TRIPLE ANTIBIOTIC

Product NDC: 82695-0001
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	82695-0001		I	Inactivated by FDA	2026-10-05
excluded product	product	82695-0001		I	Inactivated by FDA	2026-10-05
excluded package	package	82695-0001	82695-0001-3	I	Inactivated by FDA	2026-10-05
excluded package	package	82695-0001	82695-0001-4	I	Inactivated by FDA	2026-10-05

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82695-0001-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82695-0001-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82695-0001-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82695-0001-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82695-0001-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82695-0001-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82695-0001-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82695-0001-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82695-0001-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82695-0001-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82695-0001-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82695-0001-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82695-0001-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82695-0001-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82695-0001-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82695-0001-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82695-0001-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82695-0001-3	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	82695-0001-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	82695-0001-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	82695-0001-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	82695-0001-3	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	82695-0001-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	82695-0001-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	82695-0001-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	82695-0001-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	82695-0001-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	82695-0001-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	82695-0001-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	82695-0001-3	`1332a3947898…`	`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 concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82695-0001-3	2024-01-30	C162847	48780-1	1030e365-373e-111a-e063-dadaa90a10e2	dfa4ac4e-8ebd-fa0a-e053-2a95a90a4f63
82695-0001-4	2024-01-30	C162847	48780-1	1030e365-18eb-111a-e063-dadaa90a10e2	dfa5710f-9d4c-29b0-e053-2995a90aa5e5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82695-0001-3	TRIPLE ANTIBIOTIC	28.3 g in 1 TUBE	OINTMENT	28.3		4
82695-0001-4	TRIPLE ANTIBIOTIC	14.2 g in 1 TUBE	OINTMENT	14.2		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82695-0001	TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, NEOMYCIN SULFATE, BACITRACIN, LIDOCAINE HYDROCHLORIDE) OINTMENT [SHANDONG TEKING PHARMACEUTICAL CO., LTD]	4	Legacy NDC, 1 package rows	20221027_dfa4ac4e-8ebd-fa0a-e053-2a95a90a4f63.zip
82695-0001	TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, NEOMYCIN SULFATE, BACITRACIN, LIDOCAINE HYDROCHLORIDE) OINTMENT [SHANDONG TEKING PHARMACEUTICAL CO., LTD]	4	Legacy NDC, 1 package rows	20221027_dfa5710f-9d4c-29b0-e053-2995a90aa5e5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
58H6RWO52I	BACITRACIN	1405-87-4	BACITRACIN
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2281302	bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical Ointment	PSN	dfa4ac4e-8ebd-fa0a-e053-2a95a90a4f63	4
2281302	bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical Ointment	PSN	dfa5710f-9d4c-29b0-e053-2995a90aa5e5	4
2281302	bacitracin 0.5 UNT/MG / lidocaine hydrochloride 0.04 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	dfa4ac4e-8ebd-fa0a-e053-2a95a90a4f63	4
2281302	bacitracin 0.5 UNT/MG / lidocaine hydrochloride 0.04 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	dfa5710f-9d4c-29b0-e053-2995a90aa5e5	4
2281302	bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical Ointment	SY	dfa4ac4e-8ebd-fa0a-e053-2a95a90a4f63	4
2281302	bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical Ointment	SY	dfa5710f-9d4c-29b0-e053-2995a90aa5e5	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82695-0001-3	82695000103	28.3 g in 1 TUBE (82695-0001-3)	28.3 g	2022-05-23	0000-00-00	No	No	Current
82695-0001-4	82695000104	14.2 g in 1 TUBE (82695-0001-4)	14.2 g	2022-05-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRIPLE ANTIBIOTIC - Shandong Teking Pharmaceutical Co., Ltd	Shandong Teking Pharmaceutical Co., Ltd	2022-10-25	HUMAN OTC DRUG LABEL	4
TRIPLE ANTIBIOTIC - Shandong Teking Pharmaceutical Co., Ltd	Shandong Teking Pharmaceutical Co., Ltd	2022-10-25	HUMAN OTC DRUG LABEL	4