Maxitrol

Product NDC: 0998-0630
Requested package NDC: 0998-0630-06
11-digit product format: 009980630
Labeler code: 0998
Product ID: 0998-0630_03cfa73d-29e8-499c-9ac2-79bcbaa222e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: neomycin sulfate, polymyxin b sulfate and dexamethasone
Dosage form: SUSPENSION
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: NDA050023
Marketing category: NDA
Marketing start: 1964-11-15
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0998-0630	0998-0630-06	D	Discontinued by firm		2026-08-11

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 · 14 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N050023-002	MAXITROL	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050023-002	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050023-002	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050023-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050023-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050023-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050023-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050023-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050023-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050023-002	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050023-002	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050023-002	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050023-002	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050023-002	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050023-002	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050023-002	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050023-002	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050023-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050023-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050023-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050023-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050023-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050023-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050023-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050023-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050023-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050023-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050023-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050023-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050023-002	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050023-002	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050023-002	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050023-002	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050023-002	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050023-002	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050023-002	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050023-002	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050023-002	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050023-002	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050023-002	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050023-002	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050023-002	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050023-002	AT	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0998-0630-06	2024-05-02	C162847	48780-1	e4f33bdf-a11b-d8a0-e053-dadaa90a6e4e	277ff310-b7dc-43b6-8a16-885b58882bc0
0998-0630-06	2022-07-29	C162847	48780-1	e4f33bdf-a11b-d8a0-e053-dadaa90a6e4e	277ff310-b7dc-43b6-8a16-885b58882bc0

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0998-0630-06	ML - Milliliter	0998-0630	c6c36128-f66e-43db-85f4-e5ec0bd415c8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXAMETHASONE	ACTIVE INGREDIENT	7S5I7G3JQL	MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	3
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	3
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	3
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	3
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	3
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	3
HYPROMELLOSE 2910 (4000 MPA.S)	INACTIVE INGREDIENT	RN3152OP35	MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	3
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	MAXITROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.]	3

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
Maxitrol	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Harrow Eye, LLC	ecfb954f-5554-0ad2-e053-2995a90a7516	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050023 application number: NDA050023
neomycin sulfate, polymyxin b sulfate and dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Nordic Pharma, Inc.	191c1a56-194f-4876-b501-2f8aee447d83	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050023 application number: NDA050023

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
0998-0630-06	00998063006	5 mL in 1 BOTTLE, PLASTIC (0998-0630-06)	5 ml	1964-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Maxitrol - Alcon Laboratories, Inc.	Alcon Laboratories, Inc.	2021-05-14	HUMAN PRESCRIPTION DRUG LABEL	10