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 114 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TheraCare Maximum Strength Pain Relief Patch LIDOCAINE Veridian Healthcare dfaf8a77-2276-4791-e053-2a95a90a3288 2024-12-10 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE Alexso, Inc eef555d3-f23d-4847-93f3-fa7a06072a0f 2024-12-09 Warnings Exact identifier application number: M017 Lidocaine 4 Percent LIDOCAINE SA3, LLC 651710db-3c50-4bcf-b7cc-9ed24f663427 2024-12-09 Warnings Exact identifier application number: M017 HealthWise Pain Relief Lidocaine Patch LIDOCAINE 4% Veridian Healthcare 28db1c03-d01f-83ea-e063-6294a90aee26 2024-12-09 Warnings Exact identifier application number: M017 Joint and Muscle Pain Relief MENTHOL Allure Labs e82f99fd-c2ef-686f-e053-2a95a90a1dc9 2024-12-09 Warnings Exact identifier application number: M017 Tough Love Pain Relieving LIDOCAINE HCL Allure Labs ee8c1a2b-36ef-6fd7-e053-2a95a90a9c01 2024-12-09 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN SA3, LLC 5617e91d-e650-4a0d-8565-b8288ea41c77 2024-12-09 Warnings Exact identifier application number: M017 Medicaine Sting and Bite BENZOCAINE James Alexander Corporation 753e6cbe-31e0-4017-93d0-8b4bf5972f37 2024-12-09 Warnings Exact identifier application number: M017 AUVON Pain Relief Roll-on MENTHOL SHENZHEN YUWEN E-COMMERCE CO., LTD. df239c4d-af6a-41ca-baed-d0788782ce9f 2024-12-08 Warnings Exact identifier application number: M017 AUVON Pain Relief Roll-on LIDOCAINE SHENZHEN YUWEN E-COMMERCE CO., LTD. 8b30f623-6077-4f2e-8fa4-ce4a298953b5 2024-12-08 Warnings Exact identifier application number: M017 QC Medicated anti itch PRAMOXINE HYDROCHLORIDE, MENTHOL Chain Drug Marketing Association b5e41e3a-81df-3a63-e053-2a95a90a5839 2024-12-08 Warnings Exact identifier application number: M017 QC Lidocaine Maximum Strength LIDOCAINE HCL Chain Drug Marketing Association b5e1b1ab-8a95-2d2d-e053-2995a90aea53 2024-12-08 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN Alexso, Inc 433da27d-04fb-481a-bbb0-874bb72c806a 2024-12-06 Warnings Exact identifier application number: M017 POMG PAIN RELIEF BODY LIDOCAINE POMG LLC 28d7ac46-b27f-43bb-e063-6294a90a93ed 2024-12-06 Warnings Exact identifier application number: M017 Capsaicin 0.1 Percent CAPSAICIN Alexso, Inc 0090ca38-6433-45c4-9453-edf2788c14c6 2024-12-06 Warnings Exact identifier application number: M017 Signature Care Menthol MENTHOL 4% Safeway 27d3cb47-a6c7-5b7a-e063-6394a90a056f 2024-12-05 Warnings Exact identifier application number: M017 ITCH X BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE BF ASCHER AND CO INC 03c16d33-8f59-0184-e054-00144ff8d46c 2024-12-05 Warnings Exact identifier application number: M017 PO First Aid Series BURN LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. f1c349a8-216d-4233-922e-c95329a33d1e 2024-12-05 Warnings Exact identifier application number: M017 Post Treatment Balm HYDROCORTISONE Allure Labs Inc. faa803e6-453c-4d86-85dd-5a5dcdd72d02 2024-12-05 Warnings Exact identifier application number: M017 CBD Pain Relief Cream TROLAMINE SALICYLATE Allure Labs b6b3102a-4154-2da2-e053-2995a90ae99f 2024-12-05 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