Home NDC 36800-976 Topcare Antibiotic
Product NDC 36800-976
11-digit product format 368000976
Labeler code 36800
Product ID 36800-976_cc235da2-c30c-4192-a5e7-5956c5981d72
Type HUMAN OTC DRUG
Nonproprietary name neomycin, polymyxin B, pramoxine hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Topco Associates LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-04-03
Substance NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 Antibiotic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEOMYCIN SULFATE 3.5 mg/g POLYMYXIN B SULFATE 10000 [USP'U]/g PRAMOXINE HYDROCHLORIDE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 057Y626693 Internal UNII lookup 19371312D4 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 1359360 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 36800-976-58 Topcare Antibiotic 1 in 1 CARTON CREAM 1 4 36800-976-58 Topcare Antibiotic 14 g in 1 TUBE CREAM 14 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-976 TOPCARE ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240927_8c349cac-20e1-4600-9b0a-fcfe929551c5.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 77 of 153 · 3,057 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 36800-976-58 36800097658 1 TUBE in 1 CARTON (36800-976-58) / 14 g in 1 TUBE 1 tube 2020-04-03 0000-00-00 No No Current