Home NDC 36800-268 TopCare Calagesic
Product NDC 36800-268
11-digit product format 368000268
Labeler code 36800
Product ID 36800-268_0ccb3962-d499-0a6c-e063-6294a90a0d41
Type HUMAN OTC DRUG
Nonproprietary name calamine and pramoxine hydrochloride lotion
Dosage form LOTION
Route TOPICAL
Labeler TOPCO ASSOCIATES LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-16
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 TopCare Calagesic
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234532 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 36800-268-96 TopCare Calagesic 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 36800-268 TOPCARE CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION) LOTION [TOPCO ASSOCIATES LLC] 5 Current NDC, Legacy NDC, 1 package rows 20231219_8dced3ea-147b-3d46-e053-2a95a90aa1c0.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 30 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 36800-268-96 36800026896 177 mL in 1 CONTAINER (36800-268-96) 177 ml 2019-07-16 0000-00-00 No No Current