Home NDC 11344-063 Calamine
Product NDC 11344-063
11-digit product format 113440063
Labeler code 11344
Product ID 11344-063_5b85784d-fcef-31cf-e063-6294a90a42e7
Type HUMAN OTC DRUG
Nonproprietary name Calamine, Zinc oxide
Dosage form LOTION
Route TOPICAL
Labeler Nice-Pak Products, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 1989-07-15
Substance FERRIC OXIDE RED; ZINC OXIDE
Active strength 80; 80 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 ZINC OXIDE 80 mg/mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11344-063-30 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 11344-063 CALAMINE (CALAMINE, ZINC OXIDE) LOTION [CONSUMER PRODUCT PARTNERS, LLC] 2 Current NDC, 1 package rows 20250309_c370ee1f-1887-44e8-8d47-8ffa3c270ff5.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 66 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 11344-063-30 11344006330 177 mL in 1 BOTTLE, PLASTIC (11344-063-30) 177 ml 1998-07-15 No No Current