Home NDC 83324-053 Calamine
Product NDC 83324-053
11-digit product format 833240053
Labeler code 83324
Product ID 83324-053_4bcf72e3-68ba-8e7d-e063-6294a90a7536
Type HUMAN OTC DRUG
Nonproprietary name Calamine, Pramoxine HCl
Dosage form LOTION
Route TOPICAL
Labeler Chain Drug Marketing Association
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-26
Substance FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
Active strength 80; 10 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 PRAMOXINE HYDROCHLORIDE 10 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 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234532 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83324-053-06 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 83324-053 CALAMINE (CALAMINE, PRAMOXINE HCL) LOTION [CDMA] 2 Current NDC, 1 package rows 20250228_6c848b98-f01c-40f2-a9aa-2af76cb370c8.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 55 of 68 · 1,350 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 83324-053-06 83324005306 177 mL in 1 BOTTLE, PLASTIC (83324-053-06) 177 ml 2025-02-26 No No Current