Baby Mantra Diaper Cream

Product NDC
76348-825
11-digit product format
763480825
Labeler code
76348
Product ID
76348-825_32c47a66-a98d-817a-e063-6294a90ac7a3
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide 10%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Renu Laboratories, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-03
Substance
ZINC OXIDE
Active strength
10 g/100mL
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
Baby Mantra Diaper Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE10 g/100mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199099Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0427bbc9-f4c0-0eb6-e063-6294a90a7199Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-825-34Baby Mantra Diaper Cream100 mL in 1 TUBEOINTMENT1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-825BABY MANTRA DIAPER CREAM (ZINC OXIDE 10%) OINTMENT [RENU LABORATORIES, LLC]2Current NDC, 1 package rows20250416_0427bbc9-f4c0-0eb6-e063-6294a90a7199.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 62 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil HealingPETROLATUMGalderma Laboratories, L.P.e996db17-bd4d-4b06-bb9a-983dbdec80222024-03-13WarningsExact identifier
application number: M016
Diaper Rash Cream 2ozZINC OXIDERejoice International Corp.130a06a7-3360-afed-e063-6294a90ac19f2024-03-06WarningsExact identifier
application number: M016
mama bear DIAPER RASH Skin ProtectantLANOLIN AND PETROLATUMAMAZON.COM SERVICES LLCcda9ca47-b668-4a65-908d-80b9a6515bd72024-03-06WarningsExact identifier
application number: M016
Dermachange ScarALLANTOINPrivate Label Beauty and Wellness12eed473-10d6-49c8-e063-6394a90afb632024-03-05WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum Jelly Cocoa Butter EnrichedPETROLEUMRejoice International580d76ee-ea89-426e-bd25-7a58481e97952024-02-28WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum Jelly Vitamin E enrichedPETROLATUMRejoice International2c382a50-93d2-4d28-b7a4-1702b20b71392024-02-28WarningsExact identifier
application number: M016
XtraCare Foaming Facial CleanserTRICLOSANRejoice International313fcd4a-8641-417e-bf0b-02359ad815fe2024-02-28WarningsExact identifier
application number: M016
XtraCare Skin Relief Oatmeal Daily MoisturizingDIMETHICONERejoice International5ae6d5d4-caff-4360-a0e7-7c8d7a9b59072024-02-28WarningsExact identifier
application number: M016
XtraCare with cooling action Oatmeal Skin Relief CalminDIMETHICONERejoice International29abd476-c32d-49f0-b283-30f4ba570ab42024-02-28WarningsExact identifier
application number: M016
MAX BARRIER Skin ProtectantZINC OXIDEGL HEALTH, INC.5eec834d-d8f3-49e3-b230-f8cf88b795e62024-02-26WarningsExact identifier
application number: M016
Rugby Petrolatum Hydrating Skin ProtectantPETROLATUMRugby Laboratoriesad63e345-1fe8-4f9a-a32e-8dfcde31bedc2024-02-12WarningsExact identifier
application number: M016
A and DPETROLATUMSafetec of America, Inc.b9afda3a-9e1d-46c1-b7aa-c3143caf709e2024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Mint BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc86fc9f3c-e35f-4988-bf19-64d9c6c85ee92024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Berry BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc827365b3-b3a5-4472-9add-f822362c47312024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Lip BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc8b4160ed-8889-4e3a-947f-a56c3324dbbe2024-02-09WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP101b9933-c2b8-0fdd-e063-6294a90a306a2024-01-29WarningsExact identifier
application number: M016
XtraCare Skin Relief Oatmeal Daily MoisturizingDIMETHICONERejoice International8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc2024-01-29WarningsExact identifier
application number: M016
Cetaphil Baby HealingPETROLATUMGalderma Laboratories, L.P.5140754e-5db0-470f-adfd-de02b184880b2024-01-29WarningsExact identifier
application number: M016
CHAPSTICK CLASSIC MEDICATEDCAMPHOR, MENTHOL, PETROLATUMHaleon US Holdings LLCb4259621-ff41-46cc-a658-b57bff3c15252024-01-23WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USAfcef17f1-84e7-a288-e053-6294a90a064b2024-01-19WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199099zinc oxide 10 % Topical OintmentPSN0427bbc9-f4c0-0eb6-e063-6294a90a71992
199099zinc oxide 0.1 MG/MG Topical OintmentSCD0427bbc9-f4c0-0eb6-e063-6294a90a71992
199099zinc oxide 10 % Topical OintmentSY0427bbc9-f4c0-0eb6-e063-6294a90a71992
199099ZNO 0.1 MG/MG Topical OintmentSY0427bbc9-f4c0-0eb6-e063-6294a90a71992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76348-825-3476348082534100 mL in 1 TUBE (76348-825-34) 100 ml2024-01-03NoNoCurrent