List of Excipients in Branded Drug GOOD SENSE ANTI DIARRHEAL

« Back to Dashboard

Generic Drugs Containing GOOD SENSE ANTI DIARRHEAL

Company	Ingredient	NDC	Excipient
L Perrigo Company	loperamide hydrochloride	0113-0224	ANHYDROUS LACTOSE
L Perrigo Company	loperamide hydrochloride	0113-0224	CARNAUBA WAX
L Perrigo Company	loperamide hydrochloride	0113-0224	CELLULOSE, MICROCRYSTALLINE
L Perrigo Company	loperamide hydrochloride	0113-0224	D&C YELLOW NO. 10

What are the Most Frequently-Used Excipients in GOOD SENSE ANTI DIARRHEAL?

# Of NDCs	Excipient
4	ANHYDROUS LACTOSE
4	CARNAUBA WAX
4	CELLULOSE, MICROCRYSTALLINE
4	D&C YELLOW NO. 10

GoodSense Anti-Diarrheal Excipient Strategy and Commercial Opportunities

Last updated: October 21, 2026

GoodSense Anti-Diarrheal is an OTC loperamide hydrochloride product, generally marketed as a 2 mg oral solid dosage form. Its commercial opportunity is based on low-cost, reliable immediate-release manufacturing rather than active-ingredient exclusivity. The strongest formulation opportunities are rapid disintegration, tablet robustness, color-free and allergen-conscious excipient systems, unit-dose packaging, and differentiated versions such as chewable or orally disintegrating products. Loperamide is subject to FDA OTC requirements, and GoodSense does not have the patent-based market protection associated with a newly approved prescription drug. [1][2]

What is GoodSense Anti-Diarrheal?

GoodSense Anti-Diarrheal contains loperamide hydrochloride, an antidiarrheal agent used to control symptoms of acute nonspecific diarrhea and travelers' diarrhea. The standard OTC strength is 2 mg per tablet or capsule. Loperamide reduces intestinal motility and increases fluid absorption through peripheral opioid-receptor activity in the gastrointestinal tract. [1][3]

Product attribute	GoodSense Anti-Diarrheal
Active ingredient	Loperamide hydrochloride
Typical strength	2 mg
Dosage form	Immediate-release oral solid
Therapeutic category	OTC antidiarrheal
Primary use	Symptomatic control of diarrhea
Regulatory pathway	FDA OTC monograph pathway
Orange Book status	Generally not an Orange Book-listed OTC monograph product
Biosimilar exposure	None
Principal commercial competitors	Imodium A-D, store-brand loperamide products
Core formulation objective	Low-cost, stable, rapidly disintegrating oral dosage form

The exact GoodSense product label, inactive ingredients, manufacturer, and National Drug Code should be verified against the current DailyMed record because private-label products can change suppliers and formulations over time. [4]

What excipients are likely used in GoodSense Anti-Diarrheal?

Public product labels for generic loperamide tablets commonly use a conventional immediate-release excipient platform. The precise GoodSense formulation should not be inferred solely from another loperamide product because excipient systems can vary by contract manufacturer.

Typical excipient functions include:

Function	Common excipient options	Commercial purpose
Diluent and compression aid	Microcrystalline cellulose, lactose, dicalcium phosphate	Controls tablet weight and improves manufacturability
Binder	Povidone, pregelatinized starch, hydroxypropyl cellulose	Improves granule and tablet strength
Disintegrant	Croscarmellose sodium, crospovidone, sodium starch glycolate	Promotes rapid tablet breakup
Lubricant	Magnesium stearate, sodium stearyl fumarate	Reduces tooling friction and ejection force
Glidant	Colloidal silicon dioxide	Improves powder flow
Coating	Hypromellose, polyethylene glycol, talc, pigments	Improves appearance, handling, and swallowability
Colorant	Approved synthetic or mineral colorants	Supports product identification
Anti-adherent	Talc or silica-based systems	Reduces sticking during compression

For a high-volume store-brand product, the excipient strategy should minimize the number of ingredients while maintaining tablet hardness, friability, dissolution, and manufacturing yield. The lowest-cost formulation is not necessarily the most commercially attractive if it produces capping, sticking, slow disintegration, or variable dissolution.

Which excipient strategy is best for a loperamide immediate-release tablet?

A direct-compression or dry-granulation platform is usually commercially attractive because loperamide products require a low dose of active ingredient relative to tablet mass. The formulation must distribute the 2 mg dose uniformly across the blend.

A practical formulation strategy has four priorities:

1. Use a robust diluent system with consistent flow and content uniformity.
2. Include a high-performance superdisintegrant at a level sufficient to support rapid tablet breakup.
3. Control lubricant concentration and mixing time to avoid delayed dissolution.
4. Use a simple film coat only when appearance, swallowability, or moisture protection justifies the added cost.

Direct compression

Direct compression can reduce processing steps and lower manufacturing cost. Microcrystalline cellulose, anhydrous lactose, mannitol, or dicalcium phosphate can support this approach. The primary risks are segregation, poor flow, and content-uniformity failures caused by the low dose of loperamide.

A co-processed excipient may improve flow and compaction but can increase raw-material cost and supplier dependence. For a value-oriented private-label brand, a conventional blend is usually more attractive unless manufacturing-scale data show persistent compression problems.

Dry granulation

Roller compaction can improve blend uniformity and flow without introducing water. This is useful where the active ingredient or selected excipients have poor flow or where the manufacturing site wants to avoid a wet-granulation drying step.

The risk is excessive densification. Overcompacted granules can produce hard tablets with slow disintegration. The formulation should therefore balance granule strength with disintegrant access and tablet porosity.

Wet granulation

Wet granulation can improve content uniformity and compressibility but adds equipment, drying time, solvent-management requirements, and process-validation burden. It is less attractive for a mature OTC product unless the blend cannot meet uniformity or mechanical-strength requirements through direct compression or dry granulation.

What formulation patents protect GoodSense Anti-Diarrheal?

No meaningful active-ingredient patent protection is expected for a standard loperamide hydrochloride OTC product. Loperamide has been marketed for decades, and ordinary loperamide tablets are available from multiple generic and private-label manufacturers.

Potential formulation-related intellectual property could cover:

• Chewable or orally disintegrating loperamide dosage forms.
• Taste-masked loperamide compositions.
• Modified-release delivery systems.
• Specific excipient ratios or granulation processes.
• Unit-dose packaging or tamper-evident delivery systems.
• Combination products containing loperamide and another active ingredient.
• Manufacturing methods that improve content uniformity or dissolution.

Those rights would not automatically block a conventional GoodSense-type immediate-release tablet. A formulation patent would need claims that read on the specific product, process, or dosage form. Excipients themselves are rarely a durable exclusivity strategy because common materials such as microcrystalline cellulose, crospovidone, croscarmellose sodium, and magnesium stearate are widely available and generally unpatented in their ordinary uses.

What is the FDA regulatory status of GoodSense Anti-Diarrheal?

Loperamide is regulated in the United States as an OTC antidiarrheal under FDA requirements for active ingredients, labeling, dosage, warnings, and permitted uses. The applicable OTC framework is codified in 21 C.F.R. Part 335, subject to the FDA’s OTC monograph system. [2]

The product must comply with requirements covering:

• Active ingredient identity and concentration.
• Permitted indications.
• Directions and age-related use restrictions.
• Warnings concerning persistent diarrhea, fever, bloody stool, and dehydration.
• Maximum daily dosing.
• Packaging and labeling requirements.
• Manufacturing controls under current good manufacturing practice rules.

FDA has warned that excessive loperamide doses can cause serious cardiac events, including QT-interval prolongation, torsades de pointes, cardiac arrest, and death. Formulation development cannot eliminate this systemic safety risk at excessive doses. Packaging, unit-dose formats, prominent warnings, and controlled distribution can reduce misuse exposure but do not replace regulatory compliance. [5]

What is the Orange Book status of GoodSense Anti-Diarrheal?

A conventional GoodSense loperamide product marketed under the OTC monograph system is generally not expected to have an Orange Book patent listing. The Orange Book primarily identifies approved prescription drug products and certain approved nonprescription products linked to approved applications. A private-label OTC monograph product does not normally obtain commercial protection through Orange Book-listed patents.

This has several consequences:

• There is generally no Paragraph IV certification tied to the ordinary GoodSense product.
• There is no Hatch-Waxman patent timetable comparable to a newly approved prescription NDA.
• Generic and private-label competitors can enter based on compliance with the applicable OTC requirements.
• Competitive barriers arise mainly from manufacturing, supply, quality, branding, distribution, and packaging.

When does loperamide lose exclusivity?

Loperamide’s core pharmaceutical exclusivity expired many years ago. The product is now a mature generic and OTC active ingredient. GoodSense therefore does not rely on active-ingredient patent exclusivity.

Exclusivity category	GoodSense position
New chemical entity exclusivity	Expired
Original composition patent	Expired
Standard OTC monograph access	Available to compliant manufacturers
Orange Book patent protection	Generally absent for the ordinary product
Biosimilar exclusivity	Not applicable
Formulation patent exposure	Product-specific and potentially relevant only for differentiated dosage forms
Market protection	Brand recognition, retail placement, cost, supply reliability

The absence of core patent protection increases the value of operational advantages. A manufacturer with lower conversion cost, dependable loperamide supply, strong quality systems, and flexible packaging can compete effectively without owning a drug patent.

What formulation opportunities exist for GoodSense Anti-Diarrheal?

Chewable loperamide

A chewable product could improve convenience for consumers who have difficulty swallowing tablets. The principal technical challenge is taste. Loperamide hydrochloride can require flavoring, sweetening, and taste-masking technology.

Potential excipient categories include mannitol, xylitol, sorbitol, sucralose, acesulfame potassium, flavor systems, and polymeric taste-masking coatings. Sugar alcohols can affect tablet hardness, hygroscopicity, and gastrointestinal tolerability. A chewable product would require careful control of mouthfeel and aftertaste.

Orally disintegrating tablets

An orally disintegrating tablet could target travelers and consumers seeking rapid administration without water. The commercial benefit is convenience rather than proven superior antidiarrheal efficacy.

Formulation requirements include:

• Fast disintegration.
• Low tablet friability.
• Taste masking.
• Moisture protection.
• Specialized packaging, often aluminum blister packs.
• Strong stability data under humidity stress.

Packaging cost may materially reduce the margin advantage of an orally disintegrating product.

Color-free and allergen-conscious formulations

A simplified, color-free formulation can target consumers seeking fewer inactive ingredients. The opportunity is strongest in e-commerce and specialty retail, where product descriptions can communicate excipient exclusions.

Potential claims may include:

• No artificial color.
• Gluten-free, if substantiated.
• Lactose-free, if the formulation excludes lactose.
• Dye-free.
• Minimal inactive ingredients.

Each claim requires supplier qualification and documentation. A formulation change that removes a colorant or lactose may require new stability, dissolution, and labeling work.

Unit-dose and tamper-evident formats

Unit-dose packaging can support travel use, pharmacy distribution, and institutional channels. It may also reduce the risk of accidental overuse by limiting the quantity immediately accessible to the consumer.

Blister packaging provides better portability and dose tracking than bulk bottles but costs more. Bottles remain attractive for mass retail because of lower packaging cost and faster filling operations.

Which companies are challenging GoodSense Anti-Diarrheal?

Competition is primarily commercial rather than patent-based. The relevant competitors include:

• Johnson & Johnson consumer-health products marketed under Imodium A-D.
• Retailer-owned brands sold through pharmacy and mass-merchandise chains.
• Perrigo and other private-label OTC manufacturers.
• Online marketplace brands.
• International manufacturers supplying regional loperamide products.

The competitive set is fragmented because the active ingredient is mature and the dosage form is technically straightforward. Retail placement, price, package count, customer reviews, and supply continuity often matter more than formulation differentiation.

What generic launch risks exist for GoodSense Anti-Diarrheal?

A competing manufacturer could launch a conventional loperamide product without waiting for expiration of a GoodSense-specific patent estate if the product complies with the OTC monograph and does not infringe a relevant formulation or process patent.

The principal launch risks are:

1. Failure to meet content-uniformity requirements because of the low active dose.
2. Slow dissolution caused by over-lubrication or excessive granule density.
3. Tablet capping, sticking, or friability during high-speed compression.
4. Stability failures from moisture-sensitive excipients or packaging.
5. Incorrect dosing or warning language.
6. Inadequate supplier qualification for loperamide hydrochloride.
7. Retail rejection caused by poor packaging, labeling, or barcode execution.
8. Consumer safety concerns related to excessive dosing and abuse.

How strong is the GoodSense patent estate?

The patent estate for a standard GoodSense loperamide tablet is likely weak or immaterial. The product’s defensibility is based on execution rather than patent exclusivity.

Asset	Likely strength
Loperamide active ingredient	None as a current exclusivity barrier
Standard immediate-release tablet	Low patent differentiation
Conventional excipients	Low
Brand and retail placement	Moderate commercial value
Supply and manufacturing capability	Moderate to high operational value
Chewable technology	Potentially moderate if protected and difficult to design around
Orally disintegrating technology	Potentially moderate, subject to claim scope
Packaging and adherence systems	Low to moderate
Consumer recognition	Moderate, depending on channel penetration

A diligence review should focus on current product labels, supplier agreements, manufacturing records, regulatory filings, trademark rights, and any formulation-specific patents held by the manufacturer or its suppliers. The absence of active-ingredient exclusivity does not eliminate contract or trade-secret protection around manufacturing methods.

What licensing deals could create commercial value?

Licensing opportunities are more likely to involve manufacturing and formulation technology than the loperamide molecule. Relevant targets include:

• Co-processed excipient platforms that improve content uniformity.
• Taste-masking technology for chewable or orally disintegrating products.
• Moisture-barrier blister systems.
• Contract manufacturing agreements with validated loperamide capacity.
• Retailer-exclusive packaging or dosage configurations.
• International rights for country-specific loperamide formulations.
• Combination products that satisfy separate regulatory requirements.

A license is commercially attractive only if it reduces cost, improves quality, creates a defensible dosage form, or enables a channel that a conventional tablet cannot efficiently serve. A patent license covering ordinary excipient selection would have limited value unless it provides a measurable manufacturing advantage.

How does GoodSense compare with Imodium A-D?

Category	GoodSense Anti-Diarrheal	Imodium A-D
Active ingredient	Loperamide hydrochloride	Loperamide hydrochloride
Typical strength	2 mg	2 mg
Market position	Value and private label	Branded consumer product
Patent dependence	Low	Low for the mature active ingredient
Retail advantage	Price and retailer distribution	Brand recognition and marketing
Formulation differentiation	Usually limited	May include branded dosage and packaging variants
Consumer trust	Retailer-dependent	Established branded recognition
Commercial risk	Margin compression and substitution	Private-label erosion and mature-category competition

The central commercial distinction is brand equity, not pharmacological exclusivity. GoodSense can compete through lower pricing, availability, package-size optimization, and online search visibility.

What is the revenue exposure and commercial opportunity?

Loperamide products are low-cost OTC medicines with high substitution risk. Revenue exposure is therefore driven by unit volume, retail distribution, and margin per package rather than high price per treatment course.

The most realistic opportunities are:

• Retailer-exclusive low-price packs.
• Travel-size packaging.
• Larger-count household packs.
• Unit-dose blister packs.
• Dye-free or simplified-excipient versions.
• Chewable or orally disintegrating products.
• E-commerce listings optimized around symptom, ingredient, and dosage-form searches.
• Institutional and pharmacy supply contracts.

A new excipient system should be adopted only if it improves one of four measurable outcomes: manufacturing yield, product stability, consumer convenience, or channel access. An excipient change that increases cost without improving one of those outcomes is unlikely to support a sustainable premium.

Key Takeaways

• GoodSense Anti-Diarrheal is a loperamide hydrochloride OTC product, typically supplied at 2 mg.
• The product has no meaningful active-ingredient exclusivity remaining.
• Conventional excipients should prioritize content uniformity, rapid disintegration, tablet strength, and low manufacturing cost.
• Superdisintegrant selection and lubricant control are central technical variables.
• Chewable and orally disintegrating formats offer the clearest formulation-led opportunities, but taste masking and packaging can reduce margins.
• GoodSense is generally not an Orange Book patent-driven product.
• Paragraph IV litigation and biosimilar competition are not central risks for the ordinary OTC formulation.
• Commercial defensibility depends on price, supply reliability, retailer access, packaging, consumer trust, and manufacturing quality.
• Excess-dose safety concerns make packaging, labeling, and distribution controls important parts of the product strategy.
• The most valuable licensing targets are formulation, taste-masking, packaging, and manufacturing technologies rather than loperamide IP.

FAQs

Is GoodSense Anti-Diarrheal the same as Imodium?

Both products generally contain loperamide hydrochloride at a 2 mg strength. They may differ in excipients, packaging, manufacturer, price, and brand presentation.

Can a company patent a new loperamide excipient formulation?

Yes. A formulation may be patentable if it contains a novel and non-obvious composition, delivery system, manufacturing process, or performance characteristic. Ordinary use of common tablet excipients is unlikely to create strong patent protection.

Does loperamide require a prescription in the United States?

Standard low-dose loperamide products are marketed over the counter in the United States, subject to FDA labeling, dosage, warning, and manufacturing requirements. [2]

Is a GoodSense loperamide product subject to biosimilar competition?

No. Biosimilar regulation applies to biological products. Loperamide is a small-molecule drug.

Which excipient is most important for rapid loperamide tablet disintegration?

The superdisintegrant system is usually the most important excipient category, but performance also depends on tablet porosity, compression force, lubricant level, granule density, and moisture content.

References

1. U.S. National Library of Medicine. (n.d.). Loperamide hydrochloride drug information. DailyMed. https://dailymed.nlm.nih.gov/

2. Electronic Code of Federal Regulations. (n.d.). 21 C.F.R. Part 335: Antidiarrheal products for over-the-counter human use. https://www.ecfr.gov/

3. U.S. Food and Drug Administration. (n.d.). Loperamide hydrochloride. Drug database and regulatory information. https://www.fda.gov/

4. U.S. National Library of Medicine. (n.d.). DailyMed: Current drug labeling database. https://dailymed.nlm.nih.gov/

5. U.S. Food and Drug Administration. (2018). FDA limits packaging for anti-diarrhea medicine loperamide, including Imodium A-D, to encourage safe use. https://www.fda.gov/-drugsafety-and-availability/fda-drug-safety-communication-fda-limits-packaging-anti-diarrhea-medicine-loperamide-encourage-safe-use