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 50 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vichy Laboratoires Normaderm SOS Acne Rescue Spot CorrectorSULFURL'Oreal USA Products Inc4907bc52-62e3-4256-b4ca-bcde896a4aab2023-12-27WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula PadsSALICYLIC ACIDL'Oreal USA Products Incbc0d1691-c13d-4c15-8c44-ecee30cb0ae22023-12-27WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula CleanserSALICYLIC ACIDL'Oreal USA Products Inc935a58f0-d9a3-4423-9a5f-65fd19fad3db2023-12-27WarningsExact identifier
application number: M006
All Acne TreatmentSALICYLIC ACIDBlaine Labs Inc.ee85939e-64fc-4b18-af5b-6ebd7e14e5722023-12-21WarningsExact identifier
application number: M006
In the Clear Acne SerumSALICYLIC ACIDThe Honest Company, Incdc9e0545-43af-3d27-e053-2a95a90a52492023-12-19WarningsExact identifier
application number: M006
Spot Stopper Acne Spot TreatmentSALICYLIC ACIDThe Honest Company, Incdc7afebd-e212-b9ff-e053-2a95a90a15a52023-12-19WarningsExact identifier
application number: M006
Get Clarity Foaming Acne CleanserSULFURThe Honest Company, Incdd948b1b-d71c-1a89-e053-2a95a90a87192023-12-19WarningsExact identifier
application number: M006
Acne Med 10%BENZOYL PEROXIDEFace Reality, LLC45ad7429-ccd0-28f6-e054-00144ff88e882023-12-15WarningsExact identifier
application number: M006
Acne Face and BodyBENZOYL PEROXIDEFace Reality, Inc.454983d2-4b00-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Acne Med 5%BENZOYL PEROXIDEFace Reality, LLC454983d2-4b11-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Acne Face and Body WashBENZOYL PEROXIDEFace Reality Skin Care, LLC454983d2-4aec-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Acne Med 2.5%BENZOYL PEROXIDEFace Reality, LLC454983d2-4b0f-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006
Nighttime ControlBENZOYL PEROXIDECircadia by Dr Pugliese, Inc.fb4cc832-4cfd-4e29-a78e-ab848681a2242023-12-15WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc5056320e-e472-44ed-9afd-759ba55f0fd72023-12-13WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION418d480c-4131-4262-bb56-d5b10bbf7dcb2023-12-13WarningsExact identifier
application number: M006
Acne Advanced Clarifying MasqueSALICYLIC ACIDEminence Organic Skin Care Ltd.7916a299-fc90-4eb7-882f-4caa39e2c7aa2023-12-12WarningsExact identifier
application number: M006
Serious Skincare Continuously Clear Acne Medication For Problematic skin Dry Lo Pro All- Over TreatmentSALICYLIC ACIDFlageoli Limitedeb57517c-cf9e-4272-9c00-380385f916e02023-12-12WarningsExact identifier
application number: M006
111MedCo 6% Sulfur Skin Cleansing BarSULFUR111MedCo LLC7a2d647f-f10f-4637-b28b-319fed93677b2023-12-12WarningsExact identifier
application number: M006
111MedCo 2% Salicylic Acid Cleansing BarSALICYLIC ACID111MedCo LLC6ba7dd8f-b59f-4dfb-b55e-c7fe65a54d8a2023-12-12WarningsExact identifier
application number: M006
111 Medco Benzoyl PeroxideBENZOYL PEROXIDE111 Medco8590214e-e5a7-8934-e053-2a91aa0a248b2023-12-12WarningsExact 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