Family Care Triple Antibiotic

Product NDC
65923-046
11-digit product format
659230046
Labeler code
65923
Product ID
65923-046_de20833b-e6f5-35f9-e053-2995a90a46cd
Type
HUMAN OTC DRUG
Nonproprietary name
Neomycin, Bacitracin, Polymyxin B
Dosage form
OINTMENT
Route
TOPICAL
Labeler
United Exchange Corp.
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-19
Marketing end
0000-00-00
Substance
BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400 [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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65923-046DDiscontinued by firm2026-10-12
excluded packagepackage65923-04665923-046-33DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65923-046-33d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65923-046-33f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65923-046-332ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65923-046-33a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65923-046-33cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65923-046-33cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65923-046-33302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65923-046-33ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65923-046-330efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52IFAMILY CARE TRIPLE ANTIBIOTIC (NEOMYCIN, BACITRACIN, POLYMYXIN B) OINTMENT [UNITED EXCHANGE CORP.]2
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693FAMILY CARE TRIPLE ANTIBIOTIC (NEOMYCIN, BACITRACIN, POLYMYXIN B) OINTMENT [UNITED EXCHANGE CORP.]2
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4FAMILY CARE TRIPLE ANTIBIOTIC (NEOMYCIN, BACITRACIN, POLYMYXIN B) OINTMENT [UNITED EXCHANGE CORP.]2
BACITRACINACTIVE MOIETY58H6RWO52IFAMILY CARE TRIPLE ANTIBIOTIC (NEOMYCIN, BACITRACIN, POLYMYXIN B) OINTMENT [UNITED EXCHANGE CORP.]2
NEOMYCINACTIVE MOIETYI16QD7X297FAMILY CARE TRIPLE ANTIBIOTIC (NEOMYCIN, BACITRACIN, POLYMYXIN B) OINTMENT [UNITED EXCHANGE CORP.]2
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KFAMILY CARE TRIPLE ANTIBIOTIC (NEOMYCIN, BACITRACIN, POLYMYXIN B) OINTMENT [UNITED EXCHANGE CORP.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFAMILY CARE TRIPLE ANTIBIOTIC (NEOMYCIN, BACITRACIN, POLYMYXIN B) OINTMENT [UNITED EXCHANGE CORP.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFAMILY CARE TRIPLE ANTIBIOTIC (NEOMYCIN, BACITRACIN, POLYMYXIN B) OINTMENT [UNITED EXCHANGE CORP.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UFAMILY CARE TRIPLE ANTIBIOTIC (NEOMYCIN, BACITRACIN, POLYMYXIN B) OINTMENT [UNITED EXCHANGE CORP.]2
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IFAMILY CARE TRIPLE ANTIBIOTIC (NEOMYCIN, BACITRACIN, POLYMYXIN B) OINTMENT [UNITED EXCHANGE CORP.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFAMILY CARE TRIPLE ANTIBIOTIC (NEOMYCIN, BACITRACIN, POLYMYXIN B) OINTMENT [UNITED EXCHANGE CORP.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65923-046-33659230046331 TUBE in 1 CARTON (65923-046-33) > 9.35 g in 1 TUBE1 tube2016-09-150000-00-00NoNoCurrent