FDA.reportPublic FDA data

Calamine

Product NDC
21130-941
11-digit product format
211300941
Labeler code
21130
Product ID
21130-941_56bae8dc-ee09-aa0f-e063-6294a90ae8d8
Type
HUMAN OTC DRUG
Nonproprietary name
FERRIC OXIDE RED
Dosage form
LOTION
Route
TOPICAL
Labeler
Better Living Brands, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-15
Substance
FERRIC OXIDE RED; ZINC OXIDE
Active strength
80; 80 mg/mL; mg/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 RED80 mg/mL
ZINC OXIDE80 mg/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
c7ef0ef3-6861-4b94-af4b-371fee8c1f3dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-941-30Calamine177 mL in 1 BOTTLE, PLASTICLOTION17714

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERRIC OXIDE REDACTIVE INGREDIENT1K09F3G675CALAMINE (FERRIC OXIDE RED) LOTION [BETTER LIVING BRANDS LLC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALAMINE (FERRIC OXIDE RED) LOTION [BETTER LIVING BRANDS LLC]1
FERRIC OXIDE REDACTIVE MOIETY1K09F3G675CALAMINE (FERRIC OXIDE RED) LOTION [BETTER LIVING BRANDS LLC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALAMINE (FERRIC OXIDE RED) LOTION [BETTER LIVING BRANDS LLC]1
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CCALAMINE (FERRIC OXIDE RED) LOTION [BETTER LIVING BRANDS LLC]1
CALCIUM HYDROXIDEINACTIVE INGREDIENTPF5DZW74VNCALAMINE (FERRIC OXIDE RED) LOTION [BETTER LIVING BRANDS LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALAMINE (FERRIC OXIDE RED) LOTION [BETTER LIVING BRANDS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCALAMINE (FERRIC OXIDE RED) LOTION [BETTER LIVING BRANDS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-941CALAMINE (FERRIC OXIDE RED) LOTION [BETTER LIVING BRANDS LLC]13Current NDC, Legacy NDC, 1 package rows20250416_c7ef0ef3-6861-4b94-af4b-371fee8c1f3d.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 15 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips Peppermint SwirlDIMETHICONEThe Mentholatum Company4dbea50e-d82d-c702-e063-6394a90ac6e42026-03-24WarningsExact identifier
application number: M016
Softlips VanillaDIMETHICONEThe Mentholatum Company56551008-a4e0-406f-8403-980d2e6b75a02026-03-24WarningsExact identifier
application number: M016
Selan Plus Zinc OxideSELAN PLUS ZINC OXIDETrividia Manufacturing Solutions, Inc07396c61-1dfd-4be7-bddf-0eb570a184632026-03-24WarningsExact identifier
application number: M016
D-CerinMOISTURIZERDynarex Corporation7ea47a7e-12af-9290-e053-2a91aa0a065f2026-03-24WarningsExact identifier
application number: M016
MG217 Eczema BodyCOLLOIDAL OATMEALWisconsin Pharmacal Company5f0cfd0c-ae87-f411-e053-2a91aa0ac2512026-03-20WarningsExact identifier
application number: M016
Advanced Formula Scar Defense CreamALLANTOINYantai Aien Biotechnology Co., Ltd.4d5c70f9-da41-b535-e063-6294a90a73f22026-03-19WarningsExact identifier
application number: M016
TriplePaste Adult Care Rash TreatmentZINC OXIDEAdvantice Health, LLC2cf0575c-8d3d-1f16-e063-6294a90a629d2026-03-19WarningsExact identifier
application number: M016
multipurposeZINC OXIDE SKIN PROTECTANTAdvantice Health, LLC291563cc-7491-ce41-e063-6394a90ac6c12026-03-19WarningsExact identifier
application number: M016
Triple Diaper RashZINC OXIDEAdvantice Health, LLCd457c58d-8239-41c4-999e-d0ba237e39452026-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry PomegranateCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyf4464fb2-ba25-16f2-e053-2a95a90a04062026-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla CookieCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyfea4e5c7-780c-c7f4-e053-6294a90abb392026-03-19WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4d46110b-5aa7-5261-e063-6394a90a423a2026-03-18WarningsExact identifier
application number: M016
Advanced Bed Sore Wound HealingALLANTOINYantai Aien Biotechnology Co., Ltd.4d589c18-e597-355a-e063-6394a90a42432026-03-18WarningsExact identifier
application number: M016
MediChoice BarrierDIMETHICONEO&M HALYARD, INC.115c2a2f-d68a-316a-e063-6394a90a27162026-03-17WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4d4427b0-25c3-ddf6-e063-6394a90a61532026-03-17WarningsExact identifier
application number: M016
Colloidal OatmealCOLLOIDAL OATMEALWalmart Inc.4a93f77d-41dc-3bab-e063-6394a90a804b2026-03-16Warnings, Adverse reactionsExact identifier
application number: M016
VaselineHEALING JELLYConopco Inc. d/b/a Unileverbd4418b7-c6aa-5e71-e053-2995a90a4cc42026-03-16WarningsExact identifier
application number: M016
Vaseline Intensive Care Deep MoisturePETROLEUMConopco Inc. d/b/a Unilever65cec560-25c7-4076-a33d-a3dd534ff85b2026-03-16WarningsExact identifier
application number: M016
Daily MoisturizingDAILY MOISTRUIZINGWalgreen Co.27452cc7-1ec6-4571-bcd0-0a7103735ee52026-03-13Warnings, Adverse reactionsExact identifier
application number: M016
Tender Moments Delicate Baby Diaper Rash BalmDIMETHICONE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.f09ba452-e1a6-4f45-901f-bb63d4f8e8842026-03-13WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSNc7ef0ef3-6861-4b94-af4b-371fee8c1f3d14
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCDc7ef0ef3-6861-4b94-af4b-371fee8c1f3d14
617954calamine 8 % / zinc oxide 8 % Topical LotionSYc7ef0ef3-6861-4b94-af4b-371fee8c1f3d14
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSYc7ef0ef3-6861-4b94-af4b-371fee8c1f3d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-941-3021130094130177 mL in 1 BOTTLE, PLASTIC (21130-941-30) 177 ml2015-06-150000-00-00NoNoCurrent