Cortisporin TC

Product NDC: 63481-529
Requested package NDC: 63481-529-10
11-digit product format: 634810529
Labeler code: 63481
Product ID: 63481-529_ec1e8a16-a5be-4ff7-a8fe-e0cbfd25aea6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate
Dosage form: SUSPENSION
Route: AURICULAR (OTIC)
Labeler: Endo USA, Inc.
Application: NDA050356
Marketing category: NDA
Marketing start: 2019-06-03
Substance: COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE
Active strength: 3; 10; 3.3; .5 mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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
N050356-001	COLY-MYCIN S	COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC		RLD, RS, Approved before 1982

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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050356-001	COLY-MYCIN S	EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML	SUSPENSION/DROPS / OTIC	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cortisporin TC
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
COLISTIN SULFATE	3 mg/mL
NEOMYCIN SULFATE	10 mg/mL
THONZONIUM BROMIDE	3.3 mg/mL
HYDROCORTISONE ACETATE	.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WP15DXU577	Internal UNII lookup
057Y626693	Internal UNII lookup
JI2B19CR0R	Internal UNII lookup
3X7931PO74	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854992	Internal RxNorm lookup
854997	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
9c6fc1c7-3350-42ae-b999-aca48e704bb1	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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
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
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
f304a07f-cb4d-4a13-bc6d-a0095b865f96	Product name	1	20150611
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	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
63481-529-10	Cortisporin TC	10 mL in 1 BOTTLE, DROPPER	SUSPENSION	10		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63481-529-10	ML - Milliliter	63481-529	f8f9dbc7-6b1d-4a70-9a52-8f82152816be	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63481-529	CORTISPORIN TC (COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE AND HYDROCORTISONE ACETATE) SUSPENSION [ENDO USA, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240913_9c6fc1c7-3350-42ae-b999-aca48e704bb1.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
Cortisporin TC	COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE AND HYDROCORTISONE ACETATE	Endo USA, Inc.	9c6fc1c7-3350-42ae-b999-aca48e704bb1	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050356 application number: NDA050356 ndc (package): 63481-529-10 ndc (product): 63481-529 ndc11 (package): 63481052910

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WP15DXU577	COLISTIN SULFATE	1264-72-8	COLISTIN SULFATE
3X7931PO74	HYDROCORTISONE ACETATE	50-03-3	HYDROCORTISONE ACETATE
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
JI2B19CR0R	THONZONIUM BROMIDE	553-08-2	THONZONIUM BROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854992	colistin sulfate 3 MG / neomycin sulfate 3.3 MG / thonzonium bromide 0.5 MG / hydrocortisone acetate 10 MG in 1 ML Otic Suspension	PSN	9c6fc1c7-3350-42ae-b999-aca48e704bb1	6
854997	Cortisporin-TC 3 MG / 3.3 MG / 0.5 MG / 10 MG in 1 ML Otic Suspension	PSN	9c6fc1c7-3350-42ae-b999-aca48e704bb1	6
854997	colistin 3 MG/ML / hydrocortisone 10 MG/ML / neomycin 3.3 MG/ML / thonzonium bromide 0.5 MG/ML Otic Suspension [Cortisporin-TC]	SBD	9c6fc1c7-3350-42ae-b999-aca48e704bb1	6
854992	colistin 3 MG/ML / hydrocortisone 10 MG/ML / neomycin 3.3 MG/ML / thonzonium bromide 0.5 MG/ML Otic Suspension	SCD	9c6fc1c7-3350-42ae-b999-aca48e704bb1	6
854992	colistin 0.3 % / hydrocortisone 1 % / neomycin 0.33 % / thonzonium bromide 0.05 % Otic Suspension	SY	9c6fc1c7-3350-42ae-b999-aca48e704bb1	6
854997	Cortisporin-TC (colistin 0.3 % / hydrocortisone 1 % / neomycin 0.33 % / thonzonium bromide 0.05 % ) Otic Suspension	SY	9c6fc1c7-3350-42ae-b999-aca48e704bb1	6
854997	Cortisporin-TC (colistin sulfate 3 MG / neomycin sulfate 3.3 MG / thonzonium bromide 0.5 MG / hydrocortisone acetate 10 MG ) per ML Otic Suspension	SY	9c6fc1c7-3350-42ae-b999-aca48e704bb1	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63481-529-10	63481052910	10 mL in 1 BOTTLE, DROPPER (63481-529-10)	10 ml	2019-06-03	0000-00-00	No	No	Current