{"product_id":"otc-drug-listing-with-fda-ndc-per-sku","title":"OTC Drug Listing with FDA (NDC), per SKU","description":"\u003cp\u003eEach OTC drug sold in the US, such as a sunscreen or acne treatment, must be listed with FDA and carry a National Drug Code. We prepare the drug listing SPL with your labeler code, product code and package codes, including the Drug Facts label, and submit it. Your establishment must already be registered. Testing is excluded. £395 per SKU.\u003c\/p\u003e\u003ch2\u003eWhat is OTC drug listing?\u003c\/h2\u003e\u003cp\u003eUnder \u003cstrong\u003e21 CFR Part 207\u003c\/strong\u003e, each \u003cstrong\u003edrug\u003c\/strong\u003e in US commercial distribution must be \u003cstrong\u003elisted\u003c\/strong\u003e with FDA, and each product and pack receives a \u003cstrong\u003eNational Drug Code (NDC)\u003c\/strong\u003e. For \u003cstrong\u003eOTC monograph drugs\u003c\/strong\u003e like \u003cstrong\u003esunscreens\u003c\/strong\u003e and \u003cstrong\u003eacne treatments\u003c\/strong\u003e, the listing names the active ingredients, the monograph and the \u003cstrong\u003eDrug Facts label\u003c\/strong\u003e. Listings are updated each June and December when information changes.\u003c\/p\u003e\u003ch3\u003eWhat's included in your drug listing?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eNDC assignment\u003c\/strong\u003e: Product and package codes built on your labeler code\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eListing SPL\u003c\/strong\u003e: Active ingredients, dosage form, route and monograph\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabel upload\u003c\/strong\u003e: Drug Facts label and packaging included in the SPL\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubmission\u003c\/strong\u003e: Through FDA's electronic system\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this listing for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands with a registered OTC drug establishment\u003c\/li\u003e\n\u003cli\u003eSellers of sunscreen, acne, antiperspirant and anti-dandruff products\u003c\/li\u003e\n\u003cli\u003eBrands adding new SKUs or pack sizes\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this listing 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.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eEstablishment registration and labeler code.\u003c\/strong\u003e Available separately.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDrug Facts label review.\u003c\/strong\u003e Available 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\u003c\/ul\u003e\u003ch3\u003eHow does OTC Drug Listing with FDA work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your product\u003c\/strong\u003e: Formula, labels and pack sizes.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrepare\u003c\/strong\u003e: We assign codes and build the listing SPL.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubmit\u003c\/strong\u003e: We submit the listing.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eConfirmed\u003c\/strong\u003e: We send your NDCs. 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(j)\u003c\/strong\u003e — drug listing\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 207\u003c\/strong\u003e — listing and NDC format\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR 201.66\u003c\/strong\u003e — Drug Facts labelling\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=\"\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/products\/otc-drug-establishment-registration-labeler-code-fda\"\u003eOTC Drug Establishment Registration + Labeler Code (FDA)\u003c\/a\u003e, \u003ca href=\"\/products\/otc-drug-facts-label-review-monograph-conformity\"\u003eOTC Drug Facts Label Review (Monograph Conformity)\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":67824343515213,"sku":null,"price":395.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/otc-drug-listing-with-fda-ndc-per-sku.webp?v=1793176385","url":"https:\/\/phoenixcosmeticsafety.com\/products\/otc-drug-listing-with-fda-ndc-per-sku","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}