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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53634-010-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53634-010-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53634-010-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53634-010-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53634-010-021332a3947898…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
IngredientStrength
SULFUR10 g/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-10-30Acne treatment Nighttime
2024-10-30Acne treatment Nighttime
2024-01-30Acne treatment Nighttime
2024-01-30Acne treatment Nighttime

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53634-010-01Malin and GoetzAcne Treatment14.75 mL in 1 JARCREAM14.757
53634-010-02Malin and GoetzAcne Treatment1 in 1 CARTONCREAM17

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53634-010MALIN AND GOETZ ACNE TREATMENT (SULFUR) CREAM [MALIN AND GOETZ INC]6Current NDC, Legacy NDC, 2 package rows20241101_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 5 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
10% Azelaic AcidAZELAIC ACID CREAMGuangzhou Ariel Medical Technology Co., Ltd.55b03daa-b6d4-9edf-e063-6394a90ac4d12026-07-03WarningsExact identifier
application number: M006
Hero Mighty CleanserSALICYLIC ACIDChurch & Dwight Co., Inc.5597df54-2e58-0d6a-e063-6394a90a16972026-07-01WarningsExact identifier
application number: M006
Hero Pore CleanserSALICYLIC ACIDChurch & Dwight Co., Inc.559987c0-7abe-13fc-e063-6294a90a9f272026-07-01WarningsExact identifier
application number: M006
Acne Treatment Cream2% SALICYLIC ACIDZytrell Skin Solutions Inc.555be487-92d8-6220-e063-6394a90a0c0a2026-06-28WarningsExact identifier
application number: M006
SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENTSALICYLIC ACIDLongway Technology(Guangzhou)Co., Ltd.553957ef-cb8a-e75d-e063-6394a90a261b2026-06-27WarningsExact identifier
application number: M006
ORLASKIN ACNE TreatmentSALICYLIC ACIDGuangzhou Yapheon Health Industry Co., Ltd.552bf5df-0a3c-7c10-e063-6394a90a311f2026-06-26WarningsExact identifier
application number: M006
ORLASKIN SALICYLIC ACID ACNE TREATMENT PADSSALICYLIC ACIDGuangzhou Yapheon Health Industry Co., Ltd.552c9e72-db4b-641a-e063-6294a90a29012026-06-26WarningsExact identifier
application number: M006
CosmoClear CleanserSALICYLIC ACIDNoon Aesthetics M.R. Ltddd738dfd-676b-40fe-8b0e-3d8305e0fdcb2026-06-25WarningsExact identifier
application number: M006
Walgreens Acne Foaming CleanserBENZOYL PEROXIDEWALGREEN COMPANY549fddb8-9d42-16cb-e063-6294a90aa2a92026-06-19WarningsExact identifier
application number: M006
Walgreens Maximum Strength Acne TreatmentBENZOYL PEROXIDEWALGREEN COMPANY548e327b-1a4f-03df-e063-6294a90a39322026-06-18WarningsExact identifier
application number: M006
EpochSALICYLIC ACIDNSE Products, Inc.3084ac37-de1f-4218-9471-6a5ebf720eb92026-06-17WarningsExact identifier
application number: M006
VICHY LABORATOIRES NORMADERM ACNE CONTROL DAILY MOISTURIZERSALICYLIC ACIDLOreal USA Products Inc17b7a58b-97f2-429f-83cb-db04631d307d2026-06-16WarningsExact identifier
application number: M006
VICHY LABORATOIRES NORMADERM ACNE CONTROL DAILY MOISTURIZERSALICYLIC ACIDCosmetique Active Production17b8a58b-97f2-429f-83cb-db04631d307d2026-06-16WarningsExact identifier
application number: M006
Societe Clarity BacSALICYLIC ACIDSociete Clinical Skincare545130ce-46f9-c231-e063-6394a90a1ea82026-06-16WarningsExact identifier
application number: M006
ES Salicylic WashSALICYLIC ACIDElaine Sterling Enterprises543ab052-5aa9-6585-e063-6394a90af88f2026-06-16WarningsExact identifier
application number: M006
Societe Clear Skin PadsSALICYLIC ACIDSociete Clinical Skincare543a4347-d7d8-3050-e063-6294a90ab3a22026-06-16WarningsExact identifier
application number: M006
FHF Crisp StartACNE CLEANSERSummer Soles LLC dba Farmhouse Fresh Goods54391292-263d-253e-e063-6394a90a742f2026-06-16WarningsExact identifier
application number: M006
FHF Change Peel PadsSALICYLIC PADSSummer Soles, LLC dba Farmhouse Fresh Goods5439a9dd-786c-9140-e063-6394a90a8fa92026-06-16WarningsExact identifier
application number: M006
FHF Day BreakthruSALICYLIC SERUMSummer Doles dba Farmhouse Fresh Fresh Goods54397bb7-1845-72a7-e063-6394a90abbd12026-06-16WarningsExact identifier
application number: M006
Societe Daily ExfoliationSALICYLIC ACIDSociete Clinical Skincare54633a24-3761-14d7-e063-6294a90a89f92026-06-16WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53634-010-015363400100114.75 mL in 1 JAR14.75 mlHistorical
53634-010-02536340010021 JAR in 1 CARTON (53634-010-02) / 14.75 mL in 1 JAR (53634-010-01) 1 jar2012-11-050000-00-00NoNoCurrent