Home NDC 11344-136 Calamine
Product NDC 11344-136
11-digit product format 113440136
Labeler code 11344
Product ID 11344-136_5c148e64-6bd1-2028-e063-6294a90a2872
Type HUMAN OTC DRUG
Nonproprietary name Calamine, Pramoxind HCl
Dosage form LOTION
Route TOPICAL
Labeler Nice-Pak Products, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-09-08
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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11344-136-30 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 11344-136 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [CONSUMER PRODUCT PARTNERS, LLC] 1 Current NDC, 1 package rows 20240731_9089e23e-ca4a-454f-8dcc-ff5a29a5a335.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 11344-136-30 11344013630 177 mL in 1 BOTTLE, PLASTIC (11344-136-30) 177 ml 2016-09-08 No No Current