FDA.reportPublic FDA data

berkley and jensen triple antibiotic

Product NDC
68391-207
11-digit product format
683910207
Labeler code
68391
Product ID
68391-207_8408e983-c26a-4fd2-aabb-7d5caa68587b
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin, polymyxin B
Dosage form
OINTMENT
Route
TOPICAL
Labeler
BJWC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-30
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
berkley and jensen 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
68391-207-16berkley and jensen triple antibiotic2 in 1 CARTONOINTMENT24
68391-207-64berkley and jensen triple antibiotic28 g in 1 TUBEOINTMENT284

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESBERKLEY AND JENSEN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [BJWC]2
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693BERKLEY AND JENSEN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [BJWC]2
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4BERKLEY AND JENSEN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [BJWC]2
BACITRACINACTIVE MOIETY58H6RWO52IBERKLEY AND JENSEN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [BJWC]2
NEOMYCINACTIVE MOIETYI16QD7X297BERKLEY AND JENSEN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [BJWC]2
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KBERKLEY AND JENSEN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [BJWC]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BERKLEY AND JENSEN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [BJWC]2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRBERKLEY AND JENSEN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [BJWC]2
COTTONSEED OILINACTIVE INGREDIENTH3E878020NBERKLEY AND JENSEN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [BJWC]2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EBERKLEY AND JENSEN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [BJWC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBERKLEY AND JENSEN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [BJWC]2
SODIUM PYRUVATEINACTIVE INGREDIENTPOD38AIF08BERKLEY AND JENSEN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [BJWC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-207BERKLEY AND JENSEN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [BJWC]4Current NDC, Legacy NDC, 2 package rows20241013_e81d32cb-4512-4b25-8d63-e3335e8e8ecf.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 OintmentPSNe81d32cb-4512-4b25-8d63-e3335e8e8ecf4
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDe81d32cb-4512-4b25-8d63-e3335e8e8ecf4
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYe81d32cb-4512-4b25-8d63-e3335e8e8ecf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-207-16683910207162 TUBE in 1 CARTON (68391-207-16) / 28 g in 1 TUBE (68391-207-64) 2 tube2014-10-300000-00-00NoNoCurrent
68391-207-646839102076428 g in 1 TUBE28 gHistorical