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 3 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acne Free Free 24 HR Acne Clearing System BENZOYL PEROXIDE AcneFree, LLC c939847a-72eb-96fa-e053-2a95a90a4f9c 2026-07-31 Warnings Exact identifier application number: M006 Terminator 10 BENZOYL PEROXIDE AcneFree, LLC c06778b6-0ed6-7d82-e053-2a95a90a2ef8 2026-07-31 Warnings Exact identifier application number: M006 Acne Free Oil Free Acne Cleanser 2.5 Benzoyl Peroxide BENZOYL PEROXIDE AcneFree LLC c939847a-72cc-96fa-e053-2a95a90a4f9c 2026-07-31 Warnings Exact identifier application number: M006 Benzoyl Peroxide Deep Cleansing Foaming Wash BENZOYL PEROXIDE AcneFree, LLC fe2d0e24-8c68-b2ea-e053-6294a90ad72c 2026-07-31 Warnings Exact identifier application number: M006 Salicylic Acid SALICYLIC ACID Acne Free, LLC 1097fc73-fa47-0f14-e063-6294a90aa499 2026-07-31 Warnings Exact identifier application number: M006 Even and Clear Cleanser SALICYLIC ACID Ambi Enterprises LLC bff537cf-aa79-5250-e053-2995a90a388a 2026-07-31 Warnings Exact identifier application number: M006 Oil Free Deep Cleansing Duo Cleansing Brush Oil Free Acne Cleanser BENZOYL PEROXIDE AcneFree, LLC c7a675fa-b6c0-6237-e053-2a95a90a0406 2026-07-31 Warnings Exact identifier application number: M006 Acne Free SEVERE ACNE 24 HR Acne Clearing System BENZOYL PEROXIDE AcneFree, LLC c939681e-ea93-31ce-e053-2a95a90a8c70 2026-07-31 Warnings Exact identifier application number: M006 Acne Free SENSITIVE SKIN 24 HR Acne Clearing System SALICYLIC ACID, BENZOYL PEROXIDE AcneFree LLC c9397a25-8fed-48d0-e053-2a95a90ab495 2026-07-31 Warnings Exact identifier application number: M006 sulfur acne treatment SULFUR Acne Free 105545d8-974c-5a9a-e063-6294a90aecc4 2026-07-31 Warnings Exact identifier application number: M006 24 Hour Sensitive Skin Acne Clearing System SALICYLIC ACID Acne Free LLC 39ea674d-ff6e-a8c6-e063-6394a90a0656 2026-07-31 Warnings Exact identifier application number: M006 cardae FOLLICULITIS Cream MICONAZOLE NITRATE 2% FOLLICULITIS CREAM Wenzhou Yuyuan Pharmaceutical Co., Ltd. 57e0be6a-3141-f3b6-e063-6394a90a1520 2026-07-30 Warnings Exact identifier application number: M006 SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENT SALICYLIC ACID Gold Inti Trade Corporation 57a7c929-31f5-ef82-e063-6394a90ab9af 2026-07-28 Warnings Exact identifier application number: M006 Acne Treatment with Sulfur SULFUR DLC Laboratories, Inc. 4a1591e8-6135-4b22-b54c-5553c2dc0540 2026-07-28 Warnings Exact identifier application number: M006 amberglow BLEMISH PATCHES SALICYLIC ACID Pearl World Inc. 12054430-25ff-4b72-8f64-822b27abb443 2026-07-27 Warnings Exact identifier application number: M006 RFA BPO Acne Treatment 2.5% BENZOYL PEROXIDE Topiderm, Inc. c5053e9e-7608-45d9-9b9b-9b93210eb917 2026-07-27 Warnings Exact identifier application number: M006 ACNO Solution ACNE TREATMENT SALICYLIC ACID Noon Aesthetics M.R. Ltd 4a267e44-03d9-471f-9708-a5c60ff69097 2026-07-24 Warnings Exact identifier application number: M006 DERMFREE MILIA REMOVER SALICYLIC ACID 1% MILIA REMOVER Jiangxi Yudexi Pharmaceutical Co., LTD 4a5c8a6e-b02d-3a87-e063-6294a90a14ff 2026-07-23 Warnings Exact identifier application number: M006 salicylic acid SALICYLIC ACID Chain Drug Marketing Association 4dc96074-50a1-baa8-e063-6294a90a5aab 2026-07-22 Warnings, Adverse reactions Exact identifier application number: M006 SYLVIRENE MILIA REMOVER SALICYLIC ACID 1% MILIA REMOVER Jiangxi Yudexi Pharmaceutical Co., LTD 4a3751f8-2365-1b34-e063-6394a90acf74 2026-07-21 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