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 9 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPRADERMWHITE PETROLATUM, LANOLINOlen Skin Care Corporation4e7199bd-52c6-48e9-9c78-c84e45412faf2026-06-10WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsExact identifier
application number: M016
BABY BUM DIAPERZINC OXIDECreative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare53d8a654-aaec-6f91-e063-6394a90a73512026-06-09WarningsExact identifier
application number: M016
CELISTAR MICRONEEDLING INFUSIONHYALURONATE SODIUMGuangdong Outeli Biotechnology Co., Ltd.53de46a7-3947-70a7-e063-6294a90ab8292026-06-09WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP3c448cf7-8ca5-c7f7-e063-6294a90a75ff2026-06-08WarningsExact identifier
application number: M016
WOODSLEEP Wild Yam CreamGLYCERINShantou Woodsleep Biotechnology Co., Ltd.53b992fd-5759-57bb-e063-6394a90a16002026-06-08WarningsExact identifier
application number: M016
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
application number: M016
GNP Calamine Topical SuspensionCALAMINE 8% AND ZINC OXIDE 8%Amerisource Bergen777b0e66-1bce-4483-9dad-c46796fd6f232026-06-04WarningsExact identifier
application number: M016
GNP CaldyphenCALAMINE AND PRAMOXINE HYDROCHLORIDEAmerisource Bergen515c58d7-0dc4-45e7-9155-e5270a16290e2026-06-04WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company535a0e8e-6bb4-6652-e063-6394a90aa7ff2026-06-03WarningsExact identifier
application number: M016
Quad WashDIMETHICONEDynarex Corporation535dc862-6a18-26c9-e063-6294a90a3d4a2026-06-03WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.535e42a1-8b14-324d-e063-6394a90a3f652026-06-03WarningsExact identifier
application number: M016
Petroleum Jelly Skin ProtectantWHITE PETROLATUMAcme United Corporation535e94bb-21e8-90be-e063-6394a90a37bb2026-06-03WarningsExact identifier
application number: M016
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
application number: M016
PUTRIZEN 40 UREAGLYCERINShantou Ximonth Biotechnology Co., Ltd.533dadbc-6f20-d880-e063-6394a90a753f2026-06-01WarningsExact identifier
application number: M016
ADVANCED HEALING BALMPETROLATUMRejoice International Corp.53285d82-3755-ca78-e063-6394a90a50192026-05-31WarningsExact identifier
application number: M016
KIEHLS SINCE 1851 Ultra Facial Meltdown RecoveryCOLLOIDAL OATMEALLOreal USA Products Inc22e088b9-b3b1-4c34-be12-a5a31200ec252026-05-29WarningsExact identifier
application number: M016
Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.53008b89-89ab-7650-e063-6294a90ac16c2026-05-29WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED52efd466-49bd-bbdf-e063-6394a90aa1082026-05-28WarningsExact identifier
application number: M016
TheraCare Vitamin A and D plus EPETROLATUMVeridian Healthcare52e0e248-6c04-feb9-e063-6394a90add462026-05-28WarningsExact 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