FDA.reportPublic FDA data

triple antibiotic

Product NDC
41250-067
11-digit product format
412500067
Labeler code
41250
Product ID
41250-067_f9920f43-f0a7-44df-98c0-0738be3f3eda
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin, polymyxin B
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Meijer Distribution Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-04-02
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/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

Additional Listing Data#

Finished product
Yes
Brand name base
triple antibiotic
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4
Rxcui204602

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-067-16triple antibiotic1 in 1 CARTONOINTMENT13
41250-067-16triple antibiotic56 g in 1 TUBEOINTMENT563
41250-067-58triple antibiotic14 g in 1 TUBEOINTMENT143
41250-067-58triple antibiotic1 in 1 CARTONOINTMENT13
41250-067-64triple antibiotic1 in 1 CARTONOINTMENT13
41250-067-64triple antibiotic28 g in 1 TUBEOINTMENT283

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [MEIJER DISTRIBUTION INC]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [MEIJER DISTRIBUTION INC]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [MEIJER DISTRIBUTION INC]1
BACITRACINACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [MEIJER DISTRIBUTION INC]1
NEOMYCINACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [MEIJER DISTRIBUTION INC]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [MEIJER DISTRIBUTION INC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [MEIJER DISTRIBUTION INC]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [MEIJER DISTRIBUTION INC]1
COTTONSEED OILINACTIVE INGREDIENTH3E878020NTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [MEIJER DISTRIBUTION INC]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1ETRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [MEIJER DISTRIBUTION INC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [MEIJER DISTRIBUTION INC]1
SODIUM PYRUVATEINACTIVE INGREDIENTPOD38AIF08TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [MEIJER DISTRIBUTION INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-067TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [MEIJER DISTRIBUTION INC]3Current NDC, Legacy NDC, 6 package rows20240912_edcb423e-b5c2-4e26-8f7f-9b9ee575042c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNedcb423e-b5c2-4e26-8f7f-9b9ee575042c3
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDedcb423e-b5c2-4e26-8f7f-9b9ee575042c3
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYedcb423e-b5c2-4e26-8f7f-9b9ee575042c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-067-16412500067161 TUBE in 1 CARTON (41250-067-16) / 56 g in 1 TUBE1 tube2015-04-020000-00-00NoNoCurrent
41250-067-58412500067581 TUBE in 1 CARTON (41250-067-58) / 14 g in 1 TUBE1 tube2015-05-060000-00-00NoNoCurrent
41250-067-64412500067641 TUBE in 1 CARTON (41250-067-64) / 28 g in 1 TUBE1 tube2015-05-060000-00-00NoNoCurrent