Home NDC 49035-402 Calaclear
Product NDC 49035-402
11-digit product format 490350402
Labeler code 49035
Product ID 49035-402_52b86437-892d-9ba2-e063-6294a90a7adb
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine Hydrochloride and Zinc Acetate
Dosage form LOTION
Route TOPICAL
Labeler Wal-Mart Stores, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-01-03
Substance PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength 10; 1 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 Calaclear
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 10 mg/mL ZINC ACETATE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88AYB867L5 Internal UNII lookup FM5526K07A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234546 Internal RxNorm lookup 1248193 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 49035-402-96 Calaclear 177 mL in 1 BOTTLE, PLASTIC LOTION 177 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-402 CALACLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [WAL-MART STORES, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20231220_61e76e2a-fc46-7a64-e053-2991aa0a56a8.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 28 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 49035-402-96 49035040296 177 mL in 1 BOTTLE, PLASTIC (49035-402-96) 177 ml 2018-01-03 0000-00-00 No No Current