FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
51672-2120
11-digit product format
516722120
Labeler code
51672
Product ID
51672-2120_534599e8-fece-b9dc-e063-6294a90ad09a
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-15
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [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
Triple Antibiotic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [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
204602Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d77239e6-5e81-439a-b0cd-f8be59169442Available 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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
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
51672-2120-1Triple Antibiotic1 in 1 CARTONOINTMENT15
51672-2120-1Triple Antibiotic14.2 g in 1 TUBEOINTMENT14.25
51672-2120-2Triple Antibiotic1 in 1 CARTONOINTMENT15
51672-2120-2Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.45
51672-2120-3Triple Antibiotic60 g in 1 TUBEOINTMENT605
51672-2120-3Triple Antibiotic1 in 1 CARTONOINTMENT15
51672-2120-6Triple Antibiotic0.9 g in 1 APPLICATOROINTMENT0.95
51672-2120-6Triple Antibiotic6 in 1 CARTONOINTMENT65
51672-2120-8Triple Antibiotic0.9 g in 1 APPLICATOROINTMENT0.95
51672-2120-8Triple Antibiotic15 in 1 CARTONOINTMENT155
51672-2120-9Triple Antibiotic144 in 1 CARTONOINTMENT1445
51672-2120-9Triple Antibiotic0.9 g in 1 APPLICATOROINTMENT0.95

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2120-1GM - Gram51672-2120161fa1c5-9889-4d4d-b06e-da422f00f3a312016-05-16
51672-2120-2GM - Gram51672-212044e5c044-5369-45b0-b1d4-5711f5d65f7412016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2120TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 12 package rows20240427_d77239e6-5e81-439a-b0cd-f8be59169442.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 14 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Antibiotic plus Burn ReliefBACITRACINZINC,NEOMYCINSULFATE,POLYMXINBSULFATE,PRAMOXINEHCITrifecta Pharmaceuticals USA LLC048871e2-c917-292d-e063-6394a90af1302024-12-18WarningsExact identifier
application number: M004
TheraCare Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEVeridian Healthcare0c3fc798-9a97-5316-e063-6394a90a68302024-12-18WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCRugby Laboratoriesac3c9897-c812-1360-e053-2a95a90ad5912024-12-17WarningsExact identifier
application number: M004
Major BacitracinBACITRACIN ZINCMajor Pharmaceuticalsa23ce772-7078-0a4b-e053-2995a90aff0d2024-12-17WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLCeea0d90c-914b-2624-e053-2a95a90a34c92024-12-13WarningsExact identifier
application number: M004
OP First Aid Series TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.cadebf07-dd48-4855-8296-7a91e28d71232024-12-05WarningsExact identifier
application number: M004
triple antibiotic and pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDECVS Pharmacyf0864d78-23e6-4e6c-bc67-7ba3e6dd862c2024-12-03WarningsExact identifier
application number: M004
triple antibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEPublix Super Markets Inc330c7b7a-d0d1-42dc-b8f7-9c96aeaf69f92024-11-25WarningsExact identifier
application number: M004
WinCo Maximum Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDEWinCo Foods, LLC01b03c7e-6c4e-43aa-8480-aff1c2688f7f2024-11-21WarningsExact identifier
application number: M004
WinCo Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEWinCo Foods, LLCe364b623-6e20-4894-8d4c-5c739be78f862024-11-21WarningsExact identifier
application number: M004
Winco Bacitracin ZincBACITRACIN ZINCWinCo Foods, LLCdcdf647f-fa32-4b72-b714-a77e8e3323582024-11-21WarningsExact identifier
application number: M004
Walgreens Multi-Antibiotic with Pain Relief CreamPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDEWalgreens Companyf4feccc3-ac25-4d8a-9b68-9a24f755524a2024-11-20WarningsExact identifier
application number: M004
Walgreens Kids Multi-Antibiotic with Pain Relief CreamPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDEWalgreens Companyfbc364d7-d8b8-43f5-99cc-290438f3982b2024-11-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAcme United Corporationf9a48f73-aa12-cf68-e053-6294a90a8e532024-11-19WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEAcme United Corporatione55cbf7e-c955-7f1a-e053-2a95a90a3f282024-11-19WarningsExact identifier
application number: M004
First Aid Only Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAcme United Corporationf4eba34c-ce31-3004-e053-2995a90a245b2024-11-19WarningsExact identifier
application number: M004
First Aid Only Neomycin AntibioticNEOMYCIN SULFATEAcme United Corporationc651e98e-aabe-de46-e053-2a95a90a63072024-11-19WarningsExact identifier
application number: M004
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLCf07d3bca-4312-46ed-b0c4-f886c01bd0952024-11-14WarningsExact identifier
application number: M004
Polysporin First Aid AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEKenvue Brands LLCe0fcf83e-a374-4fc0-a629-8730330543922024-11-14WarningsExact identifier
application number: M004
Neosporin Pain Itch ScarBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC55392c48-b5d8-44cd-8c10-6d86683498482024-11-13WarningsExact 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 OintmentPSNd77239e6-5e81-439a-b0cd-f8be591694425
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDd77239e6-5e81-439a-b0cd-f8be591694425
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYd77239e6-5e81-439a-b0cd-f8be591694425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2120-1516722120011 TUBE in 1 CARTON (51672-2120-1) / 14.2 g in 1 TUBE1 tube2015-12-150000-00-00NoNoCurrent
51672-2120-2516722120021 TUBE in 1 CARTON (51672-2120-2) / 28.4 g in 1 TUBE1 tube2015-12-150000-00-00NoNoCurrent
51672-2120-3516722120031 TUBE in 1 CARTON (51672-2120-3) / 60 g in 1 TUBE1 tube2015-12-150000-00-00NoNoCurrent
51672-2120-6516722120066 APPLICATOR in 1 CARTON (51672-2120-6) / .9 g in 1 APPLICATOR6 applicator2021-09-200000-00-00NoNoCurrent
51672-2120-85167221200815 APPLICATOR in 1 CARTON (51672-2120-8) / .9 g in 1 APPLICATOR15 applicator2021-09-200000-00-00NoNoCurrent
51672-2120-951672212009144 APPLICATOR in 1 CARTON (51672-2120-9) / .9 g in 1 APPLICATOR144 applicator2021-09-200000-00-00NoNoCurrent