FDA.reportPublic FDA data

Drs. Pharmacy Triple Antibiotic AND BURN RELIEF

Product NDC
80489-919
11-digit product format
804890919
Labeler code
80489
Product ID
80489-919_4928d0c5-0313-dfd6-e063-6394a90ab798
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, polymyxin b sulfate
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 AND BURN 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
4928d9dd-542b-fe8b-e063-6294a90a9252Available 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
80489-919-01Drs. Pharmacy Triple Antibiotic AND BURN RELIEF14000 mg in 1 TUBEOINTMENT140001
80489-919-01Drs. Pharmacy Triple Antibiotic AND BURN RELIEF1 in 1 CARTONOINTMENT11
80489-919-02Drs. Pharmacy Triple Antibiotic AND BURN RELIEF28300 mg in 1 TUBEOINTMENT283001
80489-919-02Drs. Pharmacy Triple Antibiotic AND BURN RELIEF1 in 1 CARTONOINTMENT11

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 100 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl Rubbing Alcohol 50% with WintergreenISOPROPYL ALCOHOLUniversal Distribution Center LLC0b185535-b1af-4128-89ca-65b0e63cd4302024-10-21WarningsExact identifier
application number: M003
HAND SANITIZER RAINFALLALCOHOLSCENT THEORY PRODUCTS LLC24b1a25c-a3b6-9278-e063-6394a90a3ae22024-10-17WarningsExact identifier
application number: M003
HAND SANITIZER RASPBERRY MANGOALCOHOLSCENT THEORY PRODUCTS LLC24b19489-4e59-0df8-e063-6394a90af6ae2024-10-17WarningsExact identifier
application number: M003
HAND SANITIZER BRAZILIAN COCONUTALCOHOLSCENT THEORY PRODUCTS LLC24b1992a-d695-32b2-e063-6394a90a6cab2024-10-17WarningsExact identifier
application number: M003
HAND SANITIZER LUSH ALOEALCOHOLSCENT THEORY PRODUCTS LLC24b1a25c-a3b8-9278-e063-6394a90a3ae22024-10-17WarningsExact identifier
application number: M003
CICLOFERONBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDELaboratorios Liomont, S.A. de C.V.89081ef8-9721-a476-e053-2995a90ae0de2024-10-17WarningsExact identifier
application number: M003
Bebesup Antibacterial Handy WipesBENZALKONIUM CHLORIDEAJ Co., Ltd.24b75970-5138-ce50-e063-6394a90a123c2024-10-17WarningsExact identifier
application number: M003
HAND SANITIZER SANDALWOOD WAVESALCOHOLSCENT THEORY PRODUCTS LLC24893800-464a-16ca-e063-6294a90a90652024-10-16WarningsExact identifier
application number: M003
First Aid Only BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEAcme United Corporationc927f845-1383-ae85-e053-2995a90a12fc2024-10-15WarningsExact identifier
application number: M003
First Aid Only BZK AntisepticBENZALKONIUM CHLORIDEAcme United Corporationdbed7ed6-a9b8-7b59-e053-2a95a90ac0cb2024-10-15WarningsExact identifier
application number: M003
HILL COUNTRY FARE HAND SANITIZER WITH ALOE FRAGRANCEALCOHOLH.E.Bc89b48e9-1746-874b-e053-2995a90ab0712024-10-15WarningsExact identifier
application number: M003
HEB Citrus Hand SanitizerALCOHOLH.E.B.c8ab20e5-6a20-5a6b-e053-2a95a90a247c2024-10-15WarningsExact identifier
application number: M003
Instant Hand Sanitizing WipeETHYL ALCOHOLMcKesson9f51a505-2d55-5c49-e053-2a95a90a24032024-10-14WarningsExact identifier
application number: M003
SwabPOVIDONE-IODINEMcKesson Medical-Surgical Inc.4777b5f4-1698-08da-e054-00144ff8d46c2024-10-14WarningsExact identifier
application number: M003
Walgreens Sunburn ReliefLIDOCAINE HYDROCHLORIDEWALGREEN COMPANYd4c9913d-fcac-4785-e053-2995a90a79172024-10-14WarningsExact identifier
application number: M003
Target Up and Up 2-in-1 Hand SanitizerBENZETHONIUM CHLORIDETARGET CORPORATIONe069c9e6-024d-5482-e053-2995a90a767d2024-10-14WarningsExact identifier
application number: M003
Meridian Wrapped antibacterial DeodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.7c834c1d-7930-4909-a600-6de9698e2b172024-10-14WarningsExact identifier
application number: M003
Meridian Unwrapped antibacterial DeodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.adc10d22-a913-4bfa-a3f7-d6d5778f07ca2024-10-14WarningsExact identifier
application number: M003
First Aid Antiseptic Pain RelievingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEHubei Changjian Medical Products Co., Ltd.9cb3759a-35d9-4f6b-94ad-fafd4bc600bd2024-10-11WarningsExact identifier
application number: M003
Antiseptic ToweletteBENZALKONIUM CHLORIDEHubei Changjian Medical Products Co., Ltd.bf045881-9636-4000-a0ac-f6aab6b818322024-10-11WarningsExact 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 OintmentPSN4928d9dd-542b-fe8b-e063-6294a90a92521
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD4928d9dd-542b-fe8b-e063-6294a90a92521
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY4928d9dd-542b-fe8b-e063-6294a90a92521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80489-919-01804890919011 TUBE in 1 CARTON (80489-919-01) / 14000 mg in 1 TUBE1 tube2021-09-05NoNoCurrent
80489-919-02804890919021 TUBE in 1 CARTON (80489-919-02) / 28300 mg in 1 TUBE1 tube2021-09-05NoNoCurrent