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 3 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DocosanolDOCOSANOLPublix Super Markets Inc.2e0a3a85-8a89-9297-e063-6294a90a403b2025-07-15WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLChain Drug Consortium, LLC86406372-9e95-43b9-b275-5661141a085b2025-06-26WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLAAFES/Your Military Exchangesb056ad46-bf48-4468-8b65-9e80176b6c522025-05-08WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
DocosanolDOCOSANOLAlembic Pharmaceuticals Limiteda87a077d-9b0e-490d-b4ac-26c7045828db2025-05-08WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
DOCOSANOLDOCOSANOLH2-Pharma, LLCf0b3a78b-b14c-4869-ba3b-d04ffa62e1d52025-04-14WarningsName fallback
brand name: DOCOSANOL
generic name: DOCOSANOL
Cold Sore Treatment DocosanolDOCOSANOLBlistex Inc.bcdd51a9-210c-4d92-b67e-e3ac16c998122025-04-11WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLAAFES/Your Military Exchanges11272b21-295d-49b3-83bf-5f71899340c52025-03-07WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever BlisterDOCOSANOLP & L Development, LLCa71d2510-03c7-4724-b77b-12dd6451eb982025-01-03WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLThe Kroger Co.07fc9c8d-dee7-4a69-bb7a-0f3001a4ebb32024-10-17WarningsName fallback
generic name: DOCOSANOL
DOCOSANOLDOCOSANOLAmerisource Bergend6559957-0082-42b1-a43d-7c92cbd8b1a82024-10-01WarningsName fallback
brand name: DOCOSANOL
generic name: DOCOSANOL
DocosanolDOCOSANOLSafeway, Inc.d5ba34f8-42ab-4997-b06b-ea4e754b44d12024-08-21WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLSafeway, Inc.5871e578-d16e-4f07-a32e-5263f9ca0a6a2024-08-21WarningsName fallback
generic name: DOCOSANOL
Julie Cold Sore TreatmentDOCOSANOLJulie Products Inc113372a4-58de-f829-e063-6294a90a4eb12024-07-19WarningsName fallback
generic name: DOCOSANOL
ABREVADOCOSANOLHaleon US Holdings LLCc39b38a7-dcdd-4c32-8f35-b565c4d3cec62024-06-20WarningsName fallback
generic name: DOCOSANOL
ABREVADOCOSANOLHaleon US Holdings LLCbf02c8c5-af60-41f1-a202-38a97491a7202024-06-20WarningsName fallback
generic name: DOCOSANOL
DOCOSANOLDOCOSANOLRugby Laboratories6f8d6375-8188-42e9-a048-e8a554122ff32024-05-23WarningsName fallback
brand name: DOCOSANOL
generic name: DOCOSANOL
DOCOSANOLDOCOSANOLCosette Pharmaceuticals, Inc.ccbb5e6d-cb85-449c-a480-28225d744f4d2024-01-04WarningsName fallback
brand name: DOCOSANOL
generic name: DOCOSANOL
DocosanolDOCOSANOLAlembic Pharmaceuticals Inc.86450000-1810-4739-9801-59beb7c19e672023-12-22WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore TreatmentDOCOSANOLH E Ba94bc3d7-3bc5-4ed6-9bc9-46df1e2c3c2d2023-10-12WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever BlisterDOCOSANOLH E Bd9c5f237-62a2-4cba-920d-2c7aa0434b0e2023-10-12WarningsName 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