FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
63868-459
Requested package NDC
63868-459-05
11-digit product format
638680459
Labeler code
63868
Product ID
63868-459_bafd8092-b386-46b8-e053-2995a90ae522
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Chain Drug Marketing Association
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-03-26
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400 [USP'U]/g; mg/g; [USP'U]/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage63868-45963868-459-05IInactivated by FDA2026-10-05

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 · 9 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 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63868-459-052025-01-30Triple Antibiotic Ointment First Aid Antibiotic
63868-459-102025-01-30Triple Antibiotic Ointment First Aid Antibiotic
63868-459-052023-05-25Triple Antibiotic Ointment First Aid Antibiotic
63868-459-102023-05-25Triple Antibiotic Ointment First Aid Antibiotic
63868-459-052023-01-30Triple Antibiotic Ointment First Aid Antibiotic
63868-459-102023-01-30Triple Antibiotic Ointment First Aid Antibiotic
63868-459-052021-02-10Triple Antibiotic Ointment First Aid Antibiotic
63868-459-102021-02-10Triple Antibiotic Ointment First Aid Antibiotic
63868-459-052021-01-29Triple Antibiotic Ointment First Aid Antibiotic
63868-459-102021-01-29Triple Antibiotic Ointment First Aid Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-459-05Triple Antibiotic14.2 g in 1 TUBEOINTMENT14.23
63868-459-05Triple Antibiotic1 in 1 BOXOINTMENT13
63868-459-10Triple Antibiotic1 in 1 BOXOINTMENT13
63868-459-10Triple Antibiotic28.3 g in 1 TUBEOINTMENT28.33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-459-05GM - Gram63868-459e1060249-cf63-49f4-b7b1-08ec64b7c32812022-09-12
63868-459-10GM - Gram63868-45966e2d87b-7764-455d-bdc4-12b94df2363d12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-459TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION]3Legacy NDC, 4 package rows20230526_8501adcd-97e1-bd25-e053-2a91aa0ad747.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 OintmentPSN8501adcd-97e1-bd25-e053-2a91aa0ad7473
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD8501adcd-97e1-bd25-e053-2a91aa0ad7473
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY8501adcd-97e1-bd25-e053-2a91aa0ad7473

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-459-05638680459051 TUBE in 1 BOX (63868-459-05) > 14.2 g in 1 TUBE1 tube2019-03-260000-00-00NoNoCurrent