Quick answer: Standard shampoo is regulated as a cosmetic under MoCRA, requiring facility registration, product listing, and a U.S. Agent. Anti-dandruff shampoo is different — it's regulated as both a drug and a cosmetic simultaneously, with specific approved active ingredients and mandatory label wording. Orionex provides MoCRA cosmetic registration and U.S. Agent services starting at $650/year.
Two Different Products Under One Name
Most shampoo is a straightforward cosmetic: it cleans hair and scalp, and any additional claims — shine, volume, color protection — stay within cosmetic territory. But anti-dandruff shampoo is one of only a handful of OTC products regulated as both a drug and a cosmetic at the same time: a drug because it treats a medical condition (dandruff or seborrheic dermatitis), and a cosmetic because of its ordinary cleansing function. This dual status means dual compliance — not a choice between frameworks, but both simultaneously.
Standard Shampoo — A MoCRA Cosmetic
If your shampoo doesn't claim to treat dandruff, seborrheic dermatitis, psoriasis, hair loss, or any other medical condition, it's regulated as a standard cosmetic under MoCRA:
- Facility registration for your manufacturing site
- Product listing for each shampoo formulation
- A responsible person for adverse event monitoring
- U.S. Agent designation if manufacturing outside the U.S.
Anti-Dandruff Shampoo — A Combination Drug-Cosmetic Product
Under OTC Monograph M032 (21 CFR Part 358, Subpart H), FDA maintains a specific list of GRASE active ingredients approved for treating dandruff, seborrheic dermatitis, and psoriasis, each with defined concentration ranges:
- Coal tar — 0.5% to 5%, with the coal tar source and concentration specified on the label
- Pyrithione zinc — 0.3% to 2% for wash-off (rinse-out) formulas, or 0.1% to 0.25% for leave-on formulas
- Salicylic acid — at monograph-specified concentrations
- Selenium sulfide — at monograph-specified concentrations
Concentration matters, and so does intended use. Notice that pyrithione zinc has two different approved ranges depending on whether the product is rinsed out or left on the scalp — using the wrong concentration for your product's actual use pattern is a real compliance gap, not just a labeling nuance.
The Labeling Rules Most Brands Get Wrong
Anti-dandruff shampoo can't just say whatever sounds good in marketing copy. The monograph specifies exact required phrasing for the "Uses" section — the label must state the product "relieves" or "controls" dandruff symptoms, using the monograph's approved language rather than free-form marketing claims.
It gets more specific still: if your anti-dandruff shampoo also contains a topical analgesic (an anti-itch ingredient), the label is required to say "Anti-Dandruff/Anti-Itch Shampoo" or "Anti-Seborrheic/Anti-Itch Shampoo" — not a generic "for itchy, flaky scalp" tagline, but this specific combination-product naming convention.
Anti-Hair-Loss Shampoo Is Also a Drug Claim
Separately from dandruff treatment, any shampoo claiming to treat hair loss or prevent baldness is making a drug claim, triggering drug regulation rather than standard cosmetic compliance — a distinct category from the dandruff-treatment rules above, but the same underlying principle: a therapeutic claim about the body pulls the product out of pure cosmetic territory.
MoCRA Adverse Event Reporting — Applies Regardless
Whether your shampoo is a pure cosmetic or a combination drug-cosmetic product, MoCRA's adverse event reporting requirements apply to the cosmetic side of your compliance: serious adverse events (hospitalization, severe injury, death) must be reported to FDA within 15 business days of the responsible person receiving that information, and an annual summary report covering all adverse events, including minor reactions, must also be submitted.
U.S. Agent Requirement for Shampoo Manufacturers
Foreign facilities manufacturing standard cosmetic shampoo need a U.S. Agent under MoCRA. If your shampoo is also classified as a drug — anti-dandruff or anti-hair-loss formulas — a U.S. Agent is also required under the separate drug establishment registration framework.
Orionex Regulatory Solutions is a trusted MoCRA registration and U.S. Agent provider for shampoo manufacturers, physically based in Casper, Wyoming USA. Learn about our MoCRA cosmetic services →
Shampoo Compliance Checklist
Classify Your Shampoo's Claims
Standard cosmetic, or does it claim to treat dandruff, seborrheic dermatitis, or hair loss?
MoCRA Registration for the Cosmetic Function
Facility registration and product listing apply regardless of drug status.
Confirm Active Ingredient Concentration (If Anti-Dandruff)
Match your concentration to whether the product is rinsed out or left on.
Use Monograph-Approved Label Language
"Relieves" or "controls" dandruff — not free-form marketing claims.
Set Up Adverse Event Reporting
15 business days for serious events, plus an annual summary report.
What Orionex Provides for Shampoo Manufacturers
Orionex's fixed pricing for the cosmetic side of shampoo compliance:
- MoCRA Cosmetic Facility Registration + Product Listing + U.S. Agent: $650/year
Note: Orionex handles MoCRA registration, product listing, and U.S. Agent designation for shampoo. If your product also has a drug component (anti-dandruff or anti-hair-loss claims), it needs separate drug establishment registration too — contact us to discuss your specific formulation.
Why Shampoo Manufacturers Choose Orionex
MoCRA Registration & U.S. Agent for Shampoo — From $650/Year
Orionex handles MoCRA cosmetic facility registration, product listing, and U.S. Agent designation for shampoo manufacturers.