Triple Antibiotic

Product NDC: 57319-343
11-digit product format: 573190343
Labeler code: 57319
Product ID: 57319-343_f7504b22-2d9e-4e2c-a308-1469bd5a1bab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Phoenix Pharmaceutical, Inc.
Application: ANDA064064
Marketing category: ANDA
Marketing start: 1995-10-30
Marketing end: 0000-00-00
Substance: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC
Active strength: 4 mg/g; [USP'U]/g; [USP'U]/g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	57319-343		I	Inactivated by FDA		2026-08-17
excluded package	package	57319-343	57319-343-25	I	Inactivated by FDA		2026-08-17

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 · 44 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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`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	57319-343-25	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	57319-343-25	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	57319-343-25	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A064064-001	AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A064064-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064064-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064064-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064064-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064064-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064064-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064064-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064064-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064064-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064064-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064064-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064064-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064064-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064064-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064064-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064064-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064064-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064064-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064064-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064064-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064064-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064064-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064064-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064064-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064064-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064064-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064064-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064064-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064064-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064064-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064064-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064064-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064064-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064064-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064064-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064064-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064064-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064064-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064064-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064064-001	AT	1	`e64feba35796…`

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
57319-343-25	2019-10-29	C162847	48780-1	960f7f55-c5ab-8e05-e053-dbdaa90a074a	Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57319-343-25	Triple Antibiotic	1 in 1 CARTON	OINTMENT	1		1
57319-343-25	Triple Antibiotic	3.5 g in 1 TUBE	OINTMENT	3.5		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACITRACIN ZINC	ACTIVE INGREDIENT	89Y4M234ES	TRIPLE ANTIBIOTIC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]	1
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	TRIPLE ANTIBIOTIC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]	1
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	TRIPLE ANTIBIOTIC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]	1
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	TRIPLE ANTIBIOTIC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]	1
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	TRIPLE ANTIBIOTIC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]	1
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	TRIPLE ANTIBIOTIC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	TRIPLE ANTIBIOTIC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	TRIPLE ANTIBIOTIC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57319-343	TRIPLE ANTIBIOTIC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]	1	Legacy NDC, 2 package rows	20101122_f7504b22-2d9e-4e2c-a308-1469bd5a1bab.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC	Bausch & Lomb Incorporated	f3231f1c-665e-4efa-baa1-83bf296b2f8f	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064064 application number: ANDA064064

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308493	bacitracin zinc 400 UNT / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment	PSN	f7504b22-2d9e-4e2c-a308-1469bd5a1bab	1
308493	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment	SCD	f7504b22-2d9e-4e2c-a308-1469bd5a1bab	1
308493	bacitracin 0.4 UNT/MG / neomycin 0.35 % / polymyxin B 10 UNT/MG Ophthalmic Ointment	SY	f7504b22-2d9e-4e2c-a308-1469bd5a1bab	1
308493	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Ophthalmic Ointment	SY	f7504b22-2d9e-4e2c-a308-1469bd5a1bab	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
57319-343-25	57319034325	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP (Sterile)	Phoenix Pharmaceutical, Inc. \| Bausch & Lomb Incorporated	2010-11-04	HUMAN PRESCRIPTION DRUG LABEL	1