FDA.reportPublic FDA data

Drs. Pharmacy Triple Antibiotic Plus

Product NDC
80489-757
11-digit product format
804890757
Labeler code
80489
Product ID
80489-757_2b5279c4-6ef3-23fd-e063-6394a90a1857
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
OL PHARMA TECH, LLC Drs PHARMACY
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-05
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
400; 3.5; 5000; 10 [USP'U]/1000mg; mg/1000mg; [USP'U]/1000mg; mg/1000mg
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
Drs. Pharmacy Triple Antibiotic Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [USP'U]/1000mg
NEOMYCIN SULFATE3.5 mg/1000mg
POLYMYXIN B SULFATE5000 [USP'U]/1000mg
PRAMOXINE HYDROCHLORIDE10 mg/1000mg

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1999890Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d037bfb8-0d8c-4eda-e053-2995a90ae1f2Available 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
80489-757-01Drs. Pharmacy Triple Antibiotic Plus14000 mg in 1 TUBEOINTMENT140004
80489-757-01Drs. Pharmacy Triple Antibiotic Plus1 in 1 CARTONOINTMENT14
80489-757-02Drs. Pharmacy Triple Antibiotic Plus1 in 1 CARTONOINTMENT14
80489-757-02Drs. Pharmacy Triple Antibiotic Plus28300 mg in 1 TUBEOINTMENT283004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-757DRS. PHARMACY TRIPLE ANTIBIOTIC PLUS (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE) OINTMENT [OL PHARMA TECH, LLC DRS PHARMACY]4Current NDC, Legacy NDC, 4 package rows20250112_d037bfb8-0d8c-4eda-e053-2995a90ae1f2.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 105 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guardian VaginalBENZALKONIUM CHLORIDEEastern Century Pharmaceuticals1605ba44-02b7-4c72-9fec-89a5aa962b442024-04-24WarningsExact identifier
application number: M003
Inverness Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.0ccd72e7-16a2-47c7-9ce6-dffb63a0344b2024-04-18WarningsExact identifier
application number: M003
Lovisa Piercing Care SolutionBENZALKONIUM CHLORIDEThe Richline Group, Inc.74f46b81-cc5b-4e3f-a36e-0bd86d370c222024-04-18WarningsExact identifier
application number: M003
CliniClean BZK Cleansing Contains Benzalkonium ChlorideBENZALKONIUM CHLORIDEHR HealthCareb6916466-0931-408f-a430-0797a449c32e2024-04-18WarningsExact identifier
application number: M003
Handy Solutions First Aid KitBENZALKONIUM CHLORIDENavajo Manufacturing Company Inc.130237ff-3db4-1288-e063-6394a90ab1af2024-04-16WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEHenry Schein Inc.ff877b63-fa58-4770-a882-694eda33203b2024-04-02WarningsExact identifier
application number: M003
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine HydrochlorideBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.8e1f35ff-d4e6-4940-ad8f-dce2b73e595d2024-04-01WarningsExact identifier
application number: M003
Antiseptic Towelette TOALLITAS ANTISEPTICASBENZALKONIUM CHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.b267e186-cf7a-458f-9c28-a48a8554af402024-04-01WarningsExact identifier
application number: M003
Antiseptic Povidone Iodine Prep PadPOVIDONE-IODINEM-star (Hubei) Health&Care Products Co., Ltd.fc76c1f3-b48e-4276-890d-5b8e5a894e622024-04-01WarningsExact identifier
application number: M003
Novex Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.8b53dde5-c9f6-41c4-8ddb-bf0bf67008d32024-03-20WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDE 0.13%Trifecta Pharmaceuticals USA, LLC.13f1c70f-3b44-8eef-e063-6294a90af6342024-03-18WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC1308ce91-2858-310a-e063-6394a90a68102024-03-06WarningsExact identifier
application number: M003
Instant Hand Sanitizer - Cocoa ButterETHYL ALCOHOLRejoice International, Inc.97dee45e-53be-4b37-a427-fc24388c0e052024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer Aloe VeraETHYL ALCOHOLRejoice International, Inc.1e28454c-f5d8-4d6e-91f9-bc4501b027c12024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - ClearETHYL ALCOHOLRejoice International, Inc.f0e637d9-d61e-466d-9e05-f906639dbaca2024-02-28WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International, Inc.07b163e4-8f67-44e7-b5ef-f237023080e02024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - Ice ClearETHYL ALCOHOLRejoice International, Inc.605ec88a-2f4c-4716-8522-eb2748b433982024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - OriginalETHYL ALCOHOLRejoice International, Inc.bb9cc886-275e-4996-99dc-529f928b49052024-02-28WarningsExact identifier
application number: M003
Liquid Hand CleanseTRICLOSANRejoice International, Inc.23ff5450-8308-41c0-9052-1ac4c4433d6c2024-02-28WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse OriginalTRICLOSANRejoice International, Inc.b5ce6663-fe82-4da1-923e-acea293d7a002024-02-28WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999890bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentPSNd037bfb8-0d8c-4eda-e053-2995a90ae1f24
1999890bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCDd037bfb8-0d8c-4eda-e053-2995a90ae1f24
1999890bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5,000 UNT / pramoxine hydrochloride 10 MG per GM Topical OintmentSYd037bfb8-0d8c-4eda-e053-2995a90ae1f24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80489-757-01804890757011 TUBE in 1 CARTON (80489-757-01) / 14000 mg in 1 TUBE1 tube2021-09-050000-00-00NoNoCurrent
80489-757-02804890757021 TUBE in 1 CARTON (80489-757-02) / 28300 mg in 1 TUBE1 tube2021-09-050000-00-00NoNoCurrent