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

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 tube2022-12-05NoNoHistorical