Neomycin and Polymyxin B Sulfates and Gramicidin

Product NDC: 21695-528
11-digit product format: 216950528
Labeler code: 21695
Product ID: 21695-528_65edc059-0806-4625-b583-0e36f04cf085
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Neomycin sulfate, Polymyxin B Sulfate and Gramicidin
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Rebel Distributors Corp
Application: ANDA064047
Marketing category: ANDA
Marketing start: 1996-01-31
Marketing end: 0000-00-00
Substance: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN
Active strength: 2 mg/mL; mg/mL; mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
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	21695-528		I	Inactivated by FDA		2026-10-05
excluded package	package	21695-528	21695-528-10	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 · 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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`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	21695-528-10	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064047-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1996-01-31	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A064047-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064047-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064047-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064047-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064047-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064047-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064047-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064047-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064047-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064047-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064047-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064047-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064047-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064047-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064047-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064047-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064047-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064047-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064047-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064047-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064047-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064047-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064047-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064047-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064047-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064047-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064047-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064047-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064047-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064047-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064047-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064047-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064047-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064047-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064047-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064047-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064047-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064047-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064047-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064047-001	AT	1	`f41ea6bd6efb…`

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
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
21695-528-10	2019-09-24	C162847	48780-1	934fe258-4719-48b1-e053-8cdaa90a720a	Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-528-10	Neomycin and Polymyxin B Sulfates and Gramicidin	1 in 1 CARTON	SOLUTION/ DROPS	1		1
21695-528-10	Neomycin and Polymyxin B Sulfates and Gramicidin	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-528-10	ML - Milliliter	21695-528	aee17fa7-f37f-4cad-abda-ad28113e6d25	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Gramicidin	ACTIVE INGREDIENT	5IE62321P4	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Neomycin Sulfate	ACTIVE INGREDIENT	057Y626693	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Polymyxin B Sulfate	ACTIVE INGREDIENT	19371312D4	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Gramicidin	ACTIVE MOIETY	5IE62321P4	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Neomycin	ACTIVE MOIETY	I16QD7X297	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Polymyxin B	ACTIVE MOIETY	J2VZ07J96K	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Thimerosal	INACTIVE INGREDIENT	2225PI3MOV	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-528	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20110113_65edc059-0806-4625-b583-0e36f04cf085.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN	A-S Medication Solutions	9691178e-5323-40ce-a8b3-f79e88f02797	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064047 application number: ANDA064047
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN	Bausch & Lomb Incorporated	e6f8d2f6-adff-4ae1-982c-45562f0a8e28	2024-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064047 application number: ANDA064047

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
5IE62321P4	GRAMICIDIN	1405-97-6	GRAMICIDIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310594	gramicidin 0.025 MG / neomycin sulfate 1.75 MG / polymyxin B sulfate 10,000 UNT per ML Ophthalmic Solution	PSN	65edc059-0806-4625-b583-0e36f04cf085	1
310594	gramicidin 0.025 MG/ML / neomycin 1.75 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic Solution	SCD	65edc059-0806-4625-b583-0e36f04cf085	1
310594	gramicidin 0.025 MG / neomycin (as neomycin sulfate) 1.75 MG / polymyxin B (as polymyxin B sulfate) 10,000 UNT per ML Ophthalmic Solution	SY	65edc059-0806-4625-b583-0e36f04cf085	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-528-10	21695052810	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP	Rebel Distributors Corp	2011-01-03	HUMAN PRESCRIPTION DRUG LABEL	1