FDA.reportPublic FDA data

TRIPLE ANTIBIOTIC

Product NDC
67234-031
11-digit product format
672340031
Labeler code
67234
Product ID
67234-031_865377a7-e51c-403a-8e64-0ad7da8623dc
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC, NEOMYCIN SULFATE, and POLYMYXIN B SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Natureplex LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-03
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 U/9.4g; mg/9.4g; U/9.4g
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
2027-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N000004-004PAREDRINEHYDROXYAMPHETAMINE HYDROBROMIDE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENatureplex LLCfbb64891-2219-451d-96b0-e7c0430fadda2026-02-12WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only. Do not use if you are allergic to any of the ingredients in the eyes over large areas of the body Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Additional Listing Data#

Finished product
Yes
Brand name base
TRIPLE ANTIBIOTIC
Brand name suffix
FIRST AID ANTIBIOTIC
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 U/9.4g
NEOMYCIN SULFATE3.5 mg/9.4g
POLYMYXIN B SULFATE5000 U/9.4g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4
Rxcui204602

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67234-031-012026-01-29C16284748780-149896155-c09a-586f-e063-e6dba90add90TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC
67234-031-022026-01-29C16284748780-149896155-c09a-586f-e063-e6dba90add90TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-031-01TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC9.4 g in 1 TUBEOINTMENT9.46
67234-031-01TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC1 in 1 CARTONOINTMENT16
67234-031-02TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC1 in 1 CARTONOINTMENT16
67234-031-02TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC28 g in 1 TUBEOINTMENT286
67234-031-03TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC1 in 1 CARTONOINTMENT16
67234-031-03TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC14 g in 1 TUBEOINTMENT146

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67234-031-01GM - Gram67234-0311d06785f-0389-4b50-a56b-ceaabdcecb5112024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [NATUREPLEX LLC]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [NATUREPLEX LLC]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [NATUREPLEX LLC]1
BACITRACINACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [NATUREPLEX LLC]1
NEOMYCINACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [NATUREPLEX LLC]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [NATUREPLEX LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [NATUREPLEX LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-031TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [NATUREPLEX LLC]5Current NDC, Legacy NDC, 6 package rows20250101_fbb64891-2219-451d-96b0-e7c0430fadda.zip

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 OintmentPSNfbb64891-2219-451d-96b0-e7c0430fadda6
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDfbb64891-2219-451d-96b0-e7c0430fadda6
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYfbb64891-2219-451d-96b0-e7c0430fadda6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67234-031-01672340031011 TUBE in 1 CARTON (67234-031-01) / 9.4 g in 1 TUBE1 tube2011-08-030000-00-00NoNoCurrent
67234-031-02672340031021 TUBE in 1 CARTON (67234-031-02) / 28 g in 1 TUBE1 tube2021-09-270000-00-00NoNoCurrent
67234-031-03672340031031 TUBE in 1 CARTON (67234-031-03) / 14 g in 1 TUBE1 tube2022-12-05NoNoCurrent