FDA.reportPublic FDA data

Malin and Goetz

Product NDC
53634-010
11-digit product format
536340010
Labeler code
53634
Product ID
53634-010_401ba64a-bb2a-af37-e063-6394a90afb8a
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Malin and Goetz
Brand name suffix
Acne Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii70FD1KFU70

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53634-010-022024-10-30C16284748780-11030e365-2c80-111a-e063-dadaa90a10e2Acne treatment Nighttime
53634-010-022024-01-30C16284748780-11030e365-2c80-111a-e063-dadaa90a10e2Acne 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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU70MALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC]1
SULFURACTIVE MOIETY70FD1KFU70MALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC]1
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETMALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCMALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZMALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC]1
WATERINACTIVE INGREDIENT059QF0KO0RMALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZMALIN AND GOETZ ACNE TREATMENT (SULFUR,SALICYLIC ACID) CREAM [MALIN AND GOETZ INC]1

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

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