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 46 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 Daily Deep Cleansing Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc 74c49388-3314-47e8-80b1-19c09e6ea1f9 2024-07-14 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION 873de079-8b8d-45cd-8c7c-4645818f5aaa 2024-07-14 Warnings Exact identifier application number: M006 Dr. Zenovia Clear Complexion SALICYLIC ACID Topiderm, Inc. 4ff9b26d-3cd9-4539-b389-edd2df24a466 2024-06-28 Warnings Exact identifier application number: M006 LEROSETT Botanical Acne Cleanser SALICYLIC ACID GUNILLA OF SWEDEN, INC. 8b31d155-c257-4452-9e22-0c69fa36173e 2024-06-27 Warnings Exact identifier application number: M006 SkinCeuticals Silymarin CF Acne Treatment Antioxidant SALICYLIC ACID Cosmetique Active Production fcc3c44b-3090-45b5-91e4-e591c92a08c8 2024-06-24 Warnings Exact identifier application number: M006 Peace Out Early Stage Acne Dot SALICYLIC ACID Peace Out LLC. 0632d458-d326-ade4-e063-6294a90af3ba 2024-06-20 Warnings Exact identifier application number: M006 Replenix BP Acne BENZOYL PEROXIDE Topiderm, Inc. f449e020-a4d8-4a1b-82eb-4dc59e99b8d4 2024-06-18 Warnings Exact identifier application number: M006 b pure Pressed Powder for Acne Prone Skin Fair SALICYLIC ACID Fourstar Group USA, Inc. ecf22bd1-4fc3-4455-ae01-13f97f53dc34 2024-06-17 Warnings Exact identifier application number: M006 b pure Pressed Powder for Acne Prone Skin Tan SALICYLIC ACID Fourstar Group USA, Inc. 1158f6c2-2b59-4ed3-8d28-73b6da885a5d 2024-06-17 Warnings Exact identifier application number: M006 Gly-Sal 10-2 SALICYLIC ACID Topiderm, Inc. 661cc58b-9360-4b96-b405-afdc2e378397 2024-06-13 Warnings Exact identifier application number: M006 BLAIR and JACK Anti-Bump Acne Treatment BENZOYL PEROXIDE Blair + Jack aa8df86a-639c-4416-aadf-4b58566ed9f1 2024-06-11 Warnings Exact identifier application number: M006 b pure Blemish Concealer for Acne Prone Skin Nude SALICYLIC ACID Fourstar Group USA, Inc. 76e91277-1fb4-490b-b351-39d626bc1fc2 2024-06-11 Warnings Exact identifier application number: M006 b pure Blemish Concealer for Acne Prone Skin Fair SALICYLIC ACID Fourstar Group USA, Inc. 764599e5-2ec3-4223-819e-36415fd915f7 2024-06-11 Warnings Exact identifier application number: M006 Dr. Zenovia Acne Cleanser BENZOYL PEROXIDE Topiderm, Inc. 00fb1ee5-6076-4980-8507-9e58a96e6a6b 2024-06-11 Warnings Exact identifier application number: M006 Dr. Zenovia Spot Treatment BENZOYL PEROXIDE Topiderm, Inc. dfdb3d8e-4d39-4ce4-851f-80b11972ca9e 2024-06-11 Warnings Exact identifier application number: M006 Rugby Benzoyl Peroxide Acne Medication BENZOYL PEROXIDE NuCare Pharmaceuticals,Inc. 69bd4f4c-017a-7422-e053-2991aa0aa655 2024-06-10 Warnings Exact identifier application number: M006 Thayers Natural Remedies Since 1847 Rapid Acne Treatment SULFUR L'Oreal USA Products Inc d7cc3c06-2f89-4c0b-b121-fdd53638b625 2024-06-07 Warnings Exact identifier application number: M006 Differin 10% BPO Acne Treatment BENZOYL PEROXIDE Galderma Laboratories, L.P. 05468eab-f239-42cb-9106-055a105f0fa5 2024-06-06 Warnings Exact identifier application number: M006 2.5 Acne Med BENZOYL PEROXIDE Face Reality, Inc. 58a7f677-996c-4951-8e5d-b5556244f800 2024-06-05 Warnings Exact identifier application number: M006 10 Acne Med BENZOYL PEROXIDE Face Reality, Inc. 91791905-086f-44cf-9c1a-e9f132c6c11b 2024-06-05 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