Home NDC 0363-0539 triple antibiotic
Product NDC 0363-0539
11-digit product format 003630539
Labeler code 0363
Product ID 0363-0539_9aca2de8-106b-49dc-9aa3-bba16b33be39
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 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 400 [USP'U]/g NEOMYCIN SULFATE 3.5 mg/g POLYMYXIN B SULFATE 5000 [USP'U]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 89Y4M234ES Internal UNII lookup 057Y626693 Internal UNII lookup 19371312D4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204602 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-0539-16 triple antibiotic 56 g in 1 TUBE OINTMENT 56 12 0363-0539-16 triple antibiotic 1 in 1 CARTON OINTMENT 1 12 0363-0539-26 triple antibiotic 56 g in 1 TUBE OINTMENT 56 12 0363-0539-26 triple antibiotic 2 in 1 CARTON OINTMENT 2 12 0363-0539-64 triple antibiotic 1 in 1 CARTON OINTMENT 1 12 0363-0539-64 triple antibiotic 28 g in 1 TUBE OINTMENT 28 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BACITRACIN ZINC ACTIVE INGREDIENT 89Y4M234ES TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY] 2 NEOMYCIN SULFATE ACTIVE INGREDIENT 057Y626693 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY] 2 POLYMYXIN B SULFATE ACTIVE INGREDIENT 19371312D4 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY] 2 BACITRACIN ACTIVE MOIETY 58H6RWO52I TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY] 2 NEOMYCIN ACTIVE MOIETY I16QD7X297 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY] 2 POLYMYXIN B ACTIVE MOIETY J2VZ07J96K TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY] 2 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY] 2 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY] 2 COTTONSEED OIL INACTIVE INGREDIENT H3E878020N TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY] 2 OLIVE OIL INACTIVE INGREDIENT 6UYK2W1W1E TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY] 2 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY] 2 SODIUM PYRUVATE INACTIVE INGREDIENT POD38AIF08 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0539 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [WALGREEN COMPANY] 12 Current NDC, Legacy NDC, 6 package rows 20250305_4f3cfe39-2df8-48b4-954d-5997217c92ba.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 · 422 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-0539-16 00363053916 1 TUBE in 1 CARTON (0363-0539-16) > 56 g in 1 TUBE 1 tube 2015-08-29 0000-00-00 No No Current 0363-0539-26 00363053926 2 TUBE in 1 CARTON (0363-0539-26) > 56 g in 1 TUBE 2 tube 2015-11-24 0000-00-00 No No Current 0363-0539-58 00363053958 1 TUBE in 1 CARTON (0363-0539-58) > 14 g in 1 TUBE 1 tube 2015-08-26 0000-00-00 No No Current 0363-0539-64 00363053964 1 TUBE in 1 CARTON (0363-0539-64) / 28 g in 1 TUBE 1 tube 2015-05-07 0000-00-00 No No Current