Home NDC 53943-400 DDM Calaclear
Product NDC 53943-400
11-digit product format 539430400
Labeler code 53943
Product ID 53943-400_0ce5be01-e0bc-7245-e063-6294a90acccf
Type HUMAN OTC DRUG
Nonproprietary name Zinc Acetate and Pramoxine Hydrochloride
Dosage form LOTION
Route TOPICAL
Labeler Discount Drug Mart
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 1998-03-25
Substance ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength 80; 10 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 DDM Calaclear
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 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 SOI2LOH54Z Internal UNII lookup 88AYB867L5 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 53943-400-96 DDM Calaclear 177 mL in 1 BOTTLE, PLASTIC LOTION 177 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53943-400 DDM CALACLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [DISCOUNT DRUG MART] 4 Current NDC, Legacy NDC, 1 package rows 20231220_5d536077-b5c6-29b8-e053-2a91aa0a9ae1.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 52 of 68 · 1,346 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53943-400-96 53943040096 177 mL in 1 BOTTLE, PLASTIC (53943-400-96) 177 ml 2017-10-26 0000-00-00 No No Current