Home NDC 68071-4322 Calamine
Product NDC 68071-4322
11-digit product format 680714322
Labeler code 68071
Product ID 68071-4322_1a3dc619-6b13-21b4-e063-6294a90acb1e
Type HUMAN OTC DRUG
Nonproprietary name FERRIC OXIDE RED
Dosage form LOTION
Route TOPICAL
Labeler NuCare Pharmaceuticals,Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-01-07
Substance FERRIC OXIDE RED; ZINC OXIDE
Active strength 8; 8 g/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXIDE RED 8 g/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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4322-6 Calamine 177 mL in 1 BOTTLE LOTION 177 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4322 CALAMINE (FERRIC OXIDE RED) LOTION [NUCARE PHARMACEUTICALS,INC.] 5 Current NDC, Legacy NDC, 1 package rows 20240706_66e98554-e158-a519-e053-2a91aa0a6783.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 30 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 68071-4322-6 68071432206 177 mL in 1 BOTTLE (68071-4322-6) 177 ml 2018-03-08 0000-00-00 No No Current