FDA.reportPublic FDA data

Antibiotic

Product NDC
0363-0018
11-digit product format
003630018
Labeler code
0363
Product ID
0363-0018_90cc49be-ab46-49ab-9a70-7801eede73a0
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Walgreens
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-06-16
Marketing end
2027-01-31
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
Current FDA listing
Yes

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
Antibiotic
Brand name suffix
Maximum Strength

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1359363Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9a092f24-65b2-4b57-8103-265ea3e03311Available on FDA.report

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
0363-0018-56AntibioticMaximum Strength1 in 1 CARTONOINTMENT114
0363-0018-56AntibioticMaximum Strength28 g in 1 TUBEOINTMENT2814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0018-56GM - Gram0363-001850c12260-e560-4ddd-bf84-fa9344a46a8612021-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESANTIBIOTIC MAXIMUM STRENGTH (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WALGREEN COMPANY]3
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693ANTIBIOTIC MAXIMUM STRENGTH (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WALGREEN COMPANY]3
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4ANTIBIOTIC MAXIMUM STRENGTH (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WALGREEN COMPANY]3
BACITRACINACTIVE MOIETY58H6RWO52IANTIBIOTIC MAXIMUM STRENGTH (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WALGREEN COMPANY]3
NEOMYCINACTIVE MOIETYI16QD7X297ANTIBIOTIC MAXIMUM STRENGTH (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WALGREEN COMPANY]3
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KANTIBIOTIC MAXIMUM STRENGTH (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WALGREEN COMPANY]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UANTIBIOTIC MAXIMUM STRENGTH (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WALGREEN COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0018ANTIBIOTIC MAXIMUM STRENGTH (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WALGREENS]13Current NDC, Legacy NDC, 2 package rows20240627_9a092f24-65b2-4b57-8103-265ea3e03311.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
application number: M004
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
application number: M004

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 OintmentPSN9a092f24-65b2-4b57-8103-265ea3e0331114
1359363bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Topical OintmentSCD9a092f24-65b2-4b57-8103-265ea3e0331114
1359363bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Topical OintmentSY9a092f24-65b2-4b57-8103-265ea3e0331114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0018-56003630018561 TUBE in 1 CARTON (0363-0018-56) / 28 g in 1 TUBE1 tube1998-06-162027-01-31NoNoCurrent