FDA.reportPublic FDA data

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
IngredientStrength
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [USP'U]/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1359360Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c349cac-20e1-4600-9b0a-fcfe929551c5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-976-58Topcare Antibiotic1 in 1 CARTONCREAM14
36800-976-58Topcare Antibiotic14 g in 1 TUBECREAM144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-976TOPCARE ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 2 package rows20240927_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 89 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine PatchLIDOCAINEShenzhen Finona Information Technology Co., Ltd3875bde5-2e1a-5fdf-e063-6294a90a3c0d2025-06-26WarningsExact identifier
application number: M017
SupreH Bee Venom Arthritis Pain Relieving CreamSUPREH BEE VENOM ARTHRITIS PAIN RELIEVING CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3876cc44-7f3a-b084-e063-6294a90a61422025-06-26WarningsExact identifier
application number: M017
MediBalmHYDROCORTISONEBalmRx, LLC324dd151-84c5-3e2f-e063-6394a90a569d2025-06-26WarningsExact identifier
application number: M017
PHIZICO Pain ReliefMENTHOLER3 BRANDS INC.72715dc5-d1e7-4b4b-8e28-4e367abba3222025-06-25WarningsExact identifier
application number: M017
Diva Cramp Care CreamMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp37368566-b14e-4d5c-bdde-6eea9073974f2025-06-25WarningsExact identifier
application number: M017
H2Ocean NOTHING TATTOO GLIDE AFTERCARE MAX STRENGTHLIDOCAINE HCLH2Ocean, LLC386bf11b-1d71-44bf-e063-6394a90a28172025-06-25WarningsExact identifier
application number: M017
Burn Relief Extra Strength Kool-DownLIDOCAINE - 3.9%Kool-Down Inc827fec2f-db3c-adbb-e053-2a91aa0a7c172025-06-25WarningsExact identifier
application number: M017
Hilook Blue Gel AnestheticLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd1b9db681-a297-5aa9-e063-6394a90a80ea2025-06-25WarningsExact identifier
application number: M017
Hilook Numbing CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd1b9f1a4c-ca0b-d820-e063-6394a90a32392025-06-25WarningsExact identifier
application number: M017
Lidocaine Knee Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd384c1ff8-80bd-86cb-e063-6394a90a2d652025-06-24WarningsExact identifier
application number: M017
Aroamas Cot Nicotine Transdermal Patches KitNICOTINE TRANSDERMAL PATCHESPCHEERY LLC38576022-9413-c9af-e063-6294a90afd462025-06-24WarningsExact identifier
application number: M017
NERVE REVERSE PAIN RELIEFMENTHOLPogue Medical Servicesda97bcc6-5aa8-48e2-a2c2-c937745bf6d32025-06-23WarningsExact identifier
application number: M017
Medterra Pain Relief Menthol Roll-OnMENTHOLRespect Manufacturing Corporation05a6067a-287a-52d4-e063-6394a90a2c4e2025-06-23WarningsExact identifier
application number: M017
Medterra Pain Relief 500mg Hemp Menthol CreamMENTHOLRespect Manufacturing Corporation06c4640a-ee42-5d1a-e063-6394a90ad2542025-06-23WarningsExact identifier
application number: M017
Medterra Pain Relief 1000mg Hemp Menthol CreamMENTHOLRespect Manufacturing Corporation06e944e8-71f6-9fe9-e063-6294a90a8c372025-06-23WarningsExact identifier
application number: M017
Procure gelMENTHOLTWIN MED, LLCe69c0b68-d408-9fd2-e053-2a95a90ac9342025-06-20WarningsExact identifier
application number: M017
A Health Itch Relief GelITCH RELIEF GELBionpharma, Inc.38040732-48c9-3533-e063-6394a90af10a2025-06-20WarningsExact identifier
application number: M017
SCHOELIF Numbing CreamNUMBING CREAMGuangzhou Qiexiran Cosmetics Co., Ltd.37eaabb7-884e-0bd5-e063-6294a90ae0632025-06-19WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology37ee539c-df7e-511d-e063-6394a90a44692025-06-19WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology37eef80a-556f-b090-e063-6294a90a151b2025-06-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSN8c349cac-20e1-4600-9b0a-fcfe929551c54
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD8c349cac-20e1-4600-9b0a-fcfe929551c54
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY8c349cac-20e1-4600-9b0a-fcfe929551c54
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY8c349cac-20e1-4600-9b0a-fcfe929551c54
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY8c349cac-20e1-4600-9b0a-fcfe929551c54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-976-58368000976581 TUBE in 1 CARTON (36800-976-58) / 14 g in 1 TUBE1 tube2020-04-030000-00-00NoNoCurrent