Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product NDC: 61314-641
11-digit product format: 613140641
Labeler code: 61314
Product ID: 61314-641_15cc1b8f-5a7f-4cfb-8c65-9d35f7c0f30f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: neomycin sulfate, polymyxin b sulfate and hydrocortisone
Dosage form: SUSPENSION
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: ANDA062874
Marketing category: ANDA
Marketing start: 2003-05-09
Substance: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
Active strength: 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL
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 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
A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC		RS	1988-05-11

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062874-001	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	RS	1988-05-11	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEOMYCIN SULFATE	3.5 mg/mL
POLYMYXIN B SULFATE	10000 [USP'U]/mL
HYDROCORTISONE	10 mg/mL

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
WI4X0X7BPJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204874	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
96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d	Available on FDA.report

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61314-641-75	Neomycin and Polymyxin B Sulfates and Hydrocortisone	7.5 mL in 1 BOTTLE, PLASTIC	SUSPENSION	7.5		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-641-75	ML - Milliliter	61314-641	078a5019-53ee-457c-a00a-e01ef44f7bb0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
THIMEROSAL	INACTIVE INGREDIENT	2225PI3MOV	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.]	4
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1
THIMEROSAL	INACTIVE INGREDIENT	2225PI3MOV	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1
THIMEROSAL	INACTIVE INGREDIENT	2225PI3MOV	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61314-641	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [SANDOZ INC]	8	Current NDC, Legacy NDC, 1 package rows	20220216_96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d.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 Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Sandoz Inc	96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d	2021-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062874 application number: ANDA062874 ndc (product): 61314-641

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
204874	neomycin sulfate 0.35 % / polymyxin B sulfate 10,000 UNT/ML / hydrocortisone 1 % Ophthalmic Suspension	PSN	96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d	8
204874	hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic Suspension	SCD	96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d	8
204874	hydrocortisone 1 % / neomycin (neomycin sulfate) 0.35 % / polymyxin B (polymyxin B sulfate) 10,000 UNT/ML Ophthalmic Suspension	SY	96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d	8
204874	neomycin sulfate 0.35 % / polymyxin B sulfate 10,000 UNT/ML / hydrocortisone 1 % Ophthalmic Suspension	PSN	64e4cb91-f5bd-4a2f-b92d-0a1341f40d35	1
204874	hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic Suspension	SCD	64e4cb91-f5bd-4a2f-b92d-0a1341f40d35	1
204874	hydrocortisone 1 % / neomycin (neomycin sulfate) 0.35 % / polymyxin B (polymyxin B sulfate) 10,000 UNT/ML Ophthalmic Suspension	SY	64e4cb91-f5bd-4a2f-b92d-0a1341f40d35	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61314-641-75	61314064175	7.5 mL in 1 BOTTLE, PLASTIC (61314-641-75)	7.5 ml	2003-05-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OPHTHALMIC SUSPENSION, USP	Sandoz Inc	2021-08-31	HUMAN PRESCRIPTION DRUG LABEL	8
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE - STAT RX USA LLC	STAT RX USA LLC	2010-06-09	HUMAN PRESCRIPTION DRUG LABEL	1