FDA.reportPublic FDA data

WinCo Maximum Strength Triple Antibiotic

Product NDC
67091-272
11-digit product format
670910272
Labeler code
67091
Product ID
67091-272_0e236329-0e8a-4e32-ab3b-fb2ffc94995c
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Poymyxin B Sulfate, and Pramoxine Hydrochrloride
Dosage form
OINTMENT
Route
TOPICAL
Labeler
WinCo Foods, LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-10
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/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
2026-12-31
Current FDA listing
Yes

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
67091-272-28WinCo Maximum Strength Triple Antibiotic28 g in 1 TUBEOINTMENT287
67091-272-28WinCo Maximum Strength Triple Antibiotic1 in 1 CARTONOINTMENT17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESWINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE) OINTMENT [WINCO FOODS, LLC]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693WINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE) OINTMENT [WINCO FOODS, LLC]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4WINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE) OINTMENT [WINCO FOODS, LLC]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5WINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE) OINTMENT [WINCO FOODS, LLC]1
BACITRACINACTIVE MOIETY58H6RWO52IWINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE) OINTMENT [WINCO FOODS, LLC]1
NEOMYCINACTIVE MOIETYI16QD7X297WINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE) OINTMENT [WINCO FOODS, LLC]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KWINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE) OINTMENT [WINCO FOODS, LLC]1
PRAMOXINEACTIVE MOIETY068X84E056WINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE) OINTMENT [WINCO FOODS, LLC]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEWINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE) OINTMENT [WINCO FOODS, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UWINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE) OINTMENT [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-272WINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE) OINTMENT [WINCO FOODS, LLC]7Current NDC, Legacy NDC, 2 package rows20241122_01b03c7e-6c4e-43aa-8480-aff1c2688f7f.zip

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 OintmentPSN01b03c7e-6c4e-43aa-8480-aff1c2688f7f7
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD01b03c7e-6c4e-43aa-8480-aff1c2688f7f7
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY01b03c7e-6c4e-43aa-8480-aff1c2688f7f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-272-28670910272281 TUBE in 1 CARTON (67091-272-28) / 28 g in 1 TUBE1 tube2015-02-100000-00-00NoNoCurrent