hydrocortisone and acetic acid

Product NDC: 71656-064
11-digit product format: 716560064
Labeler code: 71656
Product ID: 71656-064_339e0417-4d1a-e168-e063-6294a90a50bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocortisone and acetic acid otic
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: Saptalis Pharmaceuticals, LLC
Application: NDA012770
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-02-23
Substance: ACETIC ACID; HYDROCORTISONE
Active strength: 20.75; 10.375 mg/mL; mg/mL
Pharmacologic classes: 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 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
N012770-001	VOSOL HC	ACETIC ACID, GLACIAL; HYDROCORTISONE	2%;1%	SOLUTION/DROPS / OTIC	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
N012770-001	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	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012770-001	VOSOL HC	2%;1%	SOLUTION/DROPS / OTIC	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012770-001	VOSOL HC	2%;1%	SOLUTION/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	N012770-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N012770-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012770-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012770-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012770-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012770-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012770-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012770-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012770-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012770-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012770-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012770-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012770-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012770-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012770-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012770-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012770-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012770-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012770-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012770-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012770-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012770-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012770-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012770-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012770-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012770-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012770-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012770-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012770-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012770-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012770-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012770-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012770-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012770-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012770-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012770-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012770-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012770-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012770-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012770-001	AT	1	`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: hydrocortisone and acetic acid
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETIC ACID	20.75 mg/mL
HYDROCORTISONE	10.375 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q40Q9N063P	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
313786	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
d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
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
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
71656-064-10	hydrocortisone and acetic acid	1 in 1 CARTON	SOLUTION	1		3
71656-064-10	hydrocortisone and acetic acid	10 mL in 1 BOTTLE, DROPPER	SOLUTION	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71656-064-10	ML - Milliliter	71656-064	665de798-37e4-48d7-8f3f-b660b676eb37	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71656-064	HYDROCORTISONE AND ACETIC ACID (HYDROCORTISONE AND ACETIC ACID OTIC) SOLUTION [SAPTALIS PHARMACEUTICALS, LLC]	3	Current NDC, 2 package rows	20250427_d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32.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
hydrocortisone and acetic acid	HYDROCORTISONE AND ACETIC ACID OTIC	Saptalis Pharmaceuticals, LLC	d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012770 application number: NDA012770 ndc (product): 71656-064

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q40Q9N063P	ACETIC ACID	64-19-7	ACETIC ACID
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313786	acetic acid 2 % / hydrocortisone 1 % Otic Solution	PSN	d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32	3
313786	acetic acid 20 MG/ML / hydrocortisone 10 MG/ML Otic Solution	SCD	d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32	3
313786	acetic acid 2 % / hydrocortisone 1 % Otic Solution	SY	d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71656-064-10	71656006410	1 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPER	2024-02-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone and Acetic Acid Otic Solution, USP Rx only	Saptalis Pharmaceuticals, LLC	2025-04-25	HUMAN PRESCRIPTION DRUG LABEL	3