Product Management Group
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Industry — OTC & Specialty

OTC is regulated like a drug because it is a drug. We manufacture it accordingly.

Over-the-counter pain relief, first aid, sanitization, anti-itch, and other monograph-regulated products require a level of manufacturing rigor that most contract manufacturers can't provide. PMG's facilities and/or partner facilities are FDA-registered and built for monograph compliance, and the products they make carry an NDC listing where required.

Product Management Group makes OTC products, including acne treatments and sunscreens. Stock OTC formulas start at 5,000 units and take 90–150 days. Custom OTC formulas start at 5,000–10,000+ units and take 4–6 months, not including regulatory or registration time.

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Unbranded topical relief tubes, a roll-on bottle and adhesive bandages
Formats & minimums

Product formats we make

Translucent gel tube beside white topical airless pump bottles

Gels & Topicals

Clear gels, cooling topicals and roll-ons.

Min order 1,000 unitsExplore →

The otc & specialty categories we manufacture every day.

From monograph-regulated topical analgesics to FDA-listed sanitizers and specialty OTC formats, we handle the categories that demand pharmaceutical-grade manufacturing.

Topical pain relief
  • Menthol and methyl salicylate topicals
  • Capsaicin topicals
  • Cooling and warming gels, creams, sprays, roll-ons
  • Patch and adhesive delivery systems
First aid & sanitization
  • Antiseptic cleansers and sprays
  • Antibacterial topicals
  • Burn relief
  • Anti-itch (hydrocortisone, calamine)
  • Antifungal topicals
  • Hand sanitizer (gel, liquid, foam, spray)
  • Surface sanitizers
  • Antibacterial hand soap
  • Sanitizing wipes
Specialty OTC
  • Foot care
  • Acne treatment (benzoyl peroxide, salicylic acid)
  • Eczema and barrier-repair products

Three reasons OTC founders work with us instead of a generic contract manufacturer.

01

Monograph compliance built into formulation

OTC products are regulated under the FDA (Food and Drug Administration) monograph system, which defines exactly which active ingredients are permitted, at what concentrations, for what claims. Our chemists formulate within the monograph from day one, checking the intended dosage form, route of administration, active ingredient, and claim against the applicable conditions rather than trying to retrofit drug compliance after a formula is complete. Where a product falls outside a monograph, the development conversation changes: the path may require a different regulatory strategy rather than a simple production adjustment.

02

Drug Facts panel and labeling discipline

OTC labeling is the most regulated labeling in consumer products. Every element of the Drug Facts panel has specific requirements, including active ingredients, purpose, uses, warnings, directions, and inactive ingredients. The panel must be presented in the prescribed order and format, and the marketing language around it cannot undermine the approved drug facts. Errors can create regulatory exposure, delay a launch, or lead to retailer rejection, so label review belongs in formulation and packaging planning from the start.

03

NDC registration and FDA establishment registration

Manufacturing OTC products requires FDA-registered drug establishment facilities. Our facilities maintain these registrations as a baseline. An NDC listing identifies the labeler, product, and package configuration in FDA's National Drug Code directory; it is not the same thing as FDA approval, but it is part of the product's required regulatory record. We help coordinate the information and submission workflow while keeping the brand clear on which responsibilities belong to the labeler and which belong to the manufacturing establishment.

OTC manufacturing capabilities at PMG.

  • OTC monograph formulation
  • Topical analgesic manufacturing
  • Antiseptic and sanitizer manufacturing
  • Anti-itch and antifungal manufacturing
  • Active ingredient and dosage-form review
  • Drug Facts panel design and review
  • NDC listing facilitation
  • FDA drug establishment-registered facilities
  • Pharmaceutical-grade GMP (21 CFR Part 210/211)
  • Batch and lot documentation
  • Stability and package compatibility coordination
  • Roll-on, spray, gel, cream, and patch filling
  • Tamper-evident packaging coordination
  • OTC inventory traceability and FEFO fulfillment

The compliance landscape for OTC brands launching today.

OTC products are drugs sold without a prescription, so the compliance question starts before the first batch. FDA's OTC drug review system establishes conditions under which a category can be marketed without an individual product approval: an applicable monograph identifies the permitted active ingredients, their concentrations, dosage forms, uses, labeling conditions, and other requirements. In plain language, a monograph is the rulebook for a category. A product that fits the current conditions can follow that pathway; a product that does not may need a different regulatory route rather than simply using a familiar ingredient. The manufacturing establishment must be registered with FDA as a drug establishment and must list the drugs it manufactures, prepares, propagates, compounds, or processes as required. The finished product also needs an NDC listing, which identifies the labeler, product, and package configuration in the National Drug Code directory. An NDC listing is not FDA approval and does not replace the labeler's responsibility for the product, but it is part of the required record for an OTC launch. The Drug Facts panel then communicates the regulated information in the required format: active ingredients and their purposes, uses, warnings, directions, and inactive ingredients. Marketing copy must be consistent with those facts and cannot quietly turn a cosmetic claim into a drug claim. The 2020 CARES Act replaced the older rulemaking process for OTC monographs with an administrative order framework. It also established a user-fee program and changed how FDA can update monograph conditions, including through proposed and final orders and an administrative order process for urgent conditions. That reform did not make OTC products unregulated; it changed the mechanism used to maintain the rules. For a brand, the practical work remains the same: establish the category and claim, formulate to the applicable conditions, manufacture under the right GMP framework, maintain the required establishment and product records, and review the label against the current requirements. Stock OTC formulas typically begin at a 5,000-unit MOQ with a 90–150 day launch window; custom OTC formulations typically begin at 5,000–10,000+ units and take 4–6 months, not including regulatory or registration time, because development, testing, and documentation are more extensive.

OTC & Specialty questions buyers ask us first.

Typically 5,000 units minimum for stock OTC formulas, and 5,000–10,000+ for custom OTC formulations. The difference reflects the extra setup, development, and production complexity of a custom drug product rather than a different quality standard. MOQ should be considered alongside package format, active ingredient, channel requirements, and the amount of inventory your launch plan can responsibly carry. For a brand entering OTC with a stock formula, the 5,000-unit starting point is the figure to use for initial planning; a custom brief should be planned around the larger run.

No — PMG's facilities and/or partner facilities maintain the registration required for the manufacturing establishment. You will still have responsibilities as the brand or labeler, including the finished product's regulatory records and NDC listing, which we facilitate. Establishment registration belongs to the facility that manufactures, prepares, propagates, compounds, or processes the drug; it is not a substitute for product-level obligations. The exact allocation of responsibilities should be documented in the manufacturing agreement and confirmed against the product and labeler structure for your launch.

Private label using stock OTC formulas: 90 to 150 days. Custom OTC formulations: 4 to 6 months, not including regulatory or registration time. The clock includes more than filling: formula selection or development, active-ingredient and claim review, package selection, Drug Facts label work, testing, production scheduling, and the records needed for a compliant launch. A stock formula can move faster because the base specification already exists. Custom work takes longer because the formula and package have to be developed and evaluated before a production-ready specification is approved.

An OTC product makes a drug claim or contains an active ingredient regulated as a drug, so it is manufactured and labeled under a drug framework. That brings monograph conditions, drug establishment registration, NDC listing obligations, Drug Facts labeling, and GMP requirements under 21 CFR Parts 210 and 211 into the project. A cosmetic is not allowed to make those drug claims and follows a different regulatory framework, including MoCRA (Modernization of Cosmetics Regulation Act) requirements that apply to cosmetics. The same facility can support both categories, but the formula, records, label review, and lot controls cannot be treated as interchangeable.

An OTC monograph is FDA's category rulebook. It describes the active ingredients, concentrations, dosage forms, intended uses, labeling conditions, and other requirements under which a category of nonprescription drug can be marketed without an individual product approval. A manufacturer and brand still have to follow the conditions; being in a familiar category is not permission to make any claim or use any concentration. If the intended product falls outside the applicable monograph conditions, it needs a different regulatory assessment before formulation and launch planning proceed.

NDC listing identifies the labeler, the specific drug product, and its package configuration in FDA's National Drug Code directory. The process requires accurate information about the product, ingredients and dosage form, packaging, and the responsible labeler, followed by the applicable listing submission and maintenance. An NDC listing is not the same as FDA approval or an endorsement of the product. It is one part of the regulatory record, alongside establishment registration, compliant manufacturing, and a Drug Facts label that matches the product and its permitted claims.

Yes, provided the partner maintains the separation each category requires. An OTC product such as hand sanitizer is a drug, while a standard personal care product without drug claims is generally a cosmetic. They can use one accountable partner for development, manufacturing, packaging, and fulfillment, but the OTC program still needs drug establishment registration, monograph or other regulatory review, Drug Facts labeling, GMP controls, and lot and expiration traceability. Fulfillment systems should preserve those lot records and use FEFO rotation for OTC inventory. The shared relationship is efficient; the compliance records and production controls are not one-size-fits-all.

Yes. OTC drug labeling uses the standardized Drug Facts format so consumers can find the active ingredients, purpose, uses, warnings, directions, and inactive ingredients in a consistent order. The label is not just packaging copy: its contents and presentation are part of the product's regulatory compliance. Claims on the front panel and website also need to remain consistent with the product's permitted uses and the information in Drug Facts. That is why label review, formula review, and package selection should happen as one connected process rather than at the end of manufacturing.
Related guides

From the PMG Journal

OTC & regulatory

What Does It Take to Manufacture an OTC Acne Product?

Allowed actives and strengths, Drug Facts labeling, NDCs and registration, and realistic OTC minimums and timelines.

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Volume planning

MOQ and Manufacturing Volume: What Actually Matters

Why minimums exist, what they cost below volume, and how to plan a first run you can sell through.

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Build your otc & specialty line with one accountable partner.

OTC manufacturing rewards manufacturers who treat it as the pharmaceutical-adjacent discipline it actually is — and punishes everyone else with Warning Letters and recalled inventory.

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