Home NDC 83324-242 Calamine Plus
Product NDC 83324-242
11-digit product format 833240242
Labeler code 83324
Product ID 83324-242_42f3eea8-94ff-28c8-e063-6394a90ad853
Type HUMAN OTC DRUG
Nonproprietary name Calamine Plus Pramoxine HCL
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Chain Drug Marketing Association Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-07
Substance FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength 5; 10; 79.5 mg/g; mg/g; mg/g
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 Plus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXIDE RED 5 mg/g PRAMOXINE HYDROCHLORIDE 10 mg/g ZINC OXIDE 79.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1K09F3G675 Internal UNII lookup 88AYB867L5 Internal UNII lookup SOI2LOH54Z Internal UNII 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 83324-242-41 Calamine Plus 116 g in 1 CANISTER AEROSOL, SPRAY 116 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83324-242 CALAMINE PLUS (CALAMINE PLUS PRAMOXINE HCL) AEROSOL, SPRAY [CHAIN DRUG MARKETING ASSOCIATION INC] 2 Current NDC, 1 package rows 20241213_1a3f8819-58cf-8923-e063-6394a90a37af.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 48 of 151 · 3,010 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83324-242-41 83324024241 116 g in 1 CANISTER (83324-242-41) 116 g 2024-06-07 No No Current