Treatment 101

Product NDC
51439-004
11-digit product format
514390004
Labeler code
51439
Product ID
51439-004_f8f84d20-59c6-4bc7-a048-71a35b22377c
Type
HUMAN OTC DRUG
Nonproprietary name
Sulphur
Dosage form
LIQUID
Route
TOPICAL
Labeler
CarePluss Pharma S.A. de C.V.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-08-06
Marketing end
0000-00-00
Substance
SULFUR
Active strength
0 mg/.06mg
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 productproduct51439-004IInactivated by FDA2026-10-16
excluded packagepackage51439-00451439-004-01IInactivated by FDA2026-10-16

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 NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51439-004-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51439-004-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51439-004-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51439-004-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51439-004-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51439-004-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51439-004-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51439-004-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51439-004-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51439-004-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51439-004-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51439-004-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51439-004-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51439-004-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51439-004-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51439-004-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51439-004-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51439-004-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51439-004-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51439-004-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51439-004-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51439-004-01110d247fa046…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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51439-004-012019-11-27C16284748780-19855d018-dd2d-cd31-e053-dbdaa90ab51a98807784-7c1f-4ec5-bf1e-d5748f62eced

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51439-004-01Treatment 101Acne Clearing Treatment.06 mg in 1 BOTTLELIQUID.062

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU70TREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
SULFURACTIVE MOIETY70FD1KFU70TREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZWTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
BROMELAINSINACTIVE INGREDIENTU182GP2CF3TREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
CATALINAINACTIVE INGREDIENTT3JI0587Q7TREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
CETEARETH-12INACTIVE INGREDIENT7V4MR24V5PTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
DODECYLBENZENESULFONIC ACIDINACTIVE INGREDIENT60NSK897G9TREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV0TREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
ETHYLENE GLYCOLINACTIVE INGREDIENTFC72KVT52FTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
MINTINACTIVE INGREDIENTFV98Z8GITPTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
PIPERINEINACTIVE INGREDIENTU71XL721QKTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2
WATERINACTIVE INGREDIENT059QF0KO0RTREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51439-004TREATMENT 101 ACNE CLEARING TREATMENT (SULPHUR) LIQUID [CAREPLUSS PHARMA S.A. DE C.V.]2Legacy NDC, 1 package rows20130320_98807784-7c1f-4ec5-bf1e-d5748f62eced.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282727sulfur 5 % Topical SolutionPSN98807784-7c1f-4ec5-bf1e-d5748f62eced2
282727sulfur 50 MG/ML Topical SolutionSCD98807784-7c1f-4ec5-bf1e-d5748f62eced2
282727sulfur 5 % Topical SolutionSY98807784-7c1f-4ec5-bf1e-d5748f62eced2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51439-004-0151439000401.06 mg in 1 BOTTLEHistorical