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 4 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERYNTH MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4c3bfa-32ec-c0dd-e063-6394a90ab15c2026-07-21WarningsExact identifier
application number: M006
OURUI ONE FACIAL BUMP REFINING ESSENCESALICYLIC ACID 0.25% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4959bb67-063f-ffa4-e063-6394a90aa01f2026-07-20WarningsExact identifier
application number: M006
Beilloso FACIAL BUMP REFINING ESSENCESALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4a461a7a-f5cf-6544-e063-6294a90a00f22026-07-20WarningsExact identifier
application number: M006
Lepnuns MILIA REMOVERDIDECYL DIMETHYL AMMONIUM CHLORIDE 0.025% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD497ed53c-2562-b370-e063-6294a90a5ba12026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Molecules, LLC44fa9eda-0910-7d70-e063-6394a90af3a72026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Moleculesdec189a2-5f93-7c3e-e053-2a95a90af9882026-07-20WarningsExact identifier
application number: M006
Clean and Clear Essentials Acne TonerSALICYLIC ACIDKenvue Brands LLC06cd03e3-6146-65d8-e063-6294a90a17012026-07-17WarningsExact identifier
application number: M006
24 Hour Acne SerumBENZOYL PEROXIDEDrmtlgy, LLC55507941-dbdf-4e5f-a74d-4da6f67b6a1f2026-07-17WarningsExact identifier
application number: M006
PCA Skin Acne Control Prebiotic CleanserSALICYLIC ACIDCP Skin Health Group, Inc.56bca675-3e59-815a-e063-6294a90a1d872026-07-16WarningsExact identifier
application number: M006
Acne patchesACNE PATCHESShenzhen Hengdasheng Technology Co., Ltd5664b9c4-6ae3-4f64-e063-6294a90a825a2026-07-14WarningsExact identifier
application number: M006
Zmztuhua Folliculitis Treatment CreamBENZOYL PEROXIDEGuangzhou Hechuang Commercial Service Co.,Ltd.567ceafc-b75a-9777-e063-6394a90ae1602026-07-13WarningsExact identifier
application number: M006
Magnilife Eczema CareSULFUR, GRAPHITE, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS WHOLEThe Magni Group, Inc.8e3fc743-4c82-4a03-a963-2d5f93a1bc262026-07-13WarningsExact identifier
application number: M006
PHYLA ACNE PHAGE SERUMSALICYLIC ACIDCOSMAX USA, CORP564abe82-c983-6a98-e063-6394a90a14a02026-07-10WarningsExact identifier
application number: M006
GOOD MOLECULE MAXIMUM STRENGHT ACNESALICYLIC ACIDCOSMAX USA, CORP564aafc0-1a06-1cba-e063-6294a90ae7382026-07-10WarningsExact identifier
application number: M006
Touch Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEDiractions Capital LLC1ae4e081-b04a-407d-992d-cd398f3afc542026-07-10WarningsExact identifier
application number: M006
Drs. ACNE SPOT TREATMENTSALICYLIC ACIDOL PHARMA TECH, LLC Drs. PHARMACY161b2306-364a-e1b8-e063-6394a90a6c882026-07-09WarningsExact identifier
application number: M006
Proactiv Acne Body WashSALICYLIC ACIDAlchemee, LLC36aef223-6a4a-433f-b292-631e6068b17f2026-07-08WarningsExact identifier
application number: M006
LadovernaBENZOYL PEROXIDE CREAMGuangzhou Oupeng Cosmetics Co., Ltd.55b0f9fd-9055-6969-e063-6294a90a1a7d2026-07-07WarningsExact identifier
application number: M006
L BRI KlearawaySALICYLIC ACIDL'BRI Health & Beautyb9aa1c48-b767-47b0-bb98-efb7e860ab362026-07-06WarningsExact identifier
application number: M006
L BRI Deep Clean TonerSALICYLIC ACIDL'BRI Health & Beauty607fb6d0-ae49-472c-9224-0673af934bd22026-07-06WarningsExact 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