FDA.reportPublic FDA data

Balmex Diaper Rash

Product NDC
52412-285
11-digit product format
524120285
Labeler code
52412
Product ID
52412-285_29577ef9-f215-1dc6-e063-6394a90a44ab
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide 11.3%
Dosage form
CREAM
Route
TOPICAL
Labeler
Randob Labs, LTD
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-19
Substance
ZINC OXIDE
Active strength
11.3 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Balmex Diaper Rash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE11.3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
630923Internal RxNorm lookup
967558Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7f7a89d-d4e0-9faa-e053-6294a90aaf7bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52412-285-02Balmex Diaper Rash1 in 1 CARTONCREAM13
52412-285-02Balmex Diaper Rash56 g in 1 TUBECREAM563
52412-285-03Balmex Diaper Rash85 g in 1 TUBECREAM853
52412-285-03Balmex Diaper Rash1 in 1 CARTONCREAM13
52412-285-04Balmex Diaper Rash1 in 1 CARTONCREAM13
52412-285-04Balmex Diaper Rash113 g in 1 TUBECREAM1133
52412-285-12Balmex Diaper Rash340 g in 1 JARCREAM3403
52412-285-16Balmex Diaper Rash453 g in 1 JARCREAM4533

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-285BALMEX DIAPER RASH (ZINC OXIDE 11.3%) CREAM [RANDOB LABS, LTD]3Current NDC, 8 package rows20241217_f7f7a89d-d4e0-9faa-e053-6294a90aaf7b.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 3 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DawnMist White PetrolatumWHITE PETROLATUMDukal LLC598e9d46-6450-af60-e063-6394a90a3a6b2026-08-21WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
application number: M016
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
application number: M016
Earths Care Hemorrhoid ReliefWITCH HAZEL AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.e860d65b-126d-4d77-8003-9d1381849ab52026-08-20WarningsExact identifier
application number: M016
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
application number: M016
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
application number: M016
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
application number: M016
ClaravieLANOLINGentell LLC596c1b73-e34d-c97d-e063-6394a90ada1b2026-08-19WarningsExact identifier
application number: M016
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
application number: M016
ClaraVieLANOLINGentell LLC596fe32d-be34-0635-e063-6394a90a2fc02026-08-19WarningsExact identifier
application number: M016
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsExact identifier
application number: M016
Eczema Skin Relief CreamCOLLOIDAL OATMEALCVS Health98fac854-f7b0-4c6e-888d-1bdc6b9323b92026-08-17WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsExact identifier
application number: M016
Intimate CareGelHYALURONIC ACIDGuangzhou Yilong Cosmetics.,Ltd5918d204-52db-e6d0-e063-6394a90ab78c2026-08-14WarningsExact identifier
application number: M016
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP087d66ff-1a8c-dcb2-e063-6294a90a2f8c2026-08-11WarningsExact identifier
application number: M016
Nail Renewal LiquidGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.581f7192-fc17-a706-e063-6394a90a3ffa2026-08-11WarningsExact identifier
application number: M016
Intertrigo Relief CreamGLYCERINShantou South Moon Biotechnology Co., Ltd.587220c9-0ae9-3438-e063-6394a90a0a862026-08-07WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
967558Balmex 11.3 % Topical CreamPSNf7f7a89d-d4e0-9faa-e053-6294a90aaf7b3
630923zinc oxide 11.3 % Topical CreamPSNf7f7a89d-d4e0-9faa-e053-6294a90aaf7b3
967558zinc oxide 113 MG/ML Topical Cream [Balmex]SBDf7f7a89d-d4e0-9faa-e053-6294a90aaf7b3
630923zinc oxide 113 MG/ML Topical CreamSCDf7f7a89d-d4e0-9faa-e053-6294a90aaf7b3
967558Balmex 11.3 % Topical CreamSYf7f7a89d-d4e0-9faa-e053-6294a90aaf7b3
967558Balmex 113 MG/ML Topical CreamSYf7f7a89d-d4e0-9faa-e053-6294a90aaf7b3
967558Balmex Diaper Rash Cream StickSYf7f7a89d-d4e0-9faa-e053-6294a90aaf7b3
630923zinc oxide 11.3 % Topical CreamSYf7f7a89d-d4e0-9faa-e053-6294a90aaf7b3
630923ZNO 113 MG/ML Topical CreamSYf7f7a89d-d4e0-9faa-e053-6294a90aaf7b3
967558ZNO 113 MG/ML Topical Cream [Balmex]SYf7f7a89d-d4e0-9faa-e053-6294a90aaf7b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52412-285-02524120285021 TUBE in 1 CARTON (52412-285-02) / 56 g in 1 TUBE1 tube2021-04-19NoNoCurrent
52412-285-03524120285031 TUBE in 1 CARTON (52412-285-03) / 85 g in 1 TUBE1 tube2023-04-04NoNoCurrent
52412-285-04524120285041 TUBE in 1 CARTON (52412-285-04) / 113 g in 1 TUBE1 tube2021-04-19NoNoCurrent
52412-285-1252412028512340 g in 1 JAR (52412-285-12) 340 g2021-04-19NoNoCurrent
52412-285-1652412028516453 g in 1 JAR (52412-285-16) 453 g2021-04-19NoNoCurrent