{"product_id":"otc-drug-establishment-registration-labeler-code-fda","title":"OTC Drug Establishment Registration + Labeler Code (FDA)","description":"\u003cp\u003eSunscreens, acne treatments, antiperspirants and other OTC monograph drugs are drugs in the US, not cosmetics. The establishment that makes them must register with FDA and obtain a labeler code before listing products. We prepare and submit both as SPL files through FDA's electronic system. FDA fees and laboratory testing are extra. £1,450.\u003c\/p\u003e\u003ch2\u003eWhat is OTC drug establishment registration?\u003c\/h2\u003e\u003cp\u003eUnder \u003cstrong\u003eFD\u0026amp;C Act section 510\u003c\/strong\u003e and \u003cstrong\u003e21 CFR Part 207\u003c\/strong\u003e, establishments that manufacture, repack or relabel \u003cstrong\u003edrugs\u003c\/strong\u003e for the US must \u003cstrong\u003eregister with FDA\u003c\/strong\u003e and \u003cstrong\u003elist\u003c\/strong\u003e each drug. Many personal-care products are \u003cstrong\u003eOTC monograph drugs\u003c\/strong\u003e: \u003cstrong\u003esunscreens\u003c\/strong\u003e, \u003cstrong\u003eacne treatments\u003c\/strong\u003e with benzoyl peroxide or salicylic acid, \u003cstrong\u003eantiperspirants\u003c\/strong\u003e and \u003cstrong\u003eanti-dandruff\u003c\/strong\u003e products. Registration is made in \u003cstrong\u003eStructured Product Labeling (SPL)\u003c\/strong\u003e format, and a \u003cstrong\u003elabeler code\u003c\/strong\u003e is needed before NDC listing. Foreign establishments must name a \u003cstrong\u003eUS agent\u003c\/strong\u003e.\u003c\/p\u003e\u003ch3\u003eWhat's included in your establishment registration?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct check\u003c\/strong\u003e: Confirms your products are OTC drugs and the relevant monograph\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabeler code request\u003c\/strong\u003e: Prepared and submitted as an SPL file\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eEstablishment registration\u003c\/strong\u003e: Prepared and submitted as an SPL file\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS agent check\u003c\/strong\u003e: Confirms the US agent for a foreign establishment\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAnnual renewal date\u003c\/strong\u003e: Registration renewed each year, 1 October to 31 December\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this service for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eManufacturers of sunscreen, acne, antiperspirant and anti-dandruff products\u003c\/li\u003e\n\u003cli\u003eUK and EU brands making SPF products for the US\u003c\/li\u003e\n\u003cli\u003eAmazon US sellers asked for drug registration\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this service not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eLaboratory testing.\u003c\/strong\u003e Laboratory testing, lab fees and test reports are not included. SPF and other monograph tests are arranged separately.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA fees.\u003c\/strong\u003e Any FDA OMUFA facility fee is extra and passed through at cost; the current amount is confirmed at order.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct (NDC) listings.\u003c\/strong\u003e Available separately per SKU.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eA US agent.\u003c\/strong\u003e Foreign establishments need one; available on request.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA approval.\u003c\/strong\u003e FDA does not issue registration certificates or verification letters, and registration or listing is not FDA approval.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does OTC Drug Establishment Registration + Labeler Code work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your details\u003c\/strong\u003e: Establishment, products, formulas and DUNS number.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCheck\u003c\/strong\u003e: We confirm the products are OTC monograph drugs.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubmit\u003c\/strong\u003e: We submit the labeler code request and the establishment registration.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eConfirmed\u003c\/strong\u003e: We send your labeler code and registration confirmation. FDA processing time varies and is outside our control, so we do not guarantee a date.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch3\u003eWhat US law and FDA rules apply?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 510\u003c\/strong\u003e — drug establishment registration and listing\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 207\u003c\/strong\u003e — registration, listing and NDC rules\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 505G\u003c\/strong\u003e — OTC monograph drugs\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 744M\u003c\/strong\u003e — OTC monograph drug user fees (OMUFA)\u003c\/li\u003e\n\u003cli\u003eOfficial sources:\u003c\/li\u003e\n\u003cli\u003e[Drug Registration and Listing System (FDA)](https:\/\/www.fda.gov\/drugs\/guidance-compliance-regulatory-information\/electronic-drug-registration-and-listing-system-edrls)\u003c\/li\u003e\n\u003cli\u003e[OTC Monograph Drug User Fee Program (FDA)](https:\/\/www.fda.gov\/industry\/fda-user-fee-programs\/over-counter-monograph-drug-user-fee-program-omufa)\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eRelated services\u003c\/h3\u003e\u003cp\u003eBrowse \u003ca href=\"\/nl\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/nl\/products\/otc-drug-listing-with-fda-ndc-per-sku\"\u003eOTC Drug Listing with FDA (NDC), per SKU\u003c\/a\u003e, \u003ca href=\"\/nl\/products\/otc-drug-facts-label-review-monograph-conformity\"\u003eOTC Drug Facts Label Review (Monograph Conformity)\u003c\/a\u003e, \u003ca href=\"\/nl\/products\/us-cosmetic-label-review-mocra-fda\"\u003eUS Cosmetic Label Review (MoCRA \u0026amp; FDA)\u003c\/a\u003e.\u003c\/p\u003e\u003cp\u003ePrepared by \u003cstrong\u003ePhoenix Compliance Services\u003c\/strong\u003e and reviewed by \u003cstrong\u003e\u003ca href=\"https:\/\/www.linkedin.com\/in\/shamuelshees\" rel=\"author\"\u003eSyed Muhammad Shamuel Shees\u003c\/a\u003e, US Regulatory Lead\u003c\/strong\u003e, with US agent and responsible person roles provided by Phoenix Safety Consultants LLC (USA), a sister company of Phoenix Compliance Services. FDA fees are not included and are passed through where they apply.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Default Title","offer_id":67824343351373,"sku":null,"price":1450.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/otc-drug-establishment-registration-labeler-code-fda.webp?v=1793176385","url":"https:\/\/phoenixcosmeticsafety.com\/nl\/products\/otc-drug-establishment-registration-labeler-code-fda","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}