Home NDC 53634-010 Malin and Goetz
Product NDC 53634-010
11-digit product format 536340010
Labeler code 53634
Product ID 53634-010_5d34805a-103b-89b9-e063-6394a90acf5d
Type HUMAN OTC DRUG
Nonproprietary name sulfur
Dosage form CREAM
Route TOPICAL
Labeler Malin and Goetz Inc
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-11-05
Substance SULFUR
Active strength 10 g/100mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53634-010-02 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53634-010-02 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53634-010-02 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53634-010-02 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53634-010-02 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Malin and Goetz
Brand name suffix Acne Treatment
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFUR 10 g/100mL
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53634-010-01 Malin and GoetzAcne Treatment 14.75 mL in 1 JAR CREAM 14.75 7 53634-010-02 Malin and GoetzAcne Treatment 1 in 1 CARTON CREAM 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFUR ACTIVE INGREDIENT 70FD1KFU70 MALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC] 1 SULFUR ACTIVE MOIETY 70FD1KFU70 MALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC] 1 CAMPHOR (SYNTHETIC) INACTIVE INGREDIENT 5TJD82A1ET MALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 MALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC] 1 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC MALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC] 1 SALICYLIC ACID INACTIVE INGREDIENT O414PZ4LPZ MALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R MALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC] 1 ZINC OXIDE INACTIVE INGREDIENT SOI2LOH54Z MALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53634-010 MALIN AND GOETZ ACNE TREATMENT (SULFUR) CREAM [MALIN AND GOETZ INC] 6 Current NDC, Legacy NDC, 2 package rows 20241101_47390813-6bc9-44f4-b72a-d399d2c0de27.zip
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vichy Laboratoires Normaderm SOS Acne Rescue Spot Corrector SULFUR L'Oreal USA Products Inc 4907bc52-62e3-4256-b4ca-bcde896a4aab 2023-12-27 Warnings Exact identifier application number: M006 Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Pads SALICYLIC ACID L'Oreal USA Products Inc bc0d1691-c13d-4c15-8c44-ecee30cb0ae2 2023-12-27 Warnings Exact identifier application number: M006 Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Cleanser SALICYLIC ACID L'Oreal USA Products Inc 935a58f0-d9a3-4423-9a5f-65fd19fad3db 2023-12-27 Warnings Exact identifier application number: M006 All Acne Treatment SALICYLIC ACID Blaine Labs Inc. ee85939e-64fc-4b18-af5b-6ebd7e14e572 2023-12-21 Warnings Exact identifier application number: M006 In the Clear Acne Serum SALICYLIC ACID The Honest Company, Inc dc9e0545-43af-3d27-e053-2a95a90a5249 2023-12-19 Warnings Exact identifier application number: M006 Spot Stopper Acne Spot Treatment SALICYLIC ACID The Honest Company, Inc dc7afebd-e212-b9ff-e053-2a95a90a15a5 2023-12-19 Warnings Exact identifier application number: M006 Get Clarity Foaming Acne Cleanser SULFUR The Honest Company, Inc dd948b1b-d71c-1a89-e053-2a95a90a8719 2023-12-19 Warnings Exact identifier application number: M006 Acne Med 10% BENZOYL PEROXIDE Face Reality, LLC 45ad7429-ccd0-28f6-e054-00144ff88e88 2023-12-15 Warnings Exact identifier application number: M006 Acne Face and Body BENZOYL PEROXIDE Face Reality, Inc. 454983d2-4b00-6268-e054-00144ff8d46c 2023-12-15 Warnings Exact identifier application number: M006 Acne Med 5% BENZOYL PEROXIDE Face Reality, LLC 454983d2-4b11-6268-e054-00144ff8d46c 2023-12-15 Warnings Exact identifier application number: M006 Acne Face and Body Wash BENZOYL PEROXIDE Face Reality Skin Care, LLC 454983d2-4aec-6268-e054-00144ff8d46c 2023-12-15 Warnings Exact identifier application number: M006 Acne Med 2.5% BENZOYL PEROXIDE Face Reality, LLC 454983d2-4b0f-6268-e054-00144ff8d46c 2023-12-15 Warnings Exact identifier application number: M006 Nighttime Control BENZOYL PEROXIDE Circadia by Dr Pugliese, Inc. fb4cc832-4cfd-4e29-a78e-ab848681a224 2023-12-15 Warnings Exact identifier application number: M006 La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc 5056320e-e472-44ed-9afd-759ba55f0fd7 2023-12-13 Warnings Exact identifier application number: M006 La Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne Treatment SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION 418d480c-4131-4262-bb56-d5b10bbf7dcb 2023-12-13 Warnings Exact identifier application number: M006 Acne Advanced Clarifying Masque SALICYLIC ACID Eminence Organic Skin Care Ltd. 7916a299-fc90-4eb7-882f-4caa39e2c7aa 2023-12-12 Warnings Exact identifier application number: M006 Serious Skincare Continuously Clear Acne Medication For Problematic skin Dry Lo Pro All- Over Treatment SALICYLIC ACID Flageoli Limited eb57517c-cf9e-4272-9c00-380385f916e0 2023-12-12 Warnings Exact identifier application number: M006 111MedCo 6% Sulfur Skin Cleansing Bar SULFUR 111MedCo LLC 7a2d647f-f10f-4637-b28b-319fed93677b 2023-12-12 Warnings Exact identifier application number: M006 111MedCo 2% Salicylic Acid Cleansing Bar SALICYLIC ACID 111MedCo LLC 6ba7dd8f-b59f-4dfb-b55e-c7fe65a54d8a 2023-12-12 Warnings Exact identifier application number: M006 111 Medco Benzoyl Peroxide BENZOYL PEROXIDE 111 Medco 8590214e-e5a7-8934-e053-2a91aa0a248b 2023-12-12 Warnings Exact identifier application number: M006
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53634-010-01 53634001001 14.75 mL in 1 JAR 14.75 ml Historical 53634-010-02 53634001002 1 JAR in 1 CARTON (53634-010-02) / 14.75 mL in 1 JAR (53634-010-01) 1 jar 2012-11-05 0000-00-00 No No Current