Docosanol

Product NDC
41250-932
Requested package NDC
41250-932-07
11-digit product format
412500932
Labeler code
41250
Product ID
41250-932_8923f39c-9b99-4e31-8c1d-b93991b9d9e9
Type
HUMAN OTC DRUG
Nonproprietary name
Docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
MEIJER, INC.
Application
ANDA208754
Marketing category
ANDA
Marketing start
2020-04-01
Marketing end
0000-00-00
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41250-93241250-932-07DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41250-93241250-932-07DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41250-93241250-932-07DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A208754-001DOCOSANOLDOCOSANOL10%CREAM / TOPICAL2018-11-19

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-193f01610625f2…
2019-09-15 20:21 UTC2019-09A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208754-001DOCOSANOL10%CREAM / TOPICAL2018-11-19cb3db0bc1861…

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Sore Fever Blister TreatmentDOCOSANOLWalgreensac3280b7-00aa-46cd-84e2-0a11992028ab2026-07-09WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
Cold Sore Fever Blister TreatmentDOCOSANOLThe Kroger Co.42b46e02-4d1f-411e-be9e-227f62ba5a862026-06-23WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
Cold Sore Fever Blister TreatmentDOCOSANOLWALMART INC. (see also Equate)f283ffd8-860a-4e97-8e22-94b907f75c8d2026-04-29WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
Cold Sore Fever Blister TreatmentDOCOSANOLP & L Development, LLCe88e49b9-c292-48c5-b19e-630ffa6447e72026-04-02WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
DocosanolDOCOSANOLWALMART INC. (see also Equate)45cfa88b-8146-4349-99cc-beec704557092026-02-18WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
Cold Sore Fever Blister TreatmentDOCOSANOLTARGET Corporationf68bd51a-9166-47a1-81f7-e379a93ab8232026-01-22WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
Cold Sore Fever Blister TreatmentDOCOSANOLWalgreensa578c749-4264-4d5c-9357-ed482a04fb8b2026-01-15WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
Cold Sore Fever Blister TreatmentDOCOSANOLWalgreens73178cbc-21f8-4fc1-8d31-50601f10dbd42025-12-29WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
DocosanolDOCOSANOLWALMART INC. (see also Equate)e06fd4cf-cd92-4cae-94b7-abab95e97ebd2025-12-29WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
DocosanolDOCOSANOLUnited Natural Foods, Inc. dba UNFI7dd527af-878c-4150-86d0-69881b5e3f8f2025-11-17WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
Cold Sore Fever Blister TreatmentDOCOSANOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4286c19b-8c81-40f6-8d97-cfebba87c1742025-10-10WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
DocosanolDOCOSANOLFamily Dollar (FAMILY WELLNESS)40297d6b-1096-467b-906c-7019598845662025-10-08WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
Cold Sore Fever Blister TreatmentDOCOSANOLTopco Associates65351744-0438-4416-ae1f-9169fc21d8132025-09-11WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
DocosanolDOCOSANOLStrategic Sourcing Services LLC3faf583c-90d2-4620-93ea-d763191ab4522025-09-09WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
DocosanolDOCOSANOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)b62ee383-631a-4220-8dfd-48ec67bb0a632025-09-08WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
DocosanolDOCOSANOLWALMART INC. (see also Equate)cb2c7675-8045-4c38-8479-7d819d8086642025-08-22WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
DocosanolDOCOSANOLBest Choice (Valu Merchandisers Company)ea458b65-8144-4671-857a-33b19c453e052025-08-21WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
Cold Sore Fever Blister TreatmentDOCOSANOLChain Drug Consortium, LLC86406372-9e95-43b9-b275-5661141a085b2025-06-26WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
DocosanolDOCOSANOLAAFES/Your Military Exchangesb056ad46-bf48-4468-8b65-9e80176b6c522025-05-08WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754
Cold Sore Fever Blister TreatmentDOCOSANOLSafeway, Inc.5871e578-d16e-4f07-a32e-5263f9ca0a6a2024-08-21WarningsExact identifier
application applno (ANDA): 208754
application number: ANDA208754

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-932-07412500932071 TUBE in 1 PACKAGE (41250-932-07) > 2 g in 1 TUBE1 tube2020-04-010000-00-00NoNoCurrent