FDA.reportPublic FDA data

triple antibiotic

Product NDC
0363-0539
11-digit product format
003630539
Labeler code
0363
Product ID
0363-0539_801aadf0-611d-4ea9-8015-3542dc981d5b
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin, polymyxin B
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Walgreen Company
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-05-07
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0539-16triple antibiotic56 g in 1 TUBEOINTMENT5612
0363-0539-16triple antibiotic1 in 1 CARTONOINTMENT112
0363-0539-26triple antibiotic56 g in 1 TUBEOINTMENT5612
0363-0539-26triple antibiotic2 in 1 CARTONOINTMENT212
0363-0539-64triple antibiotic1 in 1 CARTONOINTMENT112
0363-0539-64triple antibiotic28 g in 1 TUBEOINTMENT2812

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0539-58GM - Gram0363-05390d9403ce-b5c3-4cb4-b7fd-e04a2bc5c2ec12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]2
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]2
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]2
BACITRACINACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]2
NEOMYCINACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]2
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]2
COTTONSEED OILINACTIVE INGREDIENTH3E878020NTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1ETRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]2
SODIUM PYRUVATEINACTIVE INGREDIENTPOD38AIF08TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0539TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY]12Current NDC, Legacy NDC, 6 package rows20250305_4f3cfe39-2df8-48b4-954d-5997217c92ba.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 OintmentPSN4f3cfe39-2df8-48b4-954d-5997217c92ba12
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD4f3cfe39-2df8-48b4-954d-5997217c92ba12
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY4f3cfe39-2df8-48b4-954d-5997217c92ba12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0539-16003630539161 TUBE in 1 CARTON (0363-0539-16) / 56 g in 1 TUBE1 tube2015-08-290000-00-00NoNoCurrent
0363-0539-26003630539262 TUBE in 1 CARTON (0363-0539-26) / 56 g in 1 TUBE2 tube2015-11-240000-00-00NoNoCurrent
0363-0539-58003630539581 TUBE in 1 CARTON (0363-0539-58) > 14 g in 1 TUBE1 tube2015-08-260000-00-00NoNoCurrent
0363-0539-64003630539641 TUBE in 1 CARTON (0363-0539-64) > 28 g in 1 TUBE1 tube2015-05-070000-00-00NoNoCurrent