FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
68071-3754
11-digit product format
680713754
Labeler code
68071
Product ID
68071-3754_5b1449dd-e322-db49-e063-6394a90a0e5c
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
NuCare Pharmaceutical, 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
5b14499e-e45c-7c05-e063-6294a90a1cc2Available on FDA.report

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 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
application number: M004
GENUINE FIRST AID AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.23abfe12-5b50-4b49-878e-4fcdb6c341fd2023-10-19WarningsExact identifier
application number: M004
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3754-1680713754011 TUBE in 1 CARTON (68071-3754-1) / 28.4 g in 1 TUBE1 tube2026-09-09NoNoCurrent