FDA.reportPublic FDA data

Sulfur

Product NDC
68437-010
11-digit product format
684370010
Labeler code
68437
Product ID
68437-010_eb0475c6-c759-55a1-e053-2a95a90a69e9
Type
HUMAN OTC DRUG
Nonproprietary name
Sulfur
Dosage form
OINTMENT
Route
TOPICAL
Labeler
GRISI Hnos, S.A DE C.V
Application
M006
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-12-01
Marketing end
0000-00-00
Substance
SULFUR
Active strength
10 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct68437-010UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68437-01068437-010-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU70SULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
SULFURACTIVE MOIETY70FD1KFU70SULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWSULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
LANOLININACTIVE INGREDIENT7EV65EAW6HSULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HESULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ASULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVSULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
SORBITAN MONOPALMITATEINACTIVE INGREDIENT77K6Z421KUSULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2
WATERINACTIVE INGREDIENT059QF0KO0RSULFUR OINTMENT [GRISI HNOS, S.A DE C.V]2

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 20 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaharmony 10% SulfurSULFURD3 Development, Inc.c78ead80-a8ee-0b52-e053-2a95a90ab8802025-12-01WarningsExact identifier
application number: M006
Dermaharmony 10% Sulfur with Tea Tree OilSULFURD3 Development, Inc.c79005d4-0c6f-75d0-e053-2995a90a83142025-12-01WarningsExact identifier
application number: M006
Resurfacing acne swipesSALICYLIC ACIDOars And Alps LLCefe14f46-c947-aea4-e053-2a95a90aad5f2025-12-01WarningsExact identifier
application number: M006
EradiKate ACNE TREATMENTSULFURRare Beauty Brands Inc44ebacf3-52c1-4896-e063-6394a90ac4472025-12-01WarningsExact identifier
application number: M006
EradiKate Daily Foaming Cleanser Acne TreatmentSULFURRare Beauty Brands Inc.44ebc725-796f-71e6-e063-6294a90a69a62025-12-01WarningsExact identifier
application number: M006
ERADIKATE ACNE MARK FADINGSALICYLIC ACIDRare Beauty Brands Inc.44ebe505-1ce8-88cf-e063-6394a90a4baf2025-12-01WarningsExact identifier
application number: M006
Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAsAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEGuthy-Renker,LLC76298090-e873-4307-8bdb-19cdab6d9ac22025-12-01WarningsExact identifier
application number: M006
Asepxia Baking Soda Acne BarSALICYLIC ACIDGenomma Lab USAded9fe59-9477-4425-8bbb-f9a49118f0042025-12-01WarningsExact identifier
application number: M006
Blemish Buster Solution Acne TreatmentSULFURGuthy-Renker LLCd2b9462d-7897-40a4-9022-eeb04e7d5adf2025-12-01WarningsExact identifier
application number: M006
Anna Guanche MD Miracle Cream The Pimple CreamSULFURBella Cosmeceuticals, Inc.b4562cf4-aae3-e9db-e053-2995a90a72102025-11-30WarningsExact identifier
application number: M006
Vanishing SkincareVANISHING DRY SERUM MASK, PHASE 3Vanish Skincare LLC27f19c03-1a18-6c74-e063-6394a90a6e862025-11-28WarningsExact identifier
application number: M006
OUHOE CLEARFACE Overnight AcneSALICYLIC ACIDShantou Ouhoe Technology Co., Ltd.2be1e888-e0a4-7db7-e063-6294a90a77d52025-11-27WarningsExact identifier
application number: M006
EELHOE AcneSALICYLIC ACIDShantou Eelhoe Daily Chemical Technology Co., Ltd.2a88a374-64bc-02a3-e063-6294a90a333e2025-11-27WarningsExact identifier
application number: M006
EELHOE Mole Reduce EssenceSALICYLIC ACIDShantou Eelhoe Daily Chemical Technology Co., Ltd.2f80ffc4-c945-71c9-e063-6394a90add8c2025-11-27WarningsExact identifier
application number: M006
JAYSUING ACNE PATCHESSALICYLIC ACIDShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.29fb7bcc-a630-1fba-e063-6294a90a65c12025-11-27WarningsExact identifier
application number: M006
ReliefCOLLOIDAL OATMEAL 1%Era Organics, Inc.0ad58a99-e41a-a830-e063-6294a90af9cb2025-11-27WarningsExact identifier
application number: M006
SuperbalmCOLLOIDAL OATMEAL 1%Era Organics, Inc.f5298e5e-583d-d74c-e053-2995a90affb52025-11-27WarningsExact identifier
application number: M006
OGEE CLEARGANICS TARGETED BLEMISH TREATMENTSALICYLIC ACID ACNE MEDICATIONOgee Inc162831d3-7e95-62f4-e063-6394a90aef7c2025-11-26WarningsExact identifier
application number: M006
EELHOE Pimple PatchesSALICYLIC ACIDShantou Ximonth Biotechnology Co., Ltd.ffd4972a-f9bd-44a4-9d29-cd57226968052025-11-26WarningsExact identifier
application number: M006
OUHOE PIMPLESALICYLIC ACIDShantou Woodsleep Biotechnology Co., Ltd.2a374e1c-0d21-e16c-e063-6394a90ab4872025-11-26WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68437-010-01684370010011 TUBE in 1 CARTON (68437-010-01) > 20 g in 1 TUBE (68437-010-20) 1 tube2012-12-010000-00-00NoNoCurrent