FDA.reportPublic FDA data

Premier Value Triple Antibiotic

Product NDC
68016-320
11-digit product format
680160320
Labeler code
68016
Product ID
68016-320_29b70f22-a6e4-4c0b-e063-6294a90a8d1d
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc, Neomycin Sulfate, Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Premier Value Alliance LLC.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-10
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
2026-12-31
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
Premier Value Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [USP'U]/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
ab843664-a1e0-6716-e053-2995a90a2063Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-320-052023-05-09C16284748780-1f386c649-f086-0266-e053-dadaa90a7c1aPremier Value Triple Antibiotic Ointment
68016-320-052023-01-30C16284748780-1f386c649-f086-0266-e053-dadaa90a7c1aPremier Value Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-320-05Premier Value Triple Antibiotic1 in 1 BOXOINTMENT14
68016-320-05Premier Value Triple Antibiotic14 g in 1 TUBEOINTMENT144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-320PREMIER VALUE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [PREMIER VALUE ALLIANCE LLC.]4Current NDC, Legacy NDC, 2 package rows20241222_ab843664-a1e0-6716-e053-2995a90a2063.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 8 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GASCO ANTIBACTERIALBENZALKONIUM CHLORIDEGASCO INDUSTRIAL CORP411ffefe-16e5-a2e0-e063-6394a90a0cd42025-10-14WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC4124e9e2-397f-8921-e063-6394a90a5ffe2025-10-14WarningsExact identifier
application number: M004
AntibioticNEOMYCIN SULFATETotal Resources International0725364b-b243-4891-af2f-a6049366d0382025-10-10WarningsExact identifier
application number: M004
MediChoice BacitracinBACITRACINO&M HALYARD, INC.78079b94-c6fc-4529-aaad-8186924ecba52025-10-09WarningsExact identifier
application number: M004
MediChoice Triple AntibioticBACITRACINO&M HALYARD, INC.8369f399-6f64-4441-be72-1f16c7306c0a2025-10-09WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEMedline Industries, LP301ebb9a-033b-4f04-99ff-571e921924ca2025-10-09WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINCMedline Industries, LPf8282204-f9b9-486f-b18b-dc5ba85cce102025-10-09WarningsExact identifier
application number: M004
TheraCare Triple Antibiotic Pain ReliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINEVeridian Healthcarefaf73908-324f-27f5-e053-6394a90aa06e2025-10-02WarningsExact identifier
application number: M004
Viaderma Care First AidBACITRACIN ZINCViaDerma Distribution, Inc.dabb7ce8-3284-4dfc-bc6e-38a691be43c12025-10-02WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC POLYMYXIN B SULFATEEncube Ethicals, Inc.8f00b059-6729-4fae-8e8c-e14fe8838c592025-09-30WarningsExact identifier
application number: M004
Xpect Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECintas Corporation39355db3-24d7-485f-9ce0-f0e466e965932025-09-26WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE PRAMOXINE HCLEncube Ethicals, Inc.dfea6b2e-cd76-439d-a3da-64e2d87171632025-09-25WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEEncube Ethicals, Inc.2e985ad0-aa50-4c6b-b0af-1d61489a9fda2025-09-25WarningsExact identifier
application number: M004
Medi-First Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationf2f0a1da-3e33-3c1a-e053-2a95a90a12b12025-09-09WarningsExact identifier
application number: M004
Ecolab Triple AntibioticBACITRACIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEcolabs Food Safety Specialties, Inc.4aef8f98-db76-07f2-e054-00144ff8d46c2025-09-09WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationd265f094-e654-4c68-9215-b5d061af885d2025-09-08WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationd7c1a10e-c38d-4ae8-9a27-c07c2208ca842025-09-08WarningsExact identifier
application number: M004
Thompson Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEThompsonf883c4cb-c32c-76e3-e053-6294a90aa4fc2025-09-08WarningsExact identifier
application number: M004
Thompson Triple AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATEThompsonde9489de-e677-2bd3-e053-2a95a90acfb42025-09-08WarningsExact identifier
application number: M004
BACITRACIN ZINCFIRST AID ANTIBIOTICEncube Ethicals, Inc.613cbed4-9790-4e6b-a61b-b7b7a8ee59c92025-09-04WarningsExact 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 OintmentPSNab843664-a1e0-6716-e053-2995a90a20634
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDab843664-a1e0-6716-e053-2995a90a20634
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYab843664-a1e0-6716-e053-2995a90a20634

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-320-05680160320051 TUBE in 1 BOX (68016-320-05) / 14 g in 1 TUBE1 tube2019-01-100000-00-00NoNoCurrent