Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product NDC: 53002-9061
11-digit product format: 530029061
Labeler code: 53002
Product ID: 53002-9061_f800c7e8-a7f5-4be3-ad8b-3a5d2fa35e99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
Dosage form: SOLUTION/ DROPS
Route: AURICULAR (OTIC)
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA064053
Marketing category: ANDA
Marketing start: 1995-12-29
Marketing end: 0000-00-00
Substance: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
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	53002-9061		I	Inactivated by FDA		2026-08-17
excluded package	package	53002-9061	53002-9061-1	I	Inactivated by FDA		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 · 22 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	53002-9061-1	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	53002-9061-1	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	53002-9061-1	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	53002-9061-1	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	53002-9061-1	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	53002-9061-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-9061-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-9061-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-9061-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-9061-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-9061-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064053-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064053-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SOLUTION/DROPS / OTIC	AT	RS	1995-12-29	`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	A064053-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064053-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064053-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064053-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064053-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064053-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064053-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064053-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064053-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064053-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064053-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064053-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064053-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064053-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064053-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064053-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064053-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064053-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064053-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064053-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064053-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064053-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064053-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064053-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064053-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064053-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064053-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064053-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064053-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064053-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064053-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064053-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064053-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064053-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064053-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064053-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064053-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064053-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064053-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064053-001	AT	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-30	Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution, USP (Sterile)
2023-06-07	Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution, USP (Sterile)
2023-01-30	Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution, USP (Sterile)
2020-12-17	Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution, USP (Sterile)
2020-01-31	Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution, USP (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-9061-1	Neomycin and Polymyxin B Sulfates and Hydrocortisone	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10		5
53002-9061-1	Neomycin and Polymyxin B Sulfates and Hydrocortisone	1 in 1 CARTON	SOLUTION/ DROPS	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-9061	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE) SOLUTION/ DROPS [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 2 package rows	20230609_7f616d43-d737-4391-9faa-3f13d3bc96e9.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	Sportpharm LLC	9117d5f7-9020-4e76-9bd0-a690b6dfebd3	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064053 application number: ANDA064053
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	A-S Medication Solutions	498f34db-89e8-49cc-8543-87da3f4344ec	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064053 application number: ANDA064053
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	REMEDYREPACK INC.	04fe1b32-adfb-4c36-a986-d81b49497e0f	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064053 application number: ANDA064053
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	Bausch & Lomb Incoporated	986e5b75-39fc-480f-9026-191b2d15dea1	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064053 application number: ANDA064053
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	5f9c25b1-67d0-11ae-e053-2a91aa0ad8f4	2024-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064053 application number: ANDA064053
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	Proficient Rx LP	d55f1783-9c49-4f90-9ff8-6f132e7b325e	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064053 application number: ANDA064053
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE	Asclemed USA, Inc.	7c78ec84-8b7c-42f1-a879-3bf27a1daa71	2020-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064053 application number: ANDA064053

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
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
204423	neomycin sulfate 0.35 % / polymyxin B sulfate 10,000 UNT/ML / hydrocortisone 1 % Otic Solution	PSN	7f616d43-d737-4391-9faa-3f13d3bc96e9	5
204423	hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic Solution	SCD	7f616d43-d737-4391-9faa-3f13d3bc96e9	5
204423	hydrocortisone 1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML Otic Solution	SY	7f616d43-d737-4391-9faa-3f13d3bc96e9	5
204423	hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per ML Otic Solution	SY	7f616d43-d737-4391-9faa-3f13d3bc96e9	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-9061-1	53002906101	1 BOTTLE, DROPPER in 1 CARTON (53002-9061-1) > 10 mL in 1 BOTTLE, DROPPER	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution, USP (Sterile)	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5