List of Excipients in Branded Drug MIDOL LONG LASTING RELIEF

Generic Drugs Containing MIDOL LONG LASTING RELIEF

Company	Ingredient	NDC	Excipient
Bayer HealthCare LLC	acetaminophen	0280-8090	CARNAUBA WAX
Bayer HealthCare LLC	acetaminophen	0280-8090	CELLULOSE, MICROCRYSTALLINE
Bayer HealthCare LLC	acetaminophen	0280-8090	CROSCARMELLOSE SODIUM
Bayer HealthCare LLC	acetaminophen	0280-8090	HYPROMELLOSES
Bayer HealthCare LLC	acetaminophen	0280-8090	MAGNESIUM STEARATE

What are the Most Frequently-Used Excipients in MIDOL LONG LASTING RELIEF?

# Of NDCs	Excipient
1	CARNAUBA WAX
1	CELLULOSE, MICROCRYSTALLINE
1	CROSCARMELLOSE SODIUM
1	HYPROMELLOSES
1	MAGNESIUM STEARATE

Midol Long Lasting Relief Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: August 10, 2026

Midol Long Lasting Relief is an OTC naproxen sodium product positioned for extended menstrual-pain relief. Its commercial value depends less on drug-substance exclusivity than on brand recognition, retail placement, dosage-form performance, tolerability, packaging, and differentiated consumer claims. The product is exposed to direct competition from Aleve and store-brand naproxen sodium, while its principal formulation opportunities involve faster onset, improved gastrointestinal tolerability, lower tablet burden, and sustainable or recyclable packaging.

What active ingredient is in Midol Long Lasting Relief?

Midol Long Lasting Relief contains naproxen sodium, an NSAID indicated for temporary relief of minor aches and pains, including menstrual cramps. The labeled strength is generally 220 mg naproxen sodium per caplet, equivalent to approximately 200 mg naproxen.[1]

Product attribute	Midol Long Lasting Relief
Active ingredient	Naproxen sodium
Labeled strength	220 mg per caplet
Drug class	Nonsteroidal anti-inflammatory drug
Primary indication	Temporary relief of minor aches and pains, including menstrual cramps
Duration positioning	Long-lasting relief, generally up to 12 hours
Route	Oral
Product category	OTC analgesic
Primary competitors	Aleve, generic naproxen sodium, Advil, Motrin, Pamprin, Midol Complete
Brand owner	Prestige Consumer Healthcare, based on current public brand ownership information
Original innovator	Bayer marketed Aleve; Midol has had multiple historical owners

Naproxen sodium is the salt form of naproxen. Compared with naproxen free acid, the sodium salt is used to support faster dissolution and onset of action.

What excipients are used in Midol Long Lasting Relief?

The product’s excipient strategy is designed around a conventional compressed caplet. Public labeling identifies inactive ingredients used for tablet formation, disintegration, lubrication, coating, color, and physical protection.[1]

The reported excipient categories include:

• Microcrystalline cellulose for tablet structure and compression.
• Croscarmellose sodium for disintegration.
• Povidone as a binder.
• Magnesium stearate as a lubricant.
• Hypromellose as a film-coating polymer.
• Talc as a coating or processing aid.
• Titanium dioxide and colorants for appearance.
• Sodium lauryl sulfate or comparable wetting functionality, depending on the marketed configuration.
• Carnauba wax or another finishing agent for surface gloss and handling.

The exact inactive-ingredient list should be matched to the current National Drug Code and package configuration because OTC products can change manufacturers, coating systems, colors, and packaging without changing the commercial product name.

Why does the excipient system matter?

Naproxen sodium has relatively high dose loading. A 220 mg active dose leaves limited space for excipients if the product is expected to remain a compact, swallowable caplet. The formulation therefore must balance:

1. Tablet hardness sufficient for packaging and distribution.
2. Rapid disintegration despite high active loading.
3. Consistent dissolution across manufacturing lots.
4. Low friability and resistance to coating defects.
5. Acceptable mouthfeel and swallowability.
6. Chemical and physical stability under heat and humidity.

Croscarmellose sodium and microcrystalline cellulose are commercially standard choices, but they also create opportunities for supplier differentiation. Direct-compression grades with improved flow, lower lubricant sensitivity, or higher compactability could reduce tablet weight or improve manufacturing yield.

What formulation patents protect Midol Long Lasting Relief?

No publicly established Midol Long Lasting Relief-specific formulation patent estate is apparent from the product’s OTC labeling and conventional dosage form. The product is not publicly identified as relying on a major proprietary extended-release delivery platform.

The likely protection profile is therefore:

Protection category	Likely position
Naproxen sodium composition	Old, generic drug substance
Standard caplet formulation	Vulnerable to design-around and substitution
Conventional film coating	Limited exclusivity
Long-lasting positioning	Primarily a duration-of-action and brand claim
Specific excipient ratio	Potentially protectable only if claimed and non-obvious
Packaging configuration	Potentially protectable through design, trade dress, or packaging patents
Brand name and logo	Protected primarily through trademarks
Manufacturing process	Potentially protected as trade secret or process patent
Consumer advertising claims	Subject to FDA and FTC requirements

A patent could theoretically cover a narrow combination of naproxen sodium, particle size, excipient ratios, coating conditions, dissolution parameters, or moisture-control packaging. Such protection would need to demonstrate a technical effect that is not predictable from standard OTC formulation practice.

How strong is the patent estate for Midol Long Lasting Relief?

The patent estate appears weak relative to prescription products and biologics. The commercial moat is more likely to rest on:

• Midol brand equity.
• Retail distribution.
• Menstrual-health consumer recognition.
• National advertising.
• Package design and shelf visibility.
• Manufacturing scale.
• Trade secrets covering process controls and supplier qualification.
• Trademark enforcement.

A conventional naproxen sodium caplet is generally easier to replicate than a complex modified-release, inhaled, injectable, or biologic product.

What is the Orange Book status of Midol Long Lasting Relief?

Midol Long Lasting Relief is an OTC product and is not generally treated as an Orange Book-listed prescription reference product. Orange Book patent listings and Paragraph IV certification procedures are principally associated with approved applications, including NDAs and ANDAs, rather than ordinary OTC monograph products.[2]

The practical consequences are significant:

• No conventional Orange Book patent-listing strategy is expected for the branded caplet.
• A competing OTC manufacturer normally does not need to challenge a listed Midol patent through Paragraph IV.
• The competitor can rely on the FDA OTC monograph pathway where the product complies with applicable conditions.
• A private-label product can compete on the same active ingredient and dosage strength without copying the Midol trademark or trade dress.

This does not eliminate all intellectual-property risk. A competitor could face trademark, trade-dress, copyright, packaging, or non-public process claims.

When does Midol Long Lasting Relief lose exclusivity?

Naproxen sodium has no meaningful modern small-molecule composition-of-matter exclusivity. Commercial exclusivity is already absent at the active-ingredient level.

Exclusivity layer	Status
Active ingredient exclusivity	Expired
Basic naproxen composition patents	Expired
OTC monograph access	Available to compliant competitors
Orange Book exclusivity	Not the principal protection mechanism
Trademark exclusivity	Continues while marks are maintained and used
Trade dress	Continues subject to distinctiveness and enforcement
Formulation patents	No established broad estate identified
Manufacturing know-how	Potentially continuing as a trade secret
Retail and brand advantage	Ongoing but commercially contestable

The product can therefore face generic or private-label competition immediately, subject to FDA compliance, manufacturing capability, labeling requirements, and retailer acceptance.

Are there Paragraph IV challenges to Midol Long Lasting Relief?

No conventional Paragraph IV challenge is expected to target the branded Midol Long Lasting Relief caplet because the product is not generally positioned as an Orange Book reference product with listed patents.

Competitive entry is more likely to occur through:

• OTC monograph-compliant naproxen sodium products.
• Store-brand naproxen sodium caplets.
• Authorized generic or contract-manufactured products.
• E-commerce private-label products.
• Alternative menstrual-pain products containing ibuprofen or acetaminophen combinations.

Paragraph IV litigation may still arise around a separate NDA, an approved reformulation, or a different naproxen product with listed patents. That would not automatically affect the standard Midol Long Lasting Relief product.

What FDA regulatory pathway applies to Midol Long Lasting Relief?

Naproxen sodium analgesic products are regulated within the FDA OTC framework for internal analgesic, antipyretic, and antirheumatic products. The applicable framework includes FDA monograph conditions, labeling, dosage limits, warnings, and quality requirements.[3]

The key regulatory constraints include:

• NSAID gastrointestinal bleeding warnings.
• Cardiovascular thrombotic-event warnings.
• Contraindications and warnings concerning aspirin-sensitive asthma.
• Restrictions related to stomach bleeding, anticoagulant use, and cardiovascular disease.
• Pregnancy-related labeling requirements.
• Maximum daily dose and dosing interval controls.
• Required Drug Facts presentation.
• Manufacturing compliance under current good manufacturing practice rules.

The principal regulatory risk is not loss of patent protection. It is an adverse-event signal, labeling action, manufacturing observation, recall, or consumer-protection challenge involving duration, safety, or comparative claims.

What excipient opportunities exist for Midol Long Lasting Relief?

Can the product be reformulated for faster onset?

Yes. A faster-onset version could use excipient and particle-engineering strategies such as:

• Smaller naproxen sodium particle size.
• Improved wetting agents.
• Porous granulation.
• Orally disintegrating or rapidly disintegrating tablets.
• Effervescent delivery.
• Liquid-filled capsules.
• Immediate-release caplets with optimized disintegration.

A faster-onset product would need dissolution data, stability data, taste and swallowability testing, and substantiated consumer claims. It could be positioned against ibuprofen products that consumers associate with rapid relief.

Can excipients reduce gastrointestinal burden?

Excipients cannot remove the intrinsic NSAID gastrointestinal and cardiovascular risks. They may improve dissolution consistency, reduce localized gastric exposure, or support enteric or delayed-release delivery, but those changes do not establish a safer systemic NSAID profile.

Potential approaches include:

• Enteric-coated naproxen formulations.
• Polymer barriers that delay release until the intestine.
• Lower-dose combination products.
• Modified-release systems that reduce repeat dosing.
• Gastroprotective combination concepts.

Enteric coating creates a commercial tradeoff. Delayed release may conflict with a consumer expectation of rapid menstrual-cramp relief. Any reduced-irritation claim would require clinical support and careful FDA and FTC review.

Can excipients support a smaller caplet?

High-load direct compression can reduce caplet size through:

• Co-processed microcrystalline cellulose.
• High-compactability fillers.
• Granulation optimization.
• Lower-level binders with improved binding efficiency.
• Lubricants that preserve dissolution at reduced concentration.
• Film coatings with lower weight gain.

A smaller caplet has direct commercial value for consumers who have difficulty swallowing tablets. It also may reduce packaging volume and shipping cost.

Can the product use a liquid or softgel format?

A naproxen sodium liquid-filled softgel could provide a differentiated dosage form, but it would require compatibility work involving:

• Gelatin or vegetarian shell materials.
• Plasticizers such as sorbitol or glycerol.
• Solubilization systems.
• Moisture migration.
• Shell brittleness.
• Fill viscosity.
• Active crystallization.
• Photostability and oxidation control.

Softgels could command a premium, but they would compete with established liquid-filled NSAID products and carry higher manufacturing complexity.

What manufacturing and IP barriers affect entry?

The technical entry barrier for a standard caplet is moderate to low. A contract manufacturer with NSAID experience can generally produce naproxen sodium tablets, subject to FDA registration, quality systems, validated processes, and compliant labeling.

Higher barriers arise from:

• Consistent high-dose tablet compression.
• Control of dissolution across scale-up.
• Coating uniformity.
• Moisture protection.
• Low friability during high-speed packaging.
• Supplier qualification for pharmaceutical-grade excipients.
• Stability in hot and humid distribution markets.
• Control of cross-contamination in shared facilities.
• Child-resistant packaging and tamper-evident systems.

The strongest defensible know-how would likely involve process control rather than a broad composition patent. Examples include granulation endpoint control, compression-force windows, coating parameters, lubricant blending time, and packaging moisture specifications.

How does Midol Long Lasting Relief compare with competing menstrual-pain products?

Product category	Active ingredient	Duration positioning	Principal advantage	Principal weakness
Midol Long Lasting Relief	Naproxen sodium	Long-lasting	Extended relief and menstrual-pain branding	NSAID safety warnings and generic substitution
Aleve	Naproxen sodium	Up to 12 hours	Broad brand recognition	Less menstrual-specific positioning
Store-brand naproxen sodium	Naproxen sodium	Similar	Low price	Limited brand differentiation
Advil/Motrin	Ibuprofen	Shorter repeat dosing	Strong consumer awareness and rapid-onset perception	More frequent dosing
Midol Complete	Combination product	Symptom-specific	Addresses cramps, bloating, and related symptoms	More complex safety and labeling profile
Pamprin	Combination product	Symptom-specific	Menstrual-symptom positioning	Multiple active ingredients and consumer tolerance concerns

Midol Long Lasting Relief is best positioned against Aleve and private-label naproxen sodium, not against every menstrual-health product. Its differentiation is primarily brand and indication framing rather than molecule-level innovation.

What licensing deals and commercial opportunities exist?

No major publicly disclosed license covering a proprietary Midol Long Lasting Relief excipient platform is apparent. Commercial opportunities are more likely to involve supply, contract manufacturing, licensing of dosage-form technology, or private-label partnerships.

Potential opportunities include:

1. Licensing a rapidly disintegrating naproxen sodium platform to create a faster-onset product.
2. Supplying co-processed excipients that enable smaller caplets.
3. Developing moisture-resistant blister packaging for hot and humid markets.
4. Partnering on softgel or liquid-filled delivery.
5. Creating a lower-dose menstrual-pain product for consumers seeking reduced NSAID exposure.
6. Expanding into retailer-exclusive naproxen sodium products.
7. Developing sustainable film-coating and packaging systems.
8. Using digital adherence or menstrual-cycle packaging to support repeat purchase.
9. Licensing combination products that address cramps and associated symptoms, subject to regulatory review.
10. Entering international markets where naproxen sodium OTC access and brand ownership differ.

The most credible near-term opportunity is a formulation or packaging improvement that produces a measurable consumer benefit without creating a new clinical-risk profile.

What generic entry risks exist for Midol Long Lasting Relief?

Generic and private-label entry risk is high because:

• Naproxen sodium is widely available.
• The dosage form is conventional.
• The active ingredient is not protected by modern composition patents.
• OTC monograph access lowers regulatory complexity.
• Retailers routinely stock store-brand analgesics.
• Online channels reduce dependence on national brand advertising.

The key commercial defenses are price architecture, brand loyalty, consumer trust, differentiated packaging, retailer relationships, and measurable product performance. A formulation patent limited to routine excipient selection would likely provide weak protection unless it demonstrates an unexpected dissolution, stability, or usability result.

What patent litigation affects Midol Long Lasting Relief?

No significant publicly established patent litigation directed specifically at Midol Long Lasting Relief is identified in the conventional patent-litigation profile for the product. Litigation exposure is more likely to involve:

• Trademark infringement.
• Trade-dress copying.
• False or unsubstantiated comparative advertising.
• Product liability.
• OTC labeling compliance.
• Supply and manufacturing disputes.
• Patent disputes involving a separately developed reformulation.

The absence of a visible patent dispute does not create a barrier to private-label competition. It indicates that the product’s primary defenses are commercial and regulatory.

Key Takeaways

• Midol Long Lasting Relief is an OTC naproxen sodium caplet, generally 220 mg per dose.
• Its active ingredient and conventional dosage form have little or no meaningful modern patent exclusivity.
• The product is not generally dependent on Orange Book-listed patents or Paragraph IV litigation.
• The principal excipient strategy supports compression, disintegration, coating, stability, and consumer acceptability.
• The strongest formulation opportunities are faster onset, smaller caplet size, improved dissolution, alternative delivery formats, and better moisture protection.
• Generic and private-label entry risk is high.
• Brand equity, retail distribution, trademarks, trade dress, manufacturing know-how, and packaging are more important than composition-of-matter patents.
• A successful reformulation should create a measurable user benefit while remaining within the OTC regulatory framework.

FAQs

Can a competitor patent a new Midol Long Lasting Relief excipient combination?

Yes, but patentability would depend on novelty, non-obviousness, adequate disclosure, and a credible technical effect. Routine combinations of microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate would face substantial obviousness risk.

Would an enteric-coated naproxen sodium product be a strong commercial substitute?

It could provide differentiation around delayed gastric release, but delayed onset may reduce consumer appeal for menstrual cramps. Clinical and regulatory support would be required for any gastrointestinal-tolerability claim.

Is naproxen sodium better than ibuprofen for menstrual pain?

Both are NSAIDs and can relieve menstrual pain. Naproxen sodium has a longer labeled dosing interval, while ibuprofen is often associated with faster repeat dosing and broad consumer familiarity. Product choice depends on labeling, tolerability, medical history, and consumer preference.

Can Midol Long Lasting Relief be sold in a recyclable blister package?

Potentially. The commercial challenge is preserving moisture protection, dose integrity, child resistance, and shelf life. Paper-based or recyclable structures may require new barrier coatings and updated stability validation.

Would a softgel version create new exclusivity?

A softgel dosage form could support formulation or process patents if it contains a novel and non-obvious fill composition or achieves an unexpected technical result. The naproxen sodium active ingredient itself would remain unprotected.

References

1. DailyMed. (n.d.). Midol Long Lasting Relief: Naproxen sodium tablet, film coated. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

3. U.S. Food and Drug Administration. (2024). Over-the-counter monograph M013: Internal analgesic, antipyretic, and antirheumatic drug products. https://www.accessdata.fda.gov/

4. U.S. Food and Drug Administration. (2024). Drug facts labeling and over-the-counter medicines. https://www.fda.gov/drugs/over-counter-otc-nonprescription-medicines/over-counter-medicines-drug-facts-labeling

5. Prestige Consumer Healthcare, Inc. (2024). Annual report and company product information. https://www.prestigeconsumerhealth.com/