FDA.reportPublic FDA data

TRIPLE ANTIBIOTIC

Product NDC
82695-0001
Requested package NDC
82695-0001-4
11-digit product format
826950001
Labeler code
82695
Product ID
82695-0001_ebd61edc-4a1d-2a36-e053-2a95a90af97f
Type
HUMAN OTC DRUG
Nonproprietary name
POLYMYXIN B SULFATE, NEOMYCIN SULFATE, BACITRACIN, LIDOCAINE HYDROCHLORIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Shandong Teking Pharmaceutical Co., Ltd
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-05-23
Marketing end
0000-00-00
Substance
BACITRACIN; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
500 [USP'U]/g; mg/g; [USP'U]/g; [USP'U]/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antiarrhythmic [EPC], Decreased Cell Wall Synthesis & Repair [PE], Local Anesthesia [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 packagepackage82695-000182695-0001-4IInactivated 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82695-0001-32024-01-30C16284748780-11030e365-373e-111a-e063-dadaa90a10e2dfa4ac4e-8ebd-fa0a-e053-2a95a90a4f63
82695-0001-42024-01-30C16284748780-11030e365-18eb-111a-e063-dadaa90a10e2dfa5710f-9d4c-29b0-e053-2995a90aa5e5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82695-0001-3TRIPLE ANTIBIOTIC28.3 g in 1 TUBEOINTMENT28.34
82695-0001-4TRIPLE ANTIBIOTIC14.2 g in 1 TUBEOINTMENT14.24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82695-0001TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, NEOMYCIN SULFATE, BACITRACIN, LIDOCAINE HYDROCHLORIDE) OINTMENT [SHANDONG TEKING PHARMACEUTICAL CO., LTD]4Legacy NDC, 1 package rows20221027_dfa4ac4e-8ebd-fa0a-e053-2a95a90a4f63.zip
82695-0001TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, NEOMYCIN SULFATE, BACITRACIN, LIDOCAINE HYDROCHLORIDE) OINTMENT [SHANDONG TEKING PHARMACEUTICAL CO., LTD]4Legacy NDC, 1 package rows20221027_dfa5710f-9d4c-29b0-e053-2995a90aa5e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2281302bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical OintmentPSNdfa4ac4e-8ebd-fa0a-e053-2a95a90a4f634
2281302bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical OintmentPSNdfa5710f-9d4c-29b0-e053-2995a90aa5e54
2281302bacitracin 0.5 UNT/MG / lidocaine hydrochloride 0.04 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDdfa4ac4e-8ebd-fa0a-e053-2a95a90a4f634
2281302bacitracin 0.5 UNT/MG / lidocaine hydrochloride 0.04 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDdfa5710f-9d4c-29b0-e053-2995a90aa5e54
2281302bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical OintmentSYdfa4ac4e-8ebd-fa0a-e053-2a95a90a4f634
2281302bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical OintmentSYdfa5710f-9d4c-29b0-e053-2995a90aa5e54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82695-0001-48269500010414.2 g in 1 TUBE (82695-0001-4) 14.2 g2022-05-230000-00-00NoNoCurrent