CASPORYN HC

Product NDC: 70199-011
11-digit product format: 701990011
Labeler code: 70199
Product ID: 70199-011_26e37e84-0edd-410d-be1a-2bf71d2fe133
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: neomycin and polymyxin B sulfates and hydrocortisone otic
Dosage form: SUSPENSION
Route: AURICULAR (OTIC)
Labeler: Casper Pharma LLC
Application: NDA060613
Marketing category: NDA
Marketing start: 2019-03-15
Marketing end: 0000-00-00
Substance: HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 10 mg/mL; mg/mL; [USP'U]/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: 2023-12-31
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	70199-011		D	Discontinued by firm		2026-09-14
excluded package	package	70199-011	70199-011-10	D	Discontinued by firm		2026-09-14

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70199-011-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70199-011-10	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
N060613-001	CASPORYN HC	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, 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
N060613-001	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 · 43 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
2026-09-14 22:38:34	2026-08	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N060613-001	CASPORYN HC	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N060613-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N060613-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N060613-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N060613-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N060613-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N060613-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N060613-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N060613-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N060613-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N060613-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N060613-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N060613-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N060613-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N060613-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N060613-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N060613-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N060613-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N060613-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N060613-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N060613-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N060613-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N060613-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N060613-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N060613-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N060613-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N060613-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N060613-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N060613-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N060613-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N060613-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N060613-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N060613-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N060613-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N060613-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N060613-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N060613-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N060613-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N060613-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N060613-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N060613-001	AT	1	`f41ea6bd6efb…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70199-011	CASPORYN HC (NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC) SUSPENSION [CASPER PHARMA LLC]	6	Legacy NDC	20240606_14bb3363-1b52-4596-afcc-47457b064217.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 · 3 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 Otic Suspension	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC	Preferred Pharmaceuticals, Inc.	5f17fae0-c6ea-452e-b84f-066caf2a95fc	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 060613 application number: NDA060613
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC	Rising Pharma Holdings, Inc.	35768adc-b578-4c2e-b461-22de3135a789	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 060613 application number: NDA060613
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC	A-S Medication Solutions	c895676f-446a-4a93-a3d2-addcce96b108	2023-01-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 060613 application number: NDA060613

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70199-011-10	70199001110	1 BOTTLE in 1 CARTON (70199-011-10) > 10 mL in 1 BOTTLE	1 bottle	2019-03-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CASPORYN HC (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Sterile	Casper Pharma LLC \| Eugia Pharma Specialities Limited	2024-06-03	Human Prescription Drug Label	6