FDA.reportPublic FDA data

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
IngredientStrength
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [iU]/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
55dc4025-f07f-41b2-8b18-6a11ee04b5ccAvailable 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
36800-381-01TopCareAntibiotic Plus Pain Relief1 in 1 CARTONCREAM14
36800-381-01TopCareAntibiotic Plus Pain Relief14.2 g in 1 TUBECREAM14.24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Neomycin SulfateACTIVE INGREDIENT057Y626693TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]1
Pramoxine HydrochlorideACTIVE INGREDIENT88AYB867L5TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]1
NeomycinACTIVE MOIETYI16QD7X297TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KTOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]1
PramoxineACTIVE MOIETY068X84E056TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TTOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPTOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UTOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]1
waterINACTIVE INGREDIENT059QF0KO0RTOPCARE 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
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-381TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20241114_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 126 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense anti itchHYDROCORTISONEL. Perrigo Companyb7a896cc-1d78-45c0-a73e-aa1e117f7d3b2024-09-29WarningsExact identifier
application number: M017
Topcare HydrocortisoneHYDROCORTISONETopco Associates LLCb7362f21-f1a3-4edc-b5b6-a16680e05df32024-09-29WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEH E B412ca2d1-064b-4438-aee1-fcb5cf27c7db2024-09-29WarningsExact identifier
application number: M017
Topcare AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDETopco Associates LLC8c349cac-20e1-4600-9b0a-fcfe929551c52024-09-26WarningsExact identifier
application number: M017
good sense anti itchHYDROCORTISONEA-S Medication Solutions072dd455-24a5-4a44-aaef-d3e137d005a62024-09-26WarningsExact identifier
application number: M017
SYREN Intimate ReliefLIDOCAINE HYDROCHLORIDEIcon Health Science57d5a080-3583-4510-e053-2a91aa0ad5892024-09-25WarningsExact identifier
application number: M017
AOSI HEALTHCAREHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.f4db90ad-dd62-44f1-9655-2614ed36581e2024-09-25WarningsExact identifier
application number: M017
AOSI HEALTHCARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a28b920c-0bb8-4b5a-addd-26ea164e036e2024-09-25WarningsExact identifier
application number: M017
anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger Company067e718a-ec0b-4895-8f9f-82d64ab4c7b42024-09-24WarningsExact identifier
application number: M017
topcare anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATETopco Associates LLCe0fb332a-2903-41ef-b35b-7cd3a74cff992024-09-24WarningsExact identifier
application number: M017
equaline anti itchHYDROCORTISONEUnited Natural Foods, Inc. dba UNFI83cd9f60-a4c4-4dea-97a7-cd96aade9e882024-09-24WarningsExact identifier
application number: M017
good sense itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEL. Perrigo Company162fe0a3-3995-4e6f-94ed-f839b2b0c80e2024-09-24WarningsExact identifier
application number: M017
Caring Mill Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEVeridian Healthcare22ca137a-576c-a13c-e063-6394a90ae7fc2024-09-23WarningsExact identifier
application number: M017
Signature Care Anti ItchHYDROCORTISONESafewayed0eb068-3ce6-423d-a7f8-c3456b7f60402024-09-23WarningsExact identifier
application number: M017
members mark hydrocortisoneHYDROCORTISONESam's West Inc218f0dcd-fa67-4935-8019-ecbbd53ed2f72024-09-23WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEMeijer, Inc.a07496e0-6fc2-4190-8a01-f513134ffb922024-09-23WarningsExact identifier
application number: M017
ZYLOTROL PAIN RELIEVINGLIDOCAINE HCL, MENTHOLWhitestone Products LLC2301fed7-0fa9-450d-8b1b-006f53235be02024-09-21WarningsExact identifier
application number: M017
Tibetree Cheezheng Joint Analgesic PatchCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd65a8a63f-1864-473e-be72-7840a6a5dee72024-09-20WarningsExact identifier
application number: M017
Cold Ice Analgesic GelMENTHOLDabur India Limited22915b2f-5f76-3e38-e063-6394a90a07b42024-09-20WarningsExact identifier
application number: M017
Exchange Select HydrocortisoneHYDROCORTISONEArmy & Air Force Exchange Service1b709db3-7dc1-4756-a8a0-dddda875dc572024-09-19WarningsExact 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 CreamPSN55dc4025-f07f-41b2-8b18-6a11ee04b5cc4
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD55dc4025-f07f-41b2-8b18-6a11ee04b5cc4
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY55dc4025-f07f-41b2-8b18-6a11ee04b5cc4
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY55dc4025-f07f-41b2-8b18-6a11ee04b5cc4
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY55dc4025-f07f-41b2-8b18-6a11ee04b5cc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-381-01368000381011 TUBE in 1 CARTON (36800-381-01) / 14.2 g in 1 TUBE1 tube2012-03-210000-00-00NoNoCurrent