FDA.reportPublic FDA data

Application 215505

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 1.

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
A215505-001DOCOSANOLDOCOSANOL10%CREAM / TOPICAL2025-10-23

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
2026-02-19 14:30 UTC2026-02A215505-001DOCOSANOL10%CREAM / TOPICAL2025-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215505-001DOCOSANOL10%CREAM / TOPICAL2025-10-2331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215505-001DOCOSANOL10%CREAM / TOPICAL2025-10-23a50c72e98297…

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 1 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Sore Fever Blister TreatmentDOCOSANOLWalgreensac3280b7-00aa-46cd-84e2-0a11992028ab2026-08-06WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLYYBA Corp289e5003-7d08-c141-e063-6394a90abca32026-07-20WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLSportpharm LLCe3e6c0b0-399f-41e4-9df9-109ee29179952026-07-12WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLWalgreens518bd432-f0d0-4fc4-944c-b9d1a01e20642026-07-09WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLThe Kroger Co.42b46e02-4d1f-411e-be9e-227f62ba5a862026-06-23WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLSun Pharmaceutical Industries, Inc.5079b009-7f34-4d34-8f01-821365f04ca22026-06-19WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
DOCOSANOLDOCOSANOLAurohealth LLC9f361f24-a0a1-4e43-a158-8c830c9adca72026-06-10WarningsName fallback
brand name: DOCOSANOL
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLWALMART INC. (see also Equate)f283ffd8-860a-4e97-8e22-94b907f75c8d2026-04-29WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLP & L Development, LLCe88e49b9-c292-48c5-b19e-630ffa6447e72026-04-02WarningsName fallback
generic name: DOCOSANOL
AMAZON BASICS DOCOSANOLDOCOSANOLAmazon.com Services LLC3c28a462-c6d6-70ba-e063-6394a90ae8f32026-03-18WarningsName fallback
generic name: DOCOSANOL
DOCOSANOLDOCOSANOLCVS Pharmacy, Inc.336b515c-5e7b-4ece-a94f-f8d8e9ce6a7b2026-03-13WarningsName fallback
brand name: DOCOSANOL
generic name: DOCOSANOL
DocosanolDOCOSANOLWALMART INC. (see also Equate)45cfa88b-8146-4349-99cc-beec704557092026-02-18WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLTARGET Corporationf68bd51a-9166-47a1-81f7-e379a93ab8232026-01-22WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLWalgreensa578c749-4264-4d5c-9357-ed482a04fb8b2026-01-15WarningsName fallback
generic name: DOCOSANOL
Cold Sore TreatmentDOCOSANOLP & L Development, LLC53cd18dc-bece-473e-a116-df6c88fe6fe72025-12-29WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLTopco Associates73348ce7-5b08-49ad-ba59-6f54887f819b2025-12-29WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLWalgreens73178cbc-21f8-4fc1-8d31-50601f10dbd42025-12-29WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLCare One (Retail Business Services, LLC.)9f31b742-4170-4219-80e3-2a5a71b3483e2025-12-29WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLSafeway, Inc.85bfd33e-9404-4483-b76c-0ee519aad7312025-12-29WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLWALMART INC. (see also Equate)e06fd4cf-cd92-4cae-94b7-abab95e97ebd2025-12-29WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL