Home NDC 36800-267 TopCare Calaclear
Product NDC 36800-267
11-digit product format 368000267
Labeler code 36800
Product ID 36800-267_0ccb3e8a-3d01-1364-e063-6294a90a70e8
Type HUMAN OTC DRUG
Nonproprietary name pramoxine hydrochloride and zinc acetate lotion
Dosage form LOTION
Route TOPICAL
Labeler TOPCO ASSOCIATES LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-16
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 TopCare 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234546 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 36800-267-96 TopCare Calaclear 177 mL in 1 CONTAINER LOTION 177 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-267 TOPCARE CALACLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION) LOTION [TOPCO ASSOCIATES LLC] 5 Current NDC, Legacy NDC, 1 package rows 20231219_8dce8817-b905-4064-e053-2995a90a071e.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 38 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 36800-267-96 36800026796 177 mL in 1 CONTAINER (36800-267-96) 177 ml 2019-07-16 0000-00-00 No No Current