FDA.reportPublic FDA data

Application 214613

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOCOSANOLDOCOSANOLCREAM;TOPICAL10%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214613-001DOCOSANOLDOCOSANOL10%CREAM / TOPICAL2025-10-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A214613-001DOCOSANOL10%CREAM / TOPICAL2025-10-0384e616aacf4f…
2026-08-18 06:07:402026-07A214613-001DOCOSANOL10%CREAM / TOPICAL2025-10-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214613-001DOCOSANOL10%CREAM / TOPICAL2025-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214613-001DOCOSANOL10%CREAM / TOPICAL2025-10-0331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214613-001DOCOSANOL10%CREAM / TOPICAL2025-10-03a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DocosanolDOCOSANOLCare One (Retail Business Services, LLC.)c3f386e2-68da-4d64-809a-e170d473731d2023-10-05WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
DOCOSANOLDOCOSANOLH2-Pharma, LLC48c029bd-c061-4228-b66f-a70a297185b72023-07-20WarningsName fallback
brand name: DOCOSANOL
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLMeijer Distribution Inc.f00f46a0-2746-4538-93b6-09930d9c110c2023-07-19WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLH E B98726ef3-ae48-4447-86de-17d37d2324cd2023-07-19WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)edeae56f-6061-45a7-a79d-845a603067992023-07-07WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLMEIJER, INC.3eb9cf4a-4be8-4648-b63c-2eb7377588cf2023-06-06WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLMeijer Distribution Inc.15c51055-2a07-4a0f-b140-89af34aa90db2023-06-06WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLFSA Store Inc. (Caring Mills)c17cc31f-bd2e-4da2-bba4-54b6b8b1ebf72022-12-01WarningsName fallback
generic name: DOCOSANOL
Cold Sore TreatmentDOCOSANOLFSA Store Inc. (Caring Mills)a46e4d60-e84b-44a9-9d54-4861dbe91c592022-12-01WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLCare One (Retail Business Services, LLC.)3587f8f0-99ab-4493-adde-0dfd0911170d2022-10-21WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore TreatmentDOCOSANOLP & L Development, LLC15d1a6c5-4a61-48f3-b45e-a7e34cbeb2942022-10-18WarningsName fallback
generic name: DOCOSANOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69842-880DocosanolDocosanolCVS Health CorpANDACurrent