ACNEFREE THERAPEUTIC SULFUR MASK

Product NDC
0187-1619
11-digit product format
001871619
Labeler code
0187
Product ID
0187-1619_3268a857-838b-4492-84e4-386674303509
Type
HUMAN OTC DRUG
Nonproprietary name
SULFUR
Dosage form
CREAM
Route
TOPICAL
Labeler
Valeant Pharmaceuticals North America LLC
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-09-09
Marketing end
0000-00-00
Substance
SULFUR
Active strength
35 g/g
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 productproduct0187-1619DDiscontinued by firm2026-08-17
excluded packagepackage0187-16190187-1619-02DDiscontinued by firm2026-08-17

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 · 30 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0187-1619-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0187-1619-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0187-1619-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0187-1619-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0187-1619-02DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0187-1619-02DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0187-1619-02DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0187-1619-02DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0187-1619-02DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0187-1619-02DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0187-1619-02DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0187-1619-02DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0187-1619-02IInactivated 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 packagepackage0187-1619-02IInactivated 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 packagepackage0187-1619-02EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0187-1619-022021-05-10C16284748780-19d75b9d0-4e67-f424-e053-dadaa90a57ceDrug Facts
0187-1619-022020-01-31C16284748780-19d75b9d0-4e67-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU70ACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
SULFURACTIVE MOIETY70FD1KFU70ACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
ACACIAINACTIVE INGREDIENT5C5403N26OACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
COPPER GLUCONATEINACTIVE INGREDIENTRV823G6G67ACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
KAOLININACTIVE INGREDIENT24H4NWX5COACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
MAGNESIUM ASPARTATEINACTIVE INGREDIENTR17X820ROLACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7IACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
SODIUM COCOYL ISETHIONATEINACTIVE INGREDIENT518XTE8493ACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
ZINC GLUCONATEINACTIVE INGREDIENTU6WSN5SQ1ZACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
ZINC PIDOLATEINACTIVE INGREDIENTC32PQ86DH4ACNEFREE THERAPEUTIC SULFUR MASK (SULFUR) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3