ASD 3-in-1

Product NDC
69541-001
11-digit product format
695410001
Labeler code
69541
Product ID
69541-001_96353da4-58df-4423-b37b-e4a8150dd349
Type
HUMAN OTC DRUG
Nonproprietary name
salicylic acid
Dosage form
GEL
Route
TOPICAL
Labeler
Almen Cosmetic Group AB
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-01-23
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
2 g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69541-001IInactivated by FDA2026-10-12
excluded packagepackage69541-00169541-001-01IInactivated by FDA2026-10-12

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69541-001-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69541-001-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69541-001-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69541-001-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69541-001-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69541-001-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69541-001-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69541-001-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69541-001-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69541-001-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69541-001-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69541-001-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69541-001-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69541-001-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69541-001-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69541-001-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69541-001-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69541-001-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69541-001-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69541-001-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69541-001-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69541-001-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69541-001-012020-01-31C16284748780-19d75b9d0-ddbf-f424-e053-dadaa90a57cea13d83cf-9fc5-4870-b80e-fcd4b0dfa4f7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69541-001-01ASD 3-in-115 g in 1 TUBEGEL151

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
ALLANTOININACTIVE INGREDIENT344S277G0ZASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEINACTIVE INGREDIENTFJ1H6M2JG9ASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
GLYCERYL LAURATEINACTIVE INGREDIENTY98611C087ASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
GLYCERYL OLEATEINACTIVE INGREDIENT4PC054V79PASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38SASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)INACTIVE INGREDIENTJ2S07SB0YLASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ4ASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4ASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
PHYTATE SODIUMINACTIVE INGREDIENT88496G1ERLASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
SQUALANEINACTIVE INGREDIENTGW89575KF9ASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8ASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
WATERINACTIVE INGREDIENT059QF0KO0RASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
WITCH HAZELINACTIVE INGREDIENT101I4J0U34ASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69541-001ASD 3-IN-1 (SALICYLIC ACID) GEL [ALMEN COSMETIC GROUP AB]1Legacy NDC, 1 package rows20150123_a13d83cf-9fc5-4870-b80e-fcd4b0dfa4f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSNa13d83cf-9fc5-4870-b80e-fcd4b0dfa4f71
346298salicylic acid 0.02 MG/MG Topical GelSCDa13d83cf-9fc5-4870-b80e-fcd4b0dfa4f71
346298salicylic acid 2 % Topical GelSYa13d83cf-9fc5-4870-b80e-fcd4b0dfa4f71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69541-001-016954100010115 g in 1 TUBE15 gHistorical