NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

Product NDC: 61919-113
11-digit product format: 619190113
Labeler code: 61919
Product ID: 61919-113_9caae587-4ea6-7032-e053-2995a90ac302
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: neomycin, polymyxin b sulfates, dexamethasone
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: DIRECT RX
Application: ANDA062938
Marketing category: ANDA
Marketing start: 2017-03-17
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: 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	61919-113		I	Inactivated by FDA		2026-09-09
excluded package	package	61919-113	61919-113-35	I	Inactivated by FDA		2026-09-09

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-113-35	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-113-35	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-113-35	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-113-35	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-113-35	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-113-35	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-113-35	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-113-35	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-113-35	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-113-35	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-113-35	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-113-35	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-113-35	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-113-35	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-113-35	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-113-35	E	Excluded after deficient or non-compliant submission was not corrected	`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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	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	`e64feba35796…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ea46721-9071-6b81-fd0a-a82bfbb014ec	Product name	7	20250220
525701df-f985-480d-995a-e0ee70c2bdf4	Product name	5	20250128
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8	Product name	2	20220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761	Product name	5	20220210
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
399647c0-db89-02d1-991c-0c17b584482c	Product name	1	20140508
3e9a6377-704f-dff7-b19f-56c98d40c444	Product name	1	20140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-113-35	2023-01-30	C162847	48780-1	f386c64a-1cda-0266-e053-dadaa90a7c1a	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-113-35	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	3.5 g in 1 CARTON	OINTMENT	3.5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-113	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [DIRECT RX]	2	Legacy NDC, 1 package rows	20200122_4aecebf1-2f64-725d-e054-00144ff8d46c.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309679	dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment	PSN	4aecebf1-2f64-725d-e054-00144ff8d46c	2
309679	dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment	SCD	4aecebf1-2f64-725d-e054-00144ff8d46c	2
309679	dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic Ointment	SY	4aecebf1-2f64-725d-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-113-35	61919011335	3.5 g in 1 CARTON (61919-113-35)	3.5 g	2017-03-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	2