters public domain | Eliminates drug-substance exclusivity |
| OTC monograph pathway becomes available | Enables multiple manufacturers |
| Retailer private-label launch | Establishes price competition |
| Supplier qualification | Creates temporary operational advantage |
| Retailer contract award | Provides commercial access but not statutory exclusivity |
| Process optimization | Improves margin and supply reliability |
Are there Paragraph IV challenges to Good Sense All Day Pain Relief?
Paragraph IV litigation is generally associated with abbreviated new drug applications for listed prescription drugs. It is not the normal competitive mechanism for an OTC acetaminophen monograph product.
The relevant competitive risks are instead:
- Competing OTC monograph products.
- Private-label supplier switching.
- Retailer dual sourcing.
- Contract-manufacturer competition.
- FDA labeling enforcement.
- Trademark disputes.
- Trade-secret or manufacturing-process disputes.
- Potential disputes over controlled-release technology.
No product-specific Paragraph IV challenge should be assumed for Good Sense All Day Pain Relief absent a prescription-listed product and an identified abbreviated application.
What is the Orange Book status of Good Sense All Day Pain Relief?
The Orange Book is primarily a listing of approved drug products, therapeutic equivalence evaluations, and patent or exclusivity information for approved prescription and certain other applications.[4] A store-brand OTC monograph acetaminophen product is not expected to have the same Orange Book patent-listing profile as an NDA product such as a prescription extended-release drug.
The absence of an Orange Book listing does not remove all IP risk. It means the commercial analysis should focus on:
- FDA OTC compliance.
- Label accuracy.
- Manufacturing controls.
- Supplier agreements.
- Trademark rights.
- Process and formulation patents held by excipient or technology suppliers.
How strong is the patent estate for Good Sense All Day Pain Relief?
The product-level patent estate is weak. The strongest defensible assets are likely operational rather than molecule-based.
| Asset | Relative strength | Reason |
|---|---|---|
| Acetaminophen molecule | Low | Long-established active ingredient |
| Generic extended-release concept | Low to moderate | Broad claims may be old or expired |
| Specific polymer ratio and process | Moderate | Narrow claims may survive depending on ownership and dates |
| Coated-particle manufacturing | Moderate | Can create technical differentiation |
| Tablet geometry | Low to moderate | Narrow scope and easy design-around |
| Packaging system | Moderate | May protect a specific child-resistant or unit-dose design |
| Supplier qualification network | High operational value | Difficult to replicate quickly but not a patent monopoly |
| Retailer placement | High commercial value | Drives volume but is contract-dependent |
A freedom-to-operate review should examine active patents covering acetaminophen extended-release formulations, coated particles, matrix tablets, compression processes, and packaging. The key question is whether a proposed formulation uses a licensed technology platform.
What manufacturing barriers affect commercial opportunities?
Manufacturing is the main barrier to a profitable private-label product. Acetaminophen is inexpensive, but extended-release performance can be sensitive to process variation.
Important control points include:
- Active-ingredient particle size.
- Blend uniformity at high drug loading.
- Granule density.
- Polymer distribution.
- Compression force.
- Tablet porosity.
- Coating uniformity.
- Dissolution after accelerated stability.
- Packaging moisture ingress.
- Equipment cleaning and cross-contamination controls.
A manufacturer with existing high-speed tablet presses, film coaters, and validated dissolution methods has a cost advantage. A new entrant may need to outsource production to a contract development and manufacturing organization, reducing capital requirements but increasing supplier dependence.
Which companies challenge Good Sense All Day Pain Relief?
The principal competitors are branded and private-label acetaminophen products rather than innovative prescription drugs.
| Competitor group | Examples | Competitive basis |
|---|---|---|
| Branded extended-release acetaminophen | Tylenol 8 HR Arthritis Pain | Brand recognition, distribution, trust |
| Retail private labels | CVS, Walgreens, Walmart, Target, Amazon and regional brands | Price and retailer control |
| Standard-release acetaminophen | Multiple generic manufacturers | Lower price and broader availability |
| Combination analgesics | Products containing acetaminophen with other actives | Symptom-specific positioning |
| Alternative OTC analgesics | Ibuprofen and naproxen products | Different duration and consumer preference |
A private-label extended-release acetaminophen product is most competitive where the retailer controls shelf placement, digital search ranking, and replenishment.
What licensing deals affect Good Sense All Day Pain Relief?
The active ingredient does not require a license. A license may be necessary for:
- A proprietary controlled-release polymer system.
- Coated acetaminophen particles.
- A patented manufacturing process.
- A specialized coating or barrier technology.
- Child-resistant or unit-dose packaging.
- A third-party brand or co-branding arrangement.
For a low-price OTC product, licensing economics must be tightly controlled. A royalty-bearing technology is attractive only if it reduces manufacturing cost, improves regulatory performance, creates a defensible claim, or materially increases retailer demand.
What commercial opportunities exist for excipient suppliers?
Excipient suppliers can capture value by offering validated formulation platforms rather than commodity materials. The strongest opportunities include:
- A ready-to-use extended-release matrix system for high-dose acetaminophen.
- A low-moisture formulation and packaging package.
- A smaller-caplet platform with preserved dissolution performance.
- A dye-free or animal-origin-free excipient system.
- A multi-product platform covering acetaminophen, ibuprofen, and combination analgesics.
- Technical support for scale-up, dissolution modeling, and post-approval change management.
The commercial buyer is likely to value total cost per sellable unit, not the price of an individual excipient. Supplier proposals should quantify yield, compression speed, coating time, rejected-tablet rate, stability performance, and change-control requirements.
What generic launch scenarios exist?
Low-cost private-label launch
The manufacturer uses a conventional hydrophilic matrix, standard bottle packaging, and an established OTC label. This is the fastest and lowest-risk route but produces limited differentiation.
Premium store-brand launch
The product uses a smaller caplet, improved coating, dye-free excipients, and higher-barrier packaging. The retailer can support a modest price premium.
Multi-SKU platform launch
The same excipient and manufacturing platform supports extended-release acetaminophen, standard-release acetaminophen, and other analgesic products. This approach improves procurement leverage and manufacturing utilization.
Unit-dose or travel package
Blister or sachet packaging can target travel, workplace, institutional, and e-commerce channels. Packaging costs rise, but dose visibility and portability improve.
How does Good Sense compare with Tylenol 8 HR?
| Factor | Good Sense All Day Pain Relief | Tylenol 8 HR |
|---|---|---|
| Active ingredient | Acetaminophen | Acetaminophen |
| Typical strength | 650 mg extended release | 650 mg extended release |
| Brand equity | Lower | Higher |
| Price | Generally lower | Generally higher |
| Patent advantage | Limited | Product-specific legacy IP may be relevant, but broad acetaminophen protection is not expected |
| Retailer control | Potentially high for private label | Brand-led |
| Formulation differentiation | Limited public differentiation | Brand and packaging differentiation |
| Main purchase driver | Value | Trust, recognition, and availability |
The private-label product can win on price and retailer placement. The branded product retains advantages in consumer recognition and physician or pharmacist familiarity.
Key Takeaways
- Good Sense All Day Pain Relief is an OTC extended-release acetaminophen product, generally positioned around a 650 mg caplet.
- Its commercial value is driven by cost, release consistency, packaging, and retailer distribution rather than active-ingredient exclusivity.
- Hypromellose-based matrix technology is the most practical excipient strategy for a low-cost extended-release caplet.
- The main formulation opportunities are smaller caplets, improved coating, moisture protection, dye-free positioning, and multi-SKU platform development.
- No conventional Orange Book exclusivity or Paragraph IV pathway should be assumed for this OTC monograph product.
- The product-level patent estate is likely weak; third-party controlled-release, coating, process, and packaging rights remain the main freedom-to-operate issues.
- Excipient suppliers can create value through validated platform systems and manufacturing support, not commodity material supply alone.
- Product-specific revenue, NDC, manufacturer, and exact inactive-ingredient conclusions require identification of the applicable marketed label.
FAQs
Is Good Sense All Day Pain Relief the same as Tylenol 8 HR?
Both products are generally positioned as 650 mg extended-release acetaminophen caplets, but their inactive ingredients, tablet dimensions, release profile, manufacturer, labeling, and packaging can differ.
Can a manufacturer reformulate the excipients without filing a new drug application?
An OTC manufacturer may make changes within the applicable FDA regulatory framework, but the change must preserve product quality, dissolution, stability, labeling compliance, and manufacturing controls. A significant formulation change may require regulatory review.
Which excipient is most important for extended-release acetaminophen?
The release-controlling polymer, commonly hypromellose in matrix systems, usually has the greatest effect on dissolution. Particle size, granulation, compression, and coating also materially affect release.
Is a 650 mg acetaminophen extended-release tablet patentable?
A narrow formulation or manufacturing improvement may be patentable if it is novel and nonobvious. The acetaminophen active ingredient and broad extended-release concept do not provide reliable current exclusivity by themselves.
What is the best commercial differentiation for a private-label acetaminophen product?
The strongest options are lower price, easier swallowing, transparent dosing, high-visibility packaging, reliable extended-release performance, and a retailer-wide excipient or ingredient policy.
References
-
National Library of Medicine. (n.d.). DailyMed: Drug labels for acetaminophen extended-release tablets and caplets. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/
-
U.S. Food and Drug Administration. (2024). 21 CFR Part 343: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-343
-
U.S. Food and Drug Administration. (2023). Acetaminophen: Avoiding liver injury. https://www.fda.gov/drugs/information-drug-class/acetaminophen
-
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
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