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 136 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rugby Capsaicin External Analgesic CAPSAICIN Proficient Rx LP 7c733a30-5002-49e7-a6bd-7737a1d2461e 2024-02-01 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Proficient Rx LP ccb62898-b614-45b9-95ea-23e5e31893a8 2024-02-01 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE Proficient Rx LP 0b26d92f-9d0e-46d4-a8bc-75d6da5f6199 2024-02-01 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Proficient Rx LP c57d5f8e-5934-4cbb-999a-cdd55e5b105f 2024-02-01 Warnings Exact identifier application number: M017 hydrocortisone HYDROCORTISONE Proficient Rx LP 47e9fe84-bd0c-40ea-85de-e950bcacc557 2024-02-01 Warnings Exact identifier application number: M017 Joint and Muscle Pain MENTHOL Shaklee Corporation 3943824f-1f4f-4d6f-bd73-0b1be02162a5 2024-01-30 Warnings Exact identifier application number: M017 Mirakel Pain Relief Roll-On LIDOCAINE HCL Sanvio, Inc. 102f3618-13ad-37e3-e063-6294a90a8086 2024-01-30 Warnings Exact identifier application number: M017 Blistex Lip Medex PETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOL Blistex Inc. 8ad39005-9419-4f1a-a1ae-2f76d212455e 2024-01-26 Warnings Exact identifier application number: M017 Point Relief Cold Spot Pain Relieving MENTHOL Fabrication Enterprises ad5d6f04-15e6-4548-95c2-32271c186bc1 2024-01-25 Warnings Exact identifier application number: M017 MIND BODY MATRIX PAIN RELIEF MENTHOL Functional Energetic, Inc. 3667dd0d-942e-4101-ba98-cb013ae77cf5 2024-01-25 Warnings Exact identifier application number: M017 SUPER WHITE STUFF Pain Relief MENTHOL BLUE SPRING WELLNESS e6d27df5-118c-4c6d-86e8-7b4401a39c76 2024-01-23 Warnings Exact identifier application number: M017 Burn First Aid BURN FIRST AID Dynarex Corporation 826e08be-dffa-5a27-e053-2a91aa0a8701 2024-01-22 Warnings Exact identifier application number: M017 Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On MENTHOL TARGET CORPORATION 0f95fc55-8665-9e89-e063-6394a90a7891 2024-01-22 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain Relief Plus Menthol LIDOCAINE, MENTHOL, UNSPECIFIED FORM Natural Essentials, Inc. 77978069-a1b4-473e-83c9-8320e00eea89 2024-01-19 Warnings Exact identifier application number: M017 ZIMS MAX FREEZE LEG CRAMPS CAMPHOR, MENTHOL KOBAYASHI Healthcare International, Inc. ba26635d-95d3-4d88-93cc-1fd4fd29fd79 2024-01-18 Warnings Exact identifier application number: M017 Burn LIDOCAINE HART Health e95ebdac-9789-41c2-97da-2307e4538794 2024-01-18 Warnings Exact identifier application number: M017 Medi-First Hydrocortisone 1% HYDROCORTISONE ACETATE Unifirst First Aid Corporation bd216f5d-f304-7d8d-e053-2a95a90aa9ce 2024-01-17 Warnings Exact identifier application number: M017 Green Guard Hydrocortisone 1% HYDROCORTISONE Unifirst First Aid Corporation bd348e2a-57b1-3f17-e053-2a95a90a8bdc 2024-01-17 Warnings Exact identifier application number: M017 Pain Relief LIDOCAINE, MENTHOL HUMN Pharmaceuticals Inc 6c96f94a-e724-eab3-e053-2991aa0aab88 2024-01-17 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain Relief LIDOCAINE Natural Essentials, Inc. 52e82e70-53b7-4ecb-be39-fe10c94cc444 2024-01-17 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