FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
0713-0268
11-digit product format
007130268
Labeler code
0713
Product ID
0713-0268_0cf1cf3a-c318-a32a-e063-6394a90a884d
Type
HUMAN OTC DRUG
Nonproprietary name
Polymyxin B Sulfate, Bacitracin Zinc and Neomycin Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-01-11
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

Additional Listing Data#

Finished product
Yes
Brand name base
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 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
0713-0268-312022-08-19C16284748780-19d75b9d1-0873-f424-e053-dadaa90a57ceTriple Antibiotic Ointment First Aid Antibiotic Ointment
0713-0268-312020-01-31C16284748780-19d75b9d1-0873-f424-e053-dadaa90a57ceTriple Antibiotic Ointment First Aid Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0268-31Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.43
0713-0268-31Triple Antibiotic1 in 1 CARTONOINTMENT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0268-31GM - Gram0713-026811922163-2c1a-4c42-8a3d-cbcd9eda8e9512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
NeomycinACTIVE INGREDIENTI16QD7X297TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
BacitracinACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
NeomycinACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPTRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC OINTMENT (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE) OINTMENT [G&W LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0268TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE) OINTMENT [COSETTE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20231221_39893365-c94f-bc83-67f6-0005d5f2aa24.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 OintmentPSNe115d413-e41c-4e43-8184-493d64dfcd9f16
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDe115d413-e41c-4e43-8184-493d64dfcd9f16
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYe115d413-e41c-4e43-8184-493d64dfcd9f16
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN39893365-c94f-bc83-67f6-0005d5f2aa243
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD39893365-c94f-bc83-67f6-0005d5f2aa243
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY39893365-c94f-bc83-67f6-0005d5f2aa243
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN524d65e7-9dc6-47b0-a924-46a765fa18692
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD524d65e7-9dc6-47b0-a924-46a765fa18692
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY524d65e7-9dc6-47b0-a924-46a765fa18692
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN0dfe5f6a-6968-68e6-e063-6294a90ae25b1
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD0dfe5f6a-6968-68e6-e063-6294a90ae25b1
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY0dfe5f6a-6968-68e6-e063-6294a90ae25b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0268-31007130268311 TUBE in 1 CARTON (0713-0268-31) / 28.4 g in 1 TUBE1 tube1995-01-110000-00-00NoNoCurrent