FDA.reportPublic FDA data

topcare triple antibiotic

Product NDC
36800-416
11-digit product format
368000416
Labeler code
36800
Product ID
36800-416_ad03114a-7d22-43d3-9e2f-dc62936cd5d1
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin, polymyxin B
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-26
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], 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 triple antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204602Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
675665ee-bd0d-4168-81b8-341b1258c102Available 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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-416-26topcare triple antibiotic56 g in 1 TUBEOINTMENT564
36800-416-26topcare triple antibiotic2 in 1 CARTONOINTMENT24
36800-416-58topcare triple antibiotic14.2 g in 1 TUBEOINTMENT14.24
36800-416-58topcare triple antibiotic1 in 1 CARTONOINTMENT14
36800-416-64topcare triple antibiotic1 in 1 CARTONOINTMENT14
36800-416-64topcare triple antibiotic28 g in 1 TUBEOINTMENT284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-416TOPCARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 6 package rows20241013_675665ee-bd0d-4168-81b8-341b1258c102.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 22 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
application number: M004
GENUINE FIRST AID AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.23abfe12-5b50-4b49-878e-4fcdb6c341fd2023-10-19WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
application number: M004
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN675665ee-bd0d-4168-81b8-341b1258c1024
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD675665ee-bd0d-4168-81b8-341b1258c1024
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY675665ee-bd0d-4168-81b8-341b1258c1024

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-416-16368000416162 TUBE in 1 CARTON (36800-416-16) > 56 g in 1 TUBE2 tube2020-02-260000-00-00NoNoCurrent
36800-416-26368000416262 TUBE in 1 CARTON (36800-416-26) / 56 g in 1 TUBE2 tube2020-02-260000-00-00NoNoCurrent
36800-416-58368000416581 TUBE in 1 CARTON (36800-416-58) / 14.2 g in 1 TUBE1 tube2020-02-260000-00-00NoNoCurrent
36800-416-64368000416641 TUBE in 1 CARTON (36800-416-64) / 28 g in 1 TUBE1 tube2020-02-260000-00-00NoNoCurrent