FDA.reportPublic FDA data

Family Care Triple Antibiotic Original Formula 0.33oz

Product NDC
65923-577
11-digit product format
659230577
Labeler code
65923
Product ID
65923-577_4f1ef127-a67f-ca60-e063-6394a90a3a3d
Type
HUMAN OTC DRUG
Nonproprietary name
Triple Antibiotic Original Formula
Dosage form
OINTMENT
Route
TOPICAL
Labeler
United Exchange Corp
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-10
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [iU]/g; mg/g; [iU]/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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Family Care Triple Antibiotic Original Formula 0.33oz
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [iU]/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
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
65923-577-33Family Care Triple Antibiotic Original Formula 0.33oz1 in 1 BOXOINTMENT11
65923-577-33Family Care Triple Antibiotic Original Formula 0.33oz9.35 g in 1 TUBEOINTMENT9.351

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 OintmentPSN4f1ef127-a67e-ca60-e063-6394a90a3a3d1
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD4f1ef127-a67e-ca60-e063-6394a90a3a3d1
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY4f1ef127-a67e-ca60-e063-6394a90a3a3d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65923-577-33659230577331 TUBE in 1 BOX (65923-577-33) / 9.35 g in 1 TUBE1 tube2026-04-10NoNoCurrent