Home NDC 55319-063 Calamine
Product NDC 55319-063
11-digit product format 553190063
Labeler code 55319
Product ID 55319-063_4b931e99-fa6e-6400-e063-6394a90a9874
Type HUMAN OTC DRUG
Nonproprietary name FERRIC OXIDE RED
Dosage form LOTION
Route TOPICAL
Labeler Family Dollar Stores, Inc
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 1989-07-15
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 Ingredient Strength FERRIC OXIDE RED 80 mg/mL ZINC OXIDE 80 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 55319-063-30 Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-063 CALAMINE (FERRIC OXIDE RED) LOTION [FAMILY DOLLAR SERVICES, INC.] 18 Current NDC, Legacy NDC, 1 package rows 20240831_1a03331e-3676-451c-be22-9a547e8ae6e2.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 28 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 55319-063-30 55319006330 177 mL in 1 BOTTLE, PLASTIC (55319-063-30) 177 ml 1989-07-15 0000-00-00 No No Current