OTC Listings, Labels & Monographs — Done Right
We help OTC brands and manufacturers set up labeler codes, submit compliant SPL/NDC drug listings, clean up labels & claims, and align products to the right OTC monograph (505G) so you can manufacture and sell without preventable regulatory friction.
Why OTC Gets Brands in Trouble
OTC is “consumer-facing,” but it’s still drug regulation: monograph conditions, Drug Facts formatting, establishment registration, listing, and claims boundaries. The biggest risk is assuming your product is “just like cosmetics” — and getting flagged by FDA, retailers, or contract manufacturers who need correct NDCs before production.
- Correct category: OTC drug vs cosmetic vs device (and how your claims create that category).
- Monograph fit: active(s), dosage form, indications, warnings, and directions must match allowed conditions.
- Data + documentation: you need defensible rationale, correct SPL structure, and traceable labeling decisions.
- System accuracy: labeler code, establishment registration (when required), and SPL/NDC listing must align.
OTC Programs
Same structure as your cosmetics page—clear programs, clean deliverables, transparent bands.
OTC SPL/NDC Drug Listing
Typical range: $249–$600
For brands that need a compliant OTC drug listing submitted correctly (and fast).
- SPL build + submission for OTC listing
- NDC assignment coordination and basic validation checks
- Label-to-SPL consistency check (Drug Facts, statements, directions)
Labeler Code Setup
Typical range: $250–$450
For companies that need a labeler code request prepared and aligned to the correct firm identity.
- Labeler code request preparation + submission support
- Firm identity cleanup (name/address consistency, DUNS/contacts alignment)
- Practical guidance on packaging configurations and NDC strategy
OTC Label Review & Claims Cleanup
Typical range: $450–$1,500 per SKU
For Drug Facts panels, PDP/outer cartons, and websites that must match monograph conditions and platform policies.
- Drug Facts formatting + content review (active, purpose, uses, warnings, directions)
- Claims sweep: website, Amazon, TikTok, Shopify (drug claims that create risk)
- Redlines for designers (keep it on-brand while compliant)
OTC Monograph (505G) Fit & Strategy
Typical range: $900–$3,500
For brands that need to confirm if they truly fit an OTC monograph and what changes are required to stay within it.
- Monograph mapping: active(s), dosage form, indications, labeling requirements
- Gap list + “what to change” plan (label, formula, directions, warnings)
- Practical go/no-go recommendation with risk explanation
Who We Help
OTC Startups & DTC Brands
Teams moving fast that need the OTC basics correct before scaling ads, Amazon, or retail distribution.
Contract Manufacturers
CMOs that need accurate labeler/NDC setup and consistent SPL/labeling before they will schedule production.
Importers & Private Label
Importers/private label brands who need clear responsibility boundaries and defensible monograph positioning.
Sunscreen & “Borderline” Claims
Products where drug claims, SPF, acne, antifungal, or antiseptic language can shift risk instantly.
Marketplace-Heavy Sellers
Brands that need claims aligned across listings, A+ content, PDPs, and social media to avoid takedowns.
Multi-SKU Portfolios
Companies that need consistent NDC strategy and templates across packaging sizes, scents, and variations.
How We Run OTC Engagements
Clean inputs, correct category decisions, and submission-ready outputs.
Inventory Products & Claims
We review formula, actives, intended use, channels, and existing labels/Drug Facts to define the true regulatory category.
Monograph Mapping
We map your product to the applicable OTC monograph conditions and identify gaps in labeling and positioning.
Labeler, SPL & Listing
We prepare labeler code work (if needed), build compliant SPL, and align the listing to the final label.
Keep Listings Accurate
We set simple rules for new SKUs, packaging changes, label revisions, and marketplace content so you don’t drift out of compliance.
OTC FAQs
Do I need an NDC for every OTC product?
If your product is an OTC drug being listed, you typically need NDCs that correctly reflect the labeler/product/package configuration. We help you structure this so it’s consistent and scalable.
Can I list my OTC product if a contract manufacturer produces it?
Often yes, but the details matter: who is the labeler, who is manufacturing/packaging, and how the label reads. We align the business reality with the listing so you’re not relying on assumptions.
What’s the most common OTC mistake you see?
Claims and labeling drift: what’s on the website or Amazon no longer matches the Drug Facts panel, or indications exceed what the monograph allows. That’s where enforcement and platform issues usually start.
Are these pricing ranges fixed?
No—these are typical working bands. After a short discovery call we can provide a fixed or milestone quote based on SKU count, packaging variants, and how complete your inputs are today.
Talk Through Your OTC Plan
Share your active(s), dosage form, where you sell, and whether you already have a labeler code. We’ll outline a sequenced plan (monograph fit → labels → SPL/listing) with clear deliverables and a quote that matches your stage.
Based in Charleston, SC • Supporting brands, labs and manufacturers worldwide
Prefer direct email? info@verusfda.com