Home NDC 81522-959 Calamine Plus Pramoxine HCl
Product NDC 81522-959
11-digit product format 815220959
Labeler code 81522
Product ID 81522-959_3cd1933c-6340-50d6-e063-6294a90aca32
Type HUMAN OTC DRUG
Nonproprietary name Calamine Plus Spray
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler FSA Store Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-12
Substance FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength 5; 75; 10 mg/g; mg/g; mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Pramoxine HCl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXIDE RED 5 mg/g ZINC OXIDE 75 mg/g PRAMOXINE HYDROCHLORIDE 10 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 SOI2LOH54Z 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 1544717 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 81522-959-01 Calamine Plus Pramoxine HCl 116 g in 1 CAN AEROSOL, SPRAY 116 1
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 112 of 153 · 3,057 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 81522-959-01 81522095901 116 g in 1 CAN (81522-959-01) 116 g 2025-08-12 No No Current