FDA.reportPublic FDA data

ANTIBIOTIC

Product NDC
0363-1331
11-digit product format
003631331
Labeler code
0363
Product ID
0363-1331_d74dbb9e-5f35-46ea-9bdc-70e19d0ec0cb
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Walgreens Co.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-29
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
500; 3.5; 10000 [iU]/g; mg/g; [iU]/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

Additional Listing Data#

Finished product
Yes
Brand name base
ANTIBIOTIC
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [iU]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4
Rxcui1359363

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
0363-1331-01ANTIBIOTICMaximum Strength1 in 1 CARTONOINTMENT12
0363-1331-01ANTIBIOTICMaximum Strength28 g in 1 TUBEOINTMENT282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1331ANTIBIOTIC MAXIMUM STRENGTH (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WALGREENS CO.]1Current NDC, 2 package rows20250212_653c88bf-5b7d-45be-a131-d59990573e9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359363bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Topical OintmentPSN653c88bf-5b7d-45be-a131-d59990573e9c2
1359363bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Topical OintmentSCD653c88bf-5b7d-45be-a131-d59990573e9c2
1359363bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Topical OintmentSY653c88bf-5b7d-45be-a131-d59990573e9c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-1331-01003631331011 TUBE in 1 CARTON (0363-1331-01) / 28 g in 1 TUBE1 tube2025-01-29NoNoCurrent