Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC: 49999-141
11-digit product format: 499990141
Labeler code: 49999
Product ID: 49999-141_05ab45d2-cd19-4d80-88d6-d40133be4039
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: neomycin sulfate, polymyxin b sulfate and dexamethasone
Dosage form: SUSPENSION
Route: OPHTHALMIC
Labeler: Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Application: ANDA062341
Marketing category: ANDA
Marketing start: 1996-02-21
Marketing end: 0000-00-00
Substance: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
Active strength: 4 mg/mL; [USP'U]/mL; mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	49999-141		D	Discontinued by firm		2026-08-17
excluded package	package	49999-141	49999-141-05	D	Discontinued by firm		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 · 24 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	49999-141-05	`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	49999-141-05	`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	49999-141-05	`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	49999-141-05	`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	49999-141-05	`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	49999-141-05	`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	49999-141-05	`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	49999-141-05	`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	49999-141-05	`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	49999-141-05	`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	49999-141-05	`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	49999-141-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A062341-001	MAXITROL	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT		1984-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062341-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`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	A062341-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062341-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062341-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062341-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062341-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062341-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062341-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062341-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062341-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062341-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062341-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062341-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062341-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062341-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062341-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062341-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062341-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062341-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062341-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062341-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062341-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062341-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062341-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062341-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062341-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062341-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062341-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062341-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062341-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062341-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062341-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062341-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062341-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062341-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062341-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062341-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062341-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062341-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062341-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062341-001	AT	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49999-141-05	ML - Milliliter	49999-141	b3d78936-c21e-4cd6-9055-a745ea29d45e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXAMETHASONE	ACTIVE INGREDIENT	7S5I7G3JQL	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3864
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3864
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3864
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3864
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3864
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3864
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3864
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3864
HYPROMELLOSE 2910 (4000 MPA.S)	INACTIVE INGREDIENT	RN3152OP35	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3864
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3864
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3864
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3864
WATER	INACTIVE INGREDIENT	059QF0KO0R	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3864

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 Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Sandoz Inc.	cf1a6da8-ba79-4bff-a13b-6effb67f6c1c	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062341 application number: ANDA062341
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	54da7bef-c3b0-4353-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062341 application number: ANDA062341

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
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49999-141-05	49999014105	5 mL in 1 BOTTLE, PLASTIC (49999-141-05)	5 ml	2010-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension Sterile	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	2020-09-21	HUMAN PRESCRIPTION DRUG LABEL	3869