Home NDC 41163-536 Calamine
Product NDC 41163-536
11-digit product format 411630536
Labeler code 41163
Product ID 41163-536_5aa99c82-3d5d-b0a0-e063-6394a90a1b11
Type HUMAN OTC DRUG
Nonproprietary name Calamine, Pramoxine HCl
Dosage form LOTION
Route TOPICAL
Labeler United Natural Foods, Inc. dba UNFI
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-05-21
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 41163-536-30 Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-536 CALAMINE (CALAMINE, PRAMOXINE HCL) LOTION [UNITED NATURAL FOODS, INC. DBA UNFI] 5 Current NDC, Legacy NDC, 1 package rows 20240925_0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea.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 41163-536-30 41163053630 177 mL in 1 BOTTLE, PLASTIC (41163-536-30) 177 ml 2009-05-21 0000-00-00 No No Current