FDA.reportPublic FDA data

Renu Laboratories Acne Sulphur L

Product NDC
76348-450
11-digit product format
763480450
Labeler code
76348
Product ID
76348-450_4616a187-4faa-181d-e063-6294a90ae910
Type
HUMAN OTC DRUG
Nonproprietary name
Acne Sulfur Lotion
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Renu Laboratories, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-04-16
Substance
SULFUR
Active strength
1.4 g/14g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Renu Laboratories Acne Sulphur L
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR1.4 g/14g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii70FD1KFU70
Rxcui240725

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
76348-450-022025-12-16C16284748780-12cef2736-7299-d83d-e063-dadaa90ab31fSulfur Lotion
76348-450-022025-01-30C16284748780-12cef2736-7299-d83d-e063-dadaa90ab31fSulfur Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-450-02Renu Laboratories Acne Sulphur L56 g in 1 BOTTLE, GLASSSUSPENSION566

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU70RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]2
SULFURACTIVE MOIETY70FD1KFU70RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]2
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETRENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCRENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]2
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZRENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RRENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]2
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZRENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-450RENU LABORATORIES ACNE SULPHUR L (ACNE SULFUR LOTION) SUSPENSION [RENU LABORATORIES, INC.]5Current NDC, Legacy NDC, 1 package rows20220118_13de0e4c-b134-41c0-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240725sulfur 10 % Topical LotionPSN13de0e4c-b134-41c0-e054-00144ff88e886
240725sulfur 100 MG/ML Topical LotionSCD13de0e4c-b134-41c0-e054-00144ff88e886
240725sulfur 10 % Topical LotionSY13de0e4c-b134-41c0-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76348-450-027634804500256 g in 1 BOTTLE, GLASS (76348-450-02) 56 g2015-04-160000-00-00NoNoCurrent