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 2 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DocosanolDOCOSANOLWALMART INC. (see also Equate)e06fd4cf-cd92-4cae-94b7-abab95e97ebd2025-12-29WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLFSA Store Inc. (Caring Mills)fe67f56e-4c35-40cb-8a75-174a873f29002025-12-29WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever BlisterDOCOSANOLH E B71b2bb18-4a48-42c2-b03a-dccf581a0d972025-12-29WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)5ecf678b-d08a-4082-9d01-4468865a94b22025-12-29WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLStrategic Sourcing Services LLC8a6bb379-bc3a-4ad2-9ecd-8fe1870873d82025-12-29WarningsName fallback
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLTARGET Corporationb332d558-bbe0-4d62-a51f-f07a228e6dca2025-12-29WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLWalgreens1500df4d-0c69-4590-a67f-d11edcccd90c2025-12-29WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLWALMART INC. (see also Equate)fe56bf08-1efd-4996-a276-06b6039085f32025-12-29WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLLeader/ Cardinal Health 110, Inc.ed18ecb7-70ce-4037-a738-6b159e364d622025-12-25WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
DOCOSANOLDOCOSANOLKROGER COMPANY16ae0976-2940-27ae-e063-6394a90a62e82025-12-11WarningsName fallback
brand name: DOCOSANOL
generic name: DOCOSANOL
Cold Sore TreatmentDOCOSANOLP & L Development, LLC20d2480b-44b5-499f-8670-01d6a4e4cb342025-12-05WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLUnited Natural Foods, Inc. dba UNFI7dd527af-878c-4150-86d0-69881b5e3f8f2025-11-17WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4286c19b-8c81-40f6-8d97-cfebba87c1742025-10-10WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLFamily Dollar (FAMILY WELLNESS)40297d6b-1096-467b-906c-7019598845662025-10-08WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
Cold Sore Fever Blister TreatmentDOCOSANOLTopco Associates65351744-0438-4416-ae1f-9169fc21d8132025-09-11WarningsName fallback
generic name: DOCOSANOL
DocosanolDOCOSANOLStrategic Sourcing Services LLC3faf583c-90d2-4620-93ea-d763191ab4522025-09-09WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
DocosanolDOCOSANOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)b62ee383-631a-4220-8dfd-48ec67bb0a632025-09-08WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
DocosanolDOCOSANOLEncube Ethicals, Inc.5b3137d3-c186-4c5d-89d2-ec5d1c3da8cd2025-09-08WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
DocosanolDOCOSANOLWALMART INC. (see also Equate)cb2c7675-8045-4c38-8479-7d819d8086642025-08-22WarningsName fallback
brand name: Docosanol
generic name: DOCOSANOL
DocosanolDOCOSANOLBest Choice (Valu Merchandisers Company)ea458b65-8144-4671-857a-33b19c453e052025-08-21WarningsName fallback
brand name: Docosanol
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