Home NDC 82645-418 Calamine
Product NDC 82645-418
11-digit product format 826450418
Labeler code 82645
Product ID 82645-418_52b97551-89e2-c3b8-e063-6394a90af476
Type HUMAN OTC DRUG
Nonproprietary name Calamine and Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Pharma Nobis, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-16
Substance FERRIC OXIDE RED; ZINC OXIDE
Active strength 80; 80 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 82645-418-96 Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82645-418 CALAMINE (CALAMINE AND ZINC OXIDE) LOTION [PHARMA NOBIS, LLC] 2 Current NDC, 1 package rows 20231229_fbcfa541-beda-06de-e053-6294a90a9298.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 57 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 Sample Exclude flag Status 82645-418-96 82645041896 177 mL in 1 BOTTLE, PLASTIC (82645-418-96) 177 ml 2023-05-16 No No Current