FDA.reportPublic FDA data

bacitracin zinc, neomycin sulfate and polymyxin b sulfate

Product NDC
68786-216
Requested package NDC
68786-216-02
11-digit product format
687860216
Labeler code
68786
Product ID
68786-216_d4b21ffb-13ea-81fd-e053-2a95a90a774b
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate and polymyxin b sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sion Biotext Medical Ltd
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-07-09
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68786-21668786-216-02DDiscontinued by firm2026-10-16

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68786-216-012022-01-30Triple Antibiotic Ointment
68786-216-022022-01-30Triple Antibiotic Ointment
68786-216-032022-01-30Triple Antibiotic Ointment
68786-216-042022-01-30Triple Antibiotic Ointment
68786-216-052022-01-30Triple Antibiotic Ointment
68786-216-012020-01-31Triple Antibiotic Ointment
68786-216-022020-01-31Triple Antibiotic Ointment
68786-216-032020-01-31Triple Antibiotic Ointment
68786-216-042020-01-31Triple Antibiotic Ointment
68786-216-052020-01-31Triple Antibiotic Ointment

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESBACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [SION BIOTEXT MEDICAL LTD]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [SION BIOTEXT MEDICAL LTD]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [SION BIOTEXT MEDICAL LTD]1
BACITRACIN ZINCACTIVE MOIETY89Y4M234ESBACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [SION BIOTEXT MEDICAL LTD]1
NEOMYCINACTIVE MOIETYI16QD7X297BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [SION BIOTEXT MEDICAL LTD]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KBACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [SION BIOTEXT MEDICAL LTD]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [SION BIOTEXT MEDICAL LTD]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68786-216-02687860216021728 PACKET in 1 CASE (68786-216-02) > .9 g in 1 PACKET1728 packet2012-07-110000-00-00NoNoCurrent