FDA.reportPublic FDA data

NDC 53634-010-01 - Malin and Goetz Acne Treatment

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
53634-010
Requested NDC
53634-010-01
Package NDCs from labels
53634-010-01, 53634-010-02
Manufacturer
Malin and Goetz Inc
Effective date
2026-10-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Malin and Goetz Acne Treatment - Malin and Goetz IncMalin and Goetz Inc2026-10-06HUMAN OTC DRUG LABEL

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 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

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

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 73 of 381 · 7,616 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadsISOPROPYL ALCOHOLALCOVE BRANDS4bad1fee-b4fe-c518-e063-6294a90a03182026-02-24WarningsExact identifier
unii: ND2M416302
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
unii: SOI2LOH54Z
SHISEIDO ULTIMATE SUN PROTECTOR MINERALTITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION5e31eee8-6532-47ea-99fc-22418791804b2026-02-23WarningsExact identifier
unii: SOI2LOH54Z
Zinc Oxide and MentholZINC OXIDE, MENTHOLAkron Formulations India Private Limited4b84556c-521f-eebd-e063-6394a90a8e1e2026-02-23WarningsExact identifier
unii: SOI2LOH54Z
Equate VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc3006971b-784c-43fd-91a6-d96876bbf1852026-02-23WarningsExact identifier
unii: 5TJD82A1ET
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOL4 Visions LLC4b87d4cc-163e-1432-e063-6294a90af4832026-02-23WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions LLC4b88008f-fe78-4b7e-e063-6294a90ab9ae2026-02-23WarningsExact identifier
unii: ND2M416302
Universal Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC183efdc2-cf3e-4f06-b292-0cfd097418b32026-02-23WarningsExact identifier
unii: ND2M416302
NeuroSootheCAMPHOR, MENTHOLBlue Heron Pharmaceuticals, LLCe3c21cdb-0027-486b-9b83-c1261c3e73a62026-02-23WarningsExact identifier
unii: 5TJD82A1ET
Eryfotona AgelessZINC OXIDEISDIN Corp.a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f2026-02-23WarningsExact identifier
unii: SOI2LOH54Z
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE 8% SULFUR 4%Aspen Medical LLC4ba94e96-b107-77fe-e063-6394a90aa9802026-02-21Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: SOI2LOH54Z
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Diaper RashZINC OXIDEMeijer, Inc.1b72f927-c2ae-4190-a035-5d7bb9f53c152026-02-19Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Beauty HydratingHOMOSALATE, ZINC OXIDEMeijer, Inc.69b72139-757f-476d-99d2-33f5524c41d22026-02-19Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Medicated Apricot ScrubSALICYLIC ACIDMeijer, Inc.3aeb4f0b-a8f7-4ed7-b320-45e5ba0c81752026-02-19Warnings, Adverse reactionsExact identifier
application number: M006
unii: O414PZ4LPZ
Baby Diaper RashZINC OXIDEMeijer, Inc.04bec667-a11e-42d2-a4b3-1416eebf1e8d2026-02-19Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
unii: SOI2LOH54Z
Acne CleanserBENZOYL PEROXIDEMeijer, Inc.932ee049-ab3d-4839-a655-772e5594f6e12026-02-19Warnings, Adverse reactionsExact identifier
application number: M006
PHARMA CLEAR SPOT TREATMENTSALICYLIC ACIDPHARMAGEL INTERNATIONAL INC24736409-b500-4aae-857e-1f4fb1760a152026-02-19WarningsExact identifier
application number: M006
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.