Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC: 68788-9373
11-digit product format: 687889373
Labeler code: 68788
Product ID: 68788-9373_47fe6ec2-67f9-4b79-8508-f1c175a77bc9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Neomycin, Polymyxin B Sulfates, Dexamethasone
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA062938
Marketing category: ANDA
Marketing start: 2014-09-02
Marketing end: 0000-00-00
Substance: DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 1 mg/g; mg/g; [USP'U]/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68788-9373		D	Discontinued by firm		2026-10-05
excluded package	package	68788-9373	68788-9373-3	D	Discontinued by firm		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 · 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	68788-9373-3	`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	68788-9373-3	`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	68788-9373-3	`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	68788-9373-3	`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	68788-9373-3	`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	68788-9373-3	`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	68788-9373-3	`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	68788-9373-3	`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	68788-9373-3	`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	68788-9373-3	`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	68788-9373-3	`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	68788-9373-3	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC			1989-07-31

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1989-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1989-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062938-001	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1989-07-31	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062938-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062938-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062938-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062938-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062938-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062938-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062938-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062938-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062938-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062938-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062938-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062938-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062938-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062938-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062938-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062938-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062938-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062938-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062938-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062938-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062938-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062938-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062938-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062938-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062938-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062938-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062938-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062938-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062938-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062938-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062938-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062938-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062938-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062938-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062938-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062938-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062938-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062938-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062938-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062938-001	AT	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	1
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	1
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	1
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	1
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	1
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	1

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 Dexamethasone	NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE	Proficient Rx LP	bd9f3220-6d42-4863-aa2a-b17b138d095d	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062938 application number: ANDA062938

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-9373-3	68788937303	1 TUBE in 1 CARTON (68788-9373-3) > 3.5 g in 1 TUBE	1 tube	2014-09-02	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 Ointment USP STERILE Rx Only	Preferred Pharmaceuticals, Inc.	2021-08-12	HUMAN PRESCRIPTION DRUG LABEL	6