FDA.reportPublic FDA data

Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate

Product NDC
0404-0171
11-digit product format
004040171
Labeler code
0404
Product ID
0404-0171_5d41b051-4fd6-6334-e063-6394a90a76e4
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Henry Schein
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-04
Substance
POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC
Active strength
50000; 5; 400 [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

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
Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYMYXIN B SULFATE50000 [iU]/g
NEOMYCIN SULFATE5 mg/g
BACITRACIN ZINC400 [iU]/g

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
0404-0171-502024-01-31C16284748780-11030e365-0ab0-111a-e063-dadaa90a10e2570-3130 Triple Antibiotic NDC 0404-0171-50
0404-0171-502024-01-31C16284748780-11030e365-0ab0-111a-e063-dadaa90a10e2570-3130 Triple Antibiotic NDC 0404-0171-50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0171-50Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate72 in 1 CASEOINTMENT724
0404-0171-50Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate1 in 1 BOXOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0171BACITRACIN ZINC, POLYMYXIN B SULFATE, AND NEOMYCIN SULFATE OINTMENT [HENRY SCHEIN]3Current NDC, Legacy NDC, 2 package rows20241129_eadb847e-aefe-41cf-e053-2995a90af2cd.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 15 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neosporin Kids Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC6752f0a0-2432-4d8b-8198-74ae96a689632024-11-13WarningsExact identifier
application number: M004
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLCa3e6fe2e-1b74-4f22-9c7c-a000574396902024-11-13WarningsExact identifier
application number: M004
Neosporin Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC32302dcd-f3f1-408b-ae5f-e7d8b666f68f2024-11-13WarningsExact identifier
application number: M004
NEOSPORIN Plus BURN RELIEFBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC3caa7fd1-bd66-427e-a6c0-1b137b2050892024-11-13WarningsExact identifier
application number: M004
Simply Neosporin First Aid AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEKenvue Brands LLC68bfecea-095f-4d3f-b077-d86e1b9f1faa2024-11-13WarningsExact identifier
application number: M004
Triple Antibiotic and Burn ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDECVS Pharmacyfdc510b8-f3ad-4bd6-a8d0-1b81e9f30e132024-11-13WarningsExact identifier
application number: M004
BACITRACINBACITRACINALLIED TRADE LINK LLC253e5b98-c64f-3226-e063-6294a90a93522024-11-12WarningsExact identifier
application number: M004
TRIPLET ANTIBIOTICTRIPLET ANTIBIOTICALLIED TRADE LINK LLC26bd5ba4-264b-2a28-e063-6394a90ada802024-11-12WarningsExact identifier
application number: M004
basic care first aid antibiotic and burn reliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEAmazon.com Services LLC0df4c44d-6912-4db9-a703-a82da4c8ae762024-11-11WarningsExact identifier
application number: M004
SUPER SENSITIVE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTY7d4a5b21-82d2-4904-9577-4a9b2579076e2024-11-08WarningsExact identifier
application number: M004
dg health triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLDolgencorp, LLC4c97dada-966f-4de8-b5d9-e939cb456aea2024-11-06WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BA-S Medication Solutionsde07139e-ece9-424b-8468-f5ed4bbb2b2b2024-11-06WarningsExact identifier
application number: M004
good sense triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLL. Perrigo Companye9e913d8-8ec8-4465-ad3a-b524f6710a0f2024-11-06WarningsExact identifier
application number: M004
EUCALYPTUS EASE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTY09d77591-9472-4771-9090-3390bddf788a2024-11-06WarningsExact identifier
application number: M004
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATEA-S Medication Solutionse115d413-e41c-4e43-8184-493d64dfcd9f2024-11-06WarningsExact identifier
application number: M004
LEMON MYRTLE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTYf341b24c-9466-42f4-98fe-d1a1225919152024-11-06WarningsExact identifier
application number: M004
BacitracinBACITRACINA-S Medication Solutions00747e3a-389c-46bc-b6b9-9b3d1d98dbcf2024-11-06WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLSafeway46db4b66-85a2-47fc-a643-df6477e2ddff2024-11-06WarningsExact identifier
application number: M004
CALMING HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTYffcbe34d-3c53-47f9-9e4a-b5448afbbd5d2024-11-05WarningsExact identifier
application number: M004
Antibiotic, Pain and ScarBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLCVS Pharmacy8bb6cb64-103f-454a-95ad-c2c56b9cf71a2024-11-05WarningsExact identifier
application number: M004

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 OintmentPSNeadb847e-aefe-41cf-e053-2995a90af2cd4
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDeadb847e-aefe-41cf-e053-2995a90af2cd4
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYeadb847e-aefe-41cf-e053-2995a90af2cd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0171-500040401715072 BOX in 1 CASE (0404-0171-50) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE72 box2022-11-040000-00-00NoNoCurrent