FDA.reportPublic FDA data

Triple Antibiotic Plus Pain Relief

Product NDC
37835-904
11-digit product format
378350904
Labeler code
37835
Product ID
37835-904_404f4e7c-5776-71ba-e063-6394a90a73e5
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bi-Mart
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-01
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
400 [USP'U]/g; 5 mg/g; 10000 [USP'U]/g; 10 mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC]; Aminoglycosides [CS]; Decreased Cell Wall Synthesis & Repair [PE]; Polymyxin-class Antibacterial [EPC]; Polymyxins [CS]
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37835-904EExcluded after deficient or non-compliant submission was not corrected2026-10-12
excluded packagepackage37835-90437835-904-01EExcluded after deficient or non-compliant submission was not corrected2026-10-12

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 Plus Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [USP'U]/g
NEOMYCIN SULFATE5 mg/g
POLYMYXIN B SULFATE10000 [USP'U]/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
031725ab-4e9a-48c4-86a4-7c6ba1d996e6Available 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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37835-904-01Triple Antibiotic Plus Pain Relief1 in 1 CARTONOINTMENT13
37835-904-01Triple Antibiotic Plus Pain Relief28.4 g in 1 TUBEOINTMENT28.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37835-904TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [BI-MART]22 package rows20241201_031725ab-4e9a-48c4-86a4-7c6ba1d996e6.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 3 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi First Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporation545fa5b6-781c-18ae-e063-6294a90a2f0d2026-06-16WarningsExact identifier
application number: M004
Triple AntibioticFIRST AID ANTIBIOTIC ORIGINAL STRENGTHAldermed Inc.19eace87-b505-4be6-93b3-db5323e342162026-06-12WarningsExact identifier
application number: M004
BacitracinBACITRACINAlderMed Inc.3f0eb4a0-f7bf-45f7-8885-92c65a4bd8992026-06-08WarningsExact identifier
application number: M004
Bacitracin ZincFIRST AID ANTIBIOTICAldermed Inc.7f4bff4f-588d-4e45-8aa3-f95b4d746f252026-06-08WarningsExact identifier
application number: M004
Triple Antibiotic First Aid Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLAldermed Inc.5bfc7776-1030-48ba-9df4-897c4984c9e62026-06-08WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.4545c043-8e8e-4288-b4d8-e6ec9d72f9792026-06-04WarningsExact identifier
application number: M004
First Aid Kit, Orazen Inc5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTSOrazen Inc525bcb89-af5b-8652-e063-6294a90a41a62026-06-03WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESun Pharmaceutical Industries, Inc.d77239e6-5e81-439a-b0cd-f8be591694422026-06-02WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BHyVee Inc3ac9f0fc-e08c-49d9-9079-3ba0393c612b2026-06-02WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLHyVee Inc69a4b642-b7ec-43cc-aa57-6858da0b3d632026-06-02WarningsExact identifier
application number: M004
Careland Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPlanet (Anhui) Pharmaceutical Co., Ltd.0e64179d-fce2-48fc-833e-ce43a54b987c2026-05-31WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHubei Fanjian Medical Product Co.,Ltdf44ab989-c618-1831-e053-2995a90adc8e2026-05-28WarningsExact identifier
application number: M004
Vitastem-tetracycline hydrochlorideTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.7ffe82a4-864b-48c7-9307-d262f20ca01e2026-05-26WarningsExact identifier
application number: M004
Viaderma Vitastem First Aid Topical AntibioticTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC6eb04a76-7995-4df6-9c9b-dd450537e5382026-05-26WarningsExact identifier
application number: M004
Medi-First Bacitracin ZincBACITRACINUnifirst First Aid Corporation54609a4f-0fe9-b750-e063-6394a90ae9ce2026-05-26WarningsExact identifier
application number: M004
Hand SanALCOHOLRochester Midland Corporation2d89982d-d1fd-4a98-8b44-c2ae3545be582026-05-14WarningsExact identifier
application number: M004
first aid antibioticBACITRACINHyVee Inc97c87111-260a-48d0-92cd-e22f55a48c7d2026-05-12WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens Co.32df5cca-77bc-45d2-b1f6-2cfdfc371ea92026-05-12WarningsExact identifier
application number: M004
ANTIBIOTIC Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens Co.653c88bf-5b7d-45be-a131-d59990573e9c2026-05-12WarningsExact identifier
application number: M004
Fresh StartCHLOROXYLENOLPro Chem, Inc.dd1708d8-0bb2-c96a-e053-2995a90a5b862026-05-11WarningsExact identifier
application number: M004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
37835-904-01378350904011 TUBE in 1 CARTON (37835-904-01) / 28.4 g in 1 TUBE1 tube2024-07-010Current