Repara Triple Antibiotic

Product NDC: 68345-820
11-digit product format: 683450820
Labeler code: 68345
Product ID: 68345-820_9a511d5b-c719-4a2e-81fb-0cc6c55ad8a6
Type: HUMAN OTC DRUG
Nonproprietary name: BACITRACIN, NEOMYCIN and POLYMYXIN B
Dosage form: OINTMENT
Route: TOPICAL
Labeler: PSS WORLD MEDICAL, INC.
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2007-12-01
Marketing end: 0000-00-00
Substance: BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 400 [iU]/g; mg/g; [iU]/g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68345-820		I	Inactivated by FDA	2026-10-12
excluded package	package	68345-820	68345-820-22	I	Inactivated by FDA	2026-10-12
excluded package	package	68345-820	68345-820-26	I	Inactivated by FDA	2026-10-12

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 2 · 66 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 package	package	68345-820-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68345-820-22	`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 package	package	68345-820-26	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68345-820-22	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68345-820-26	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68345-820-22	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68345-820-26	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68345-820-22	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68345-820-26	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68345-820-22	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68345-820-26	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68345-820-22	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68345-820-26	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68345-820-22	`e2bbac7714bc…`	`27bdfed8d636…`

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
68345-820-22	2019-11-27	C162847	48780-1	9855d018-d8cb-cd31-e053-dbdaa90ab51a	REPARA (Triple Antibiotic), ointment
68345-820-26	2019-11-27	C162847	48780-1	9855d018-d8cb-cd31-e053-dbdaa90ab51a	REPARA (Triple Antibiotic), ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68345-820-22	Repara Triple Antibiotic	12 in 1 CASE	OINTMENT	12	2
68345-820-22	Repara Triple Antibiotic	144 in 1 BOX	OINTMENT	144	2
68345-820-26	Repara Triple Antibiotic	12 in 1 BOX	OINTMENT	12	2
68345-820-26	Repara Triple Antibiotic	12 in 1 CASE	OINTMENT	12	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACITRACIN	ACTIVE INGREDIENT	58H6RWO52I	REPARA TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN AND POLYMYXIN B) OINTMENT [PSS WORLD MEDICAL, INC.]	2
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	REPARA TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN AND POLYMYXIN B) OINTMENT [PSS WORLD MEDICAL, INC.]	2
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	REPARA TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN AND POLYMYXIN B) OINTMENT [PSS WORLD MEDICAL, INC.]	2
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	REPARA TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN AND POLYMYXIN B) OINTMENT [PSS WORLD MEDICAL, INC.]	2
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	REPARA TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN AND POLYMYXIN B) OINTMENT [PSS WORLD MEDICAL, INC.]	2
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	REPARA TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN AND POLYMYXIN B) OINTMENT [PSS WORLD MEDICAL, INC.]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	REPARA TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN AND POLYMYXIN B) OINTMENT [PSS WORLD MEDICAL, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68345-820	REPARA TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN AND POLYMYXIN B) OINTMENT [PSS WORLD MEDICAL, INC.]	2	Legacy NDC, 4 package rows	20130620_f169f613-91b3-47f2-aac1-49cd1d7f6d8a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
58H6RWO52I	BACITRACIN	1405-87-4	BACITRACIN
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
204602	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment	PSN	f169f613-91b3-47f2-aac1-49cd1d7f6d8a	2
1427298	REPARA Triple Antibiotic 400 UNT / 3.5 MG / 5000 UNT per GM Topical Ointment	PSN	f169f613-91b3-47f2-aac1-49cd1d7f6d8a	2
1427298	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment [Repara Triple Antibiotic]	SBD	f169f613-91b3-47f2-aac1-49cd1d7f6d8a	2
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	f169f613-91b3-47f2-aac1-49cd1d7f6d8a	2
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	f169f613-91b3-47f2-aac1-49cd1d7f6d8a	2
1427298	Repara Triple Antibiotic (bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT) per GM Topical Ointment	SY	f169f613-91b3-47f2-aac1-49cd1d7f6d8a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68345-820-22	68345082022	12 in 1 CASE	Historical
68345-820-26	68345082026	12 in 1 BOX	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
REPARA (Triple Antibiotic), ointment	PSS WORLD MEDICAL, INC. \| Zhejiang Medicare Pharmaceutical Co., Ltd.	2013-06-19	HUMAN OTC DRUG LABEL	2