Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC: 61314-631
11-digit product format: 613140631
Labeler code: 61314
Product ID: 61314-631_247c1988-9ae8-4e3c-80a0-7d88545fe6b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Neomycin and Polymyxin B Sulfates and Dexamethasone
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: NDA050065
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1996-02-21
Substance: DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 1; 3.5; 10000 mg/g; mg/g; [iU]/g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
N050065-002	MAXITROL	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / 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
N050065-002	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	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050065-002	MAXITROL	0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / 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	N050065-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050065-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050065-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050065-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050065-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050065-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050065-002	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050065-002	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050065-002	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050065-002	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050065-002	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050065-002	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050065-002	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050065-002	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050065-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050065-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050065-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050065-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050065-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050065-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050065-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050065-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050065-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050065-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050065-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050065-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050065-002	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050065-002	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050065-002	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050065-002	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050065-002	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050065-002	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050065-002	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050065-002	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050065-002	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050065-002	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050065-002	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050065-002	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050065-002	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050065-002	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Neomycin and Polymyxin B Sulfates and Dexamethasone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEOMYCIN SULFATE	1 mg/g
POLYMYXIN B SULFATE	3.5 mg/g
DEXAMETHASONE	10000 [iU]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
057Y626693	Internal UNII lookup
19371312D4	Internal UNII lookup
7S5I7G3JQL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309679	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7f2e3c46-9f39-45e7-99a9-64cc4f6f649d	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61314-631-36	Neomycin and Polymyxin B Sulfates and Dexamethasone	3.5 g in 1 TUBE	OINTMENT	3.5		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-631-36	GM - Gram	61314-631	42339d82-34e2-4fce-8d84-6f54fbe705ae	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 OINTMENT [FALCON PHARMACEUTICALS, LTD.]	1
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]	1
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]	1
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]	1
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]	1
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61314-631	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [SANDOZ INC]	5	Current NDC, Legacy NDC, 1 package rows	20241123_7f2e3c46-9f39-45e7-99a9-64cc4f6f649d.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 · 6 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 AND POLYMYXIN B SULFATES AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	a7e55c43-4345-4710-e053-2995a90aeee7	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Sandoz Inc	7f2e3c46-9f39-45e7-99a9-64cc4f6f649d	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065 ndc (product): 61314-631
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	A-S Medication Solutions	6791e6c3-514d-4b98-8887-ca2b894576b5	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065
MAXITROL	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Sandoz Inc	5776c435-ac60-49b6-8db1-23a3012b9155	2023-12-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065
MAXITROL	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Novartis Pharmaceuticals Corporation	22c6d2db-85af-4a3b-a014-80d901a86717	2023-06-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Proficient Rx LP	aa7b8a3f-06dd-4190-96a5-f86195bd2197	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050065 application number: NDA050065

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	6791e6c3-514d-4b98-8887-ca2b894576b5	6
309679	dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment	PSN	7f2e3c46-9f39-45e7-99a9-64cc4f6f649d	6
309679	dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment	SCD	6791e6c3-514d-4b98-8887-ca2b894576b5	6
309679	dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment	SCD	7f2e3c46-9f39-45e7-99a9-64cc4f6f649d	6
309679	dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic Ointment	SY	6791e6c3-514d-4b98-8887-ca2b894576b5	6
309679	dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic Ointment	SY	7f2e3c46-9f39-45e7-99a9-64cc4f6f649d	6
309679	dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment	PSN	a7e55c43-4345-4710-e053-2995a90aeee7	4
309679	dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment	SCD	a7e55c43-4345-4710-e053-2995a90aeee7	4
309679	dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic Ointment	SY	a7e55c43-4345-4710-e053-2995a90aeee7	4
309679	dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment	PSN	aa7b8a3f-06dd-4190-96a5-f86195bd2197	2
309679	dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment	SCD	aa7b8a3f-06dd-4190-96a5-f86195bd2197	2
309679	dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic Ointment	SY	aa7b8a3f-06dd-4190-96a5-f86195bd2197	2
309679	dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment	PSN	1fc00d4f-df24-1fb8-e063-6294a90aaee2	1
309679	dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment	PSN	947bcaeb-59da-332e-e053-2995a90aab81	1
309679	dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment	SCD	947bcaeb-59da-332e-e053-2995a90aab81	1
309679	dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment	SCD	1fc00d4f-df24-1fb8-e063-6294a90aaee2	1
309679	dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic Ointment	SY	947bcaeb-59da-332e-e053-2995a90aab81	1
309679	dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic Ointment	SY	1fc00d4f-df24-1fb8-e063-6294a90aaee2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61314-631-36	61314063136	3.5 g in 1 TUBE (61314-631-36)	3.5 g	1996-02-21	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	NuCare Pharmaceuticals,Inc.	2024-12-30	HUMAN PRESCRIPTION DRUG LABEL	4
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment	Sandoz Inc	2024-10-31	HUMAN PRESCRIPTION DRUG LABEL	6
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment	RedPharm Drug	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	1
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment	A-S Medication Solutions	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	6
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE	Direct_Rx	2019-10-09	HUMAN PRESCRIPTION DRUG LABEL	1