FDA.reportPublic FDA data

Calamine

Product NDC
30142-063
11-digit product format
301420063
Labeler code
30142
Product ID
30142-063_586242cf-6171-2cb6-e063-6294a90a77f9
Type
HUMAN OTC DRUG
Nonproprietary name
FERRIC OXIDE RED
Dosage form
LOTION
Route
TOPICAL
Labeler
The Kroger Co.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-05-04
Substance
FERRIC OXIDE RED; ZINC OXIDE
Active strength
8; 8 g/mL; g/mL
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
Calamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC OXIDE RED8 g/mL
ZINC OXIDE8 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1K09F3G675Internal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
617954Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-063-30Calamine177 mL in 1 BOTTLE, PLASTICLOTION17714

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-063CALAMINE (FERRIC OXIDE RED) LOTION [KROGER CO]13Current NDC, Legacy NDC, 1 package rows20250411_9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308.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
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN9ddcd6ba-1aed-48f8-a91a-54bd6f0d930814
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD9ddcd6ba-1aed-48f8-a91a-54bd6f0d930814
617954calamine 8 % / zinc oxide 8 % Topical LotionSY9ddcd6ba-1aed-48f8-a91a-54bd6f0d930814
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY9ddcd6ba-1aed-48f8-a91a-54bd6f0d930814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-063-3030142006330177 mL in 1 BOTTLE, PLASTIC (30142-063-30) 177 ml2009-05-040000-00-00NoNoCurrent