Home NDC 36800-381 TopCare
Product NDC 36800-381
11-digit product format 368000381
Labeler code 36800
Product ID 36800-381_39ac8059-4dd6-6d84-e063-6294a90a8496
Type HUMAN OTC DRUG
Nonproprietary name Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Topco Associates LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-03-21
Substance NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength 3.5; 10000; 10 mg/g; [iU]/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
Brand name suffix Antibiotic Plus Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEOMYCIN SULFATE 3.5 mg/g POLYMYXIN B SULFATE 10000 [iU]/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 36800-381-01 TopCareAntibiotic Plus Pain Relief 1 in 1 CARTON CREAM 1 4 36800-381-01 TopCareAntibiotic Plus Pain Relief 14.2 g in 1 TUBE CREAM 14.2 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Neomycin Sulfate ACTIVE INGREDIENT 057Y626693 TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 1 Polymyxin B Sulfate ACTIVE INGREDIENT 19371312D4 TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 1 Pramoxine Hydrochloride ACTIVE INGREDIENT 88AYB867L5 TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 1 Neomycin ACTIVE MOIETY I16QD7X297 TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 1 Polymyxin B ACTIVE MOIETY J2VZ07J96K TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 1 Pramoxine ACTIVE MOIETY 068X84E056 TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 1 mineral oil INACTIVE INGREDIENT T5L8T28FGP TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 1 petrolatum INACTIVE INGREDIENT 4T6H12BN9U TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 1 water INACTIVE INGREDIENT 059QF0KO0R TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-381 TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241114_55dc4025-f07f-41b2-8b18-6a11ee04b5cc.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 127 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Caring Mill Anti-Itch Cream DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Veridian Healthcare 22ca137a-576c-a13c-e063-6394a90ae7fc 2024-09-23 Warnings Exact identifier application number: M017 Signature Care Anti Itch HYDROCORTISONE Safeway ed0eb068-3ce6-423d-a7f8-c3456b7f6040 2024-09-23 Warnings Exact identifier application number: M017 members mark hydrocortisone HYDROCORTISONE Sam's West Inc 218f0dcd-fa67-4935-8019-ecbbd53ed2f7 2024-09-23 Warnings Exact identifier application number: M017 anti itch HYDROCORTISONE Meijer, Inc. a07496e0-6fc2-4190-8a01-f513134ffb92 2024-09-23 Warnings Exact identifier application number: M017 ZYLOTROL PAIN RELIEVING LIDOCAINE HCL, MENTHOL Whitestone Products LLC 2301fed7-0fa9-450d-8b1b-006f53235be0 2024-09-21 Warnings Exact identifier application number: M017 Tibetree Cheezheng Joint Analgesic Patch CAMPHOR Tibet Cheezheng Tibetan Medicine Co. Ltd 65a8a63f-1864-473e-be72-7840a6a5dee7 2024-09-20 Warnings Exact identifier application number: M017 Cold Ice Analgesic Gel MENTHOL Dabur India Limited 22915b2f-5f76-3e38-e063-6394a90a07b4 2024-09-20 Warnings Exact identifier application number: M017 Exchange Select Hydrocortisone HYDROCORTISONE Army & Air Force Exchange Service 1b709db3-7dc1-4756-a8a0-dddda875dc57 2024-09-19 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Stratus Pharmaceuticals Inc e1a8d4a7-01f7-4bab-8d09-875c461b3b61 2024-09-19 Warnings Exact identifier application number: M017 Camphor Spirit CAMPHOR 10% Strategic Sourcing Services, LLC 2216d799-7f6f-cab7-e063-6294a90a8d6c 2024-09-14 Warnings Exact identifier application number: M017 Meijer Analgesic Lidocaine Topical Analgesic LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc f5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa 2024-09-12 Warnings Exact identifier application number: M017 leader anti itch DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Cardinal Health 110, LLC. dba Leader e1aab35b-80d9-4515-afb7-8c662bc5d028 2024-09-11 Warnings Exact identifier application number: M017 LactiGo MENTHOL LactiGo, Inc. 849c3601-2bc8-0991-e053-2a91aa0a5e7f 2024-09-03 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief Gel Platinum - Arthritis MENTHOL 8% Telebrands Corp c22cf1a5-0d5d-5ea5-e053-2995a90a333b 2024-09-02 Warnings Exact identifier application number: M017 Itch and Rash Cream HYDROCORTISONE Wildman Business Group 1f95757d-a434-f02a-e063-6294a90a2d12 2024-09-01 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Wildman Business Group 1fd1a4b3-b6fd-0d4c-e063-6394a90a3680 2024-09-01 Warnings Exact identifier application number: M017 Thera Care Cold Hot Medicated Patch MENTHOL Veridian Healthcare b1ce129d-06a1-7755-e053-2995a90abd7d 2024-08-29 Warnings Exact identifier application number: M017 BIOSAVIA External Analgesic Pain Relief CAPSAICIN BIOSAVIA USA, LLC 814aa66b-7719-4a29-a84e-18290367e9c7 2024-08-28 Warnings Exact identifier application number: M017 Careland Plantar Fasciitis Hydrogel Pain Patches LIDOCAINE, MENTHOL Planet (Anhui) Pharmaceutical Co., Ltd. 0e2f29c2-2e95-4be0-b7e9-f1761a1321a5 2024-08-21 Warnings Exact identifier application number: M017 Careland Max Strength Lidocaine 4 Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 265b8dd7-64a4-4bc2-a91c-26c761c2090b 2024-08-21 Warnings Exact identifier application number: M017
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 36800-381-01 36800038101 1 TUBE in 1 CARTON (36800-381-01) / 14.2 g in 1 TUBE 1 tube 2012-03-21 0000-00-00 No No Current