FDA.reportPublic FDA data

Diaper Rash Cream 2.5oz

Product NDC
58503-170
Requested package NDC
58503-170-01
11-digit product format
585030170
Labeler code
58503
Product ID
58503-170_0baaab8c-1135-394f-e063-6394a90afa07
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetics Technology Corp.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-04
Substance
ZINC OXIDE
Active strength
.4 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Diaper Rash Cream 2.5oz
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE.4 g/g

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
1305337Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0baa8a14-8655-d77c-e063-6294a90ab8aaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-170-01Diaper Rash Cream 2.5oz1 in 1 BOXCREAM11
58503-170-01Diaper Rash Cream 2.5oz71 g in 1 TUBECREAM711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-170DIAPER RASH CREAM 2.5OZ (ZINC OXIDE) CREAM [CHINA NINGBO SHANGGE COSMETICS TECHNOLOGY CORP.]1Current NDC, 2 package rows20231205_0baa8a14-8655-d77c-e063-6294a90ab8aa.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 68 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Barrier BalmBARRIER BALMAutumn Harp, Inc.01df9746-991b-4363-e063-6294a90aaac62023-08-01WarningsExact identifier
application number: M016
Barrier CreamZINC OXIDEAvasol LLCbc6a2736-faa6-46d3-af9b-a70f0762e9ce2023-05-15WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy CaneCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybec2f702-5ff5-ea66-e053-2a95a90ad1ec2023-01-01WarningsExact identifier
application number: M016
Badger After-BUG BalmCOLLOIDAL OATMEALW.S. Badger Company, Inc.a623da47-cef2-146f-e053-2a95a90afe3a2021-11-17WarningsExact identifier
application number: M016
Derma-e Eczema ReliefOATMEALTopiderm, Ince1797f81-af4b-49e1-9906-dbfd904a282b2020-08-19WarningsExact identifier
application number: M016
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305337zinc oxide 40 % Topical CreamPSN0baa8a14-8655-d77c-e063-6294a90ab8aa1
1305337zinc oxide 400 MG/ML Topical CreamSCD0baa8a14-8655-d77c-e063-6294a90ab8aa1
1305337zinc oxide 40 % Topical CreamSY0baa8a14-8655-d77c-e063-6294a90ab8aa1
1305337ZNO 400 MG/ML Topical CreamSY0baa8a14-8655-d77c-e063-6294a90ab8aa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58503-170-01585030170011 TUBE in 1 BOX (58503-170-01) / 71 g in 1 TUBE1 tube2023-12-04NoNoCurrent