Acetic Acid

Product NDC: 52817-816
11-digit product format: 528170816
Labeler code: 52817
Product ID: 52817-816_2a4574f2-001a-ad0a-e063-6394a90a98f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetic Acid
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: TruPharma, LLC
Application: ANDA040607
Marketing category: ANDA
Marketing start: 2020-06-01
Substance: ACETIC ACID
Active strength: 20.65 mg/mL
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
A040607-001	ACETIC ACID	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A040607-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	2005-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040607-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT		2005-02-24	`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	A040607-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040607-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040607-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040607-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040607-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040607-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040607-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040607-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040607-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040607-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040607-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040607-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040607-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040607-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040607-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040607-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040607-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040607-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040607-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040607-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040607-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040607-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040607-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040607-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040607-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040607-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040607-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040607-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040607-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040607-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040607-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040607-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040607-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040607-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040607-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040607-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040607-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040607-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040607-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040607-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acetic Acid
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETIC ACID	20.65 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q40Q9N063P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197305	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
0c5ebd59-0e98-4ea1-b279-9202a19f6dbf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52817-816-15	Acetic Acid	15 mL in 1 BOTTLE	SOLUTION	15		2
52817-816-15	Acetic Acid	1 in 1 CARTON	SOLUTION	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52817-816-15	ML - Milliliter	52817-816	03567882-4160-4c16-8ea4-b074335594ae	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52817-816	ACETIC ACID SOLUTION [TRUPHARMA, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20241228_0c5ebd59-0e98-4ea1-b279-9202a19f6dbf.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
Acetic Acid	ACETIC ACID	A-S Medication Solutions	c1c28375-9b03-4590-9d39-ab28403da93d	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040607 application number: ANDA040607
Acetic Acid	ACETIC ACID	NuCare Pharmaceuticals,Inc.	f9b4d18b-25f3-604f-e053-6394a90a5531	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040607 application number: ANDA040607
Acetic Acid	ACETIC ACID	TruPharma, LLC	0c5ebd59-0e98-4ea1-b279-9202a19f6dbf	2024-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040607 application number: ANDA040607 ndc (product): 52817-816

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q40Q9N063P	ACETIC ACID	64-19-7	ACETIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197305	acetic acid 2 % Otic Solution	PSN	c1c28375-9b03-4590-9d39-ab28403da93d	3
197305	acetic acid 20 MG/ML Otic Solution	SCD	c1c28375-9b03-4590-9d39-ab28403da93d	3
197305	acetic acid 2 % Otic Solution	SY	c1c28375-9b03-4590-9d39-ab28403da93d	3
197305	acetic acid 2 % Otic Solution	PSN	0c5ebd59-0e98-4ea1-b279-9202a19f6dbf	2
197305	acetic acid 2 % Otic Solution	PSN	f9b4d18b-25f3-604f-e053-6394a90a5531	2
197305	acetic acid 20 MG/ML Otic Solution	SCD	0c5ebd59-0e98-4ea1-b279-9202a19f6dbf	2
197305	acetic acid 20 MG/ML Otic Solution	SCD	f9b4d18b-25f3-604f-e053-6394a90a5531	2
197305	acetic acid 2 % Otic Solution	SY	0c5ebd59-0e98-4ea1-b279-9202a19f6dbf	2
197305	acetic acid 2 % Otic Solution	SY	f9b4d18b-25f3-604f-e053-6394a90a5531	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52817-816-15	52817081615	1 BOTTLE in 1 CARTON (52817-816-15) / 15 mL in 1 BOTTLE	1 bottle	2020-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetic Acid Otic Solution, USP	A-S Medication Solutions	2026-03-18	HUMAN PRESCRIPTION DRUG LABEL	3
Acetic Acid Otic Solution, USP	NuCare Pharmaceuticals,Inc.	2025-02-10	HUMAN PRESCRIPTION DRUG LABEL	2
Acetic Acid Otic Solution, USP	TruPharma, LLC \| Saptalis Pharmaceuticals, LLC	2024-12-27	HUMAN PRESCRIPTION DRUG LABEL	2