Home NDC 75981-063 Calamine
Product NDC 75981-063
11-digit product format 759810063
Labeler code 75981
Product ID 75981-063_4b30bf8c-4f51-f880-e063-6294a90a8f77
Type HUMAN OTC DRUG
Nonproprietary name FERRIC OXIDE RED
Dosage form LOTION
Route TOPICAL
Labeler Perrigo Direct, Inc�
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 1992-09-15
Substance FERRIC OXIDE RED; ZINC OXIDE
Active strength 8; 8 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 Ingredient Strength FERRIC OXIDE RED 8 mg/mL ZINC OXIDE 8 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1K09F3G675 Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 617954 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75981-063-30 Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FERRIC OXIDE RED ACTIVE INGREDIENT 1K09F3G675 CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 FERRIC OXIDE RED ACTIVE MOIETY 1K09F3G675 CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 BENTONITE INACTIVE INGREDIENT A3N5ZCN45C CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 CALCIUM HYDROXIDE INACTIVE INGREDIENT PF5DZW74VN CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75981-063 CALAMINE (FERRIC OXIDE RED) LOTION [PERRIGO DIRECT, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20250410_256bd1d4-fd50-408f-9aee-84f218bb4971.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 45 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 75981-063-30 75981006330 177 mL in 1 BOTTLE, PLASTIC (75981-063-30) 177 ml 1992-09-15 0000-00-00 No No Current