FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
0924-5604
11-digit product format
009245604
Labeler code
0924
Product ID
0924-5604_27495546-006d-ad90-e063-6394a90a71ce
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Acme United Corporation
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-24
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [iU]/g; mg/g; [iU]/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
Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [iU]/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
f9a48f73-aa12-cf68-e053-6294a90a8e53Available 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
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
0924-5604-00Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.52
0924-5604-01Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.52
0924-5604-01Triple Antibiotic6 in 1 BAGOINTMENT62
0924-5604-02Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.52
0924-5604-02Triple Antibiotic10 in 1 BOXOINTMENT102
0924-5604-03Triple Antibiotic12 in 1 BOXOINTMENT122
0924-5604-03Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.52
0924-5604-04Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.52
0924-5604-04Triple Antibiotic20 in 1 BOXOINTMENT202
0924-5604-05Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.52
0924-5604-05Triple Antibiotic25 in 1 BOXOINTMENT252
0924-5604-06Triple Antibiotic60 in 1 BOXOINTMENT602
0924-5604-06Triple Antibiotic0.5 g in 1 PACKETOINTMENT0.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5604TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]2Current NDC, 13 package rows20241121_f9a48f73-aa12-cf68-e053-6294a90a8e53.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 OintmentPSNf9a48f73-aa12-cf68-e053-6294a90a8e532
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDf9a48f73-aa12-cf68-e053-6294a90a8e532
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYf9a48f73-aa12-cf68-e053-6294a90a8e532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0924-5604-0000924560400.5 g in 1 POUCH (0924-5604-00) 2023-04-24NoNoCurrent
0924-5604-01009245604016 POUCH in 1 BAG (0924-5604-01) / .5 g in 1 POUCH6 pouch2023-04-24NoNoCurrent
0924-5604-020092456040210 PACKET in 1 BOX (0924-5604-02) / .5 g in 1 PACKET10 packet2023-04-24NoNoCurrent
0924-5604-030092456040312 POUCH in 1 BOX (0924-5604-03) / .5 g in 1 POUCH12 pouch2023-04-24NoNoCurrent
0924-5604-040092456040420 PACKET in 1 BOX (0924-5604-04) / .5 g in 1 PACKET20 packet2023-04-24NoNoCurrent
0924-5604-050092456040525 PACKET in 1 BOX (0924-5604-05) / .5 g in 1 PACKET25 packet2023-04-24NoNoCurrent
0924-5604-060092456040660 PACKET in 1 BOX (0924-5604-06) / .5 g in 1 PACKET60 packet2023-04-24NoNoCurrent