FDA.reportPublic FDA data

Drs. Pharmacy Triple Antibiotic Plus Pain relief

Product NDC
80489-857
11-digit product format
804890857
Labeler code
80489
Product ID
80489-857_5636791e-1403-2455-e063-6394a90a87fc
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
500; 3.5; 10000; 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
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
Drs. Pharmacy Triple Antibiotic Plus Pain relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/1000mg
NEOMYCIN SULFATE3.5 mg/1000mg
POLYMYXIN B SULFATE10000 [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
1359350Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1626fa89-cec0-6467-e063-6294a90aa2a4Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
80489-857-011626fa89-cec0-6467-e063-6294a90aa2a4
80489-857-011626fa89-cec0-6467-e063-6294a90aa2a4
80489-857-021626fa89-cec0-6467-e063-6294a90aa2a4
80489-857-021626fa89-cec0-6467-e063-6294a90aa2a4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-857-01Drs. Pharmacy Triple Antibiotic Plus Pain relief1 in 1 CARTONOINTMENT11
80489-857-01Drs. Pharmacy Triple Antibiotic Plus Pain relief14000 mg in 1 TUBEOINTMENT140001
80489-857-02Drs. Pharmacy Triple Antibiotic Plus Pain relief28300 mg in 1 TUBEOINTMENT283001
80489-857-02Drs. Pharmacy Triple Antibiotic Plus Pain relief1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-857DRS. PHARMACY TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE) OINTMENT [OL PHARMA TECH, LLC DRS PHARMACY]1Current NDC, 4 package rows20240418_1626fa89-cec0-6467-e063-6294a90aa2a4.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 98 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dynarex GreenALCOHOLDynarex Corporation072572be-49dd-4594-bc40-b56db57ada5b2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenCHLOROXYLENOLDynarex Corporation59b098d2-08de-4fdb-a209-ae226abf37d62024-11-20WarningsExact identifier
application number: M003
Baby WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsExact identifier
application number: M003
Pet wipesBENZALKONIUM CHLORIDEShandong Yayun Sanitary Products Co., Ltd.2764ea79-32d8-b7f6-e063-6394a90a55012024-11-20WarningsExact identifier
application number: M003
Premium Hand SanitizerETHANOLMCKESSON MEDICAL-SURGICAL INC.a9514466-e0c6-4792-984a-9f07d94ee8872024-11-18WarningsExact identifier
application number: M003
MARVEL BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.93ed0bb4-834d-44ca-9c0a-20086fc09ab82024-11-18WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.98b0bcc2-539b-4471-ba98-bbe17bb881bd2024-11-15WarningsExact identifier
application number: M003
CVS Health Hydrogen Peroxide WipesHYDROGEN PEROXIDECVS PHARMACY, INC7a930a5e-5b69-428f-9cbb-d03dae1802952024-11-12WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine Prep PadPOVIDONE-IODINEAcme United Corporation509b6c8e-6a9f-2656-e054-00144ff8d46c2024-11-09WarningsExact identifier
application number: M003
MED NAP Cleansing ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd92cd45a-234c-4872-e053-2a95a90a3e1c2024-11-09WarningsExact identifier
application number: M003
MED NAP Obstetrical ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd83d2fab-6972-9b18-e053-2995a90a5cb52024-11-09WarningsExact identifier
application number: M003
MED NAP Benzalkonium Chloride AntisepticBENZALKONIUM CHLORIDEAcme United Corporationd7c404c1-c765-a67c-e053-2995a90a6b8e2024-11-09WarningsExact identifier
application number: M003
Barbie BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.d675eb91-80a8-4874-a2b0-c2bf692649112024-11-08WarningsExact identifier
application number: M003
Barbie ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.a4a6beb0-5781-4d74-9120-7ca64e035c232024-11-08WarningsExact identifier
application number: M003
MARVEL ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.f6cd4757-d6e0-46bd-827f-3f380c71858f2024-11-07WarningsExact identifier
application number: M003
Instant Hand SanitizerHAND SANITIZERRaining Rose, Inc.2656d129-df88-4489-e063-6394a90a4b492024-11-07WarningsExact identifier
application number: M003
HealthWise Advanced Hand SanitizerETHYL ALCOHOL 70%Veridian Healthcare261bd056-c2f9-2a69-e063-6394a90af8df2024-11-04WarningsExact identifier
application number: M003
Hand Sanitizer Cucumber AloeORGANIC ETHYL ALCOHOLWhole Foods Market, Inc.0588ae1b-f29a-e1b6-e063-6394a90a0de12024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer Cucumber AloeETHYL ALCOHOLWhole Foods Market, Inc.074334af-c26e-4126-e063-6394a90ae4c42024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer Orange BlossomORGANIC ETHYL ALCOHOLWhole Foods Market, Inc.07f708d1-11c8-eb50-e063-6294a90a3a812024-11-02WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN1626fa89-cec0-6467-e063-6294a90aa2a41
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD1626fa89-cec0-6467-e063-6294a90aa2a41
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY1626fa89-cec0-6467-e063-6294a90aa2a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80489-857-01804890857011 TUBE in 1 CARTON (80489-857-01) / 14000 mg in 1 TUBE1 tube2021-09-05NoNoCurrent
80489-857-02804890857021 TUBE in 1 CARTON (80489-857-02) / 28300 mg in 1 TUBE1 tube2021-09-05NoNoCurrent