Acetic Acid

Product NDC: 50436-4600
11-digit product format: 504364600
Labeler code: 50436
Product ID: 50436-4600_33d9d737-7a48-4a25-9fe5-6387897b43b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetic Acid
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: Unit Dose Services
Application: ANDA040166
Marketing category: ANDA
Marketing start: 1996-07-26
Marketing end: 0000-00-00
Substance: ACETIC ACID
Active strength: 20 mg/mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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	50436-4600		I	Inactivated by FDA		2026-08-10
excluded package	package	50436-4600	50436-4600-1	I	Inactivated by FDA		2026-08-10

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 · 38 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	50436-4600-1	`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	50436-4600-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-4600-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-4600-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-4600-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-4600-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-4600-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-4600-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-4600-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-4600-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-4600-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-4600-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-4600-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-4600-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-4600-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50436-4600-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50436-4600-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50436-4600-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50436-4600-1	`8dfbde2a14a4…`	`c9ff85d89658…`

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
A040166-001	ACETIC ACID	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS / OTIC			1996-07-26

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	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040166-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040166-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040166-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040166-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040166-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040166-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040166-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040166-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040166-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040166-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040166-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040166-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040166-001	AT	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-4600-1	2021-01-29	C162847	48780-1	ba0f9c33-2cbb-a910-e053-dadaa90a0b85	ACETIC ACID OTIC SOLUTION USP, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-4600-1	Acetic Acid	15 mL in 1 BOTTLE	SOLUTION	15		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-4600	ACETIC ACID SOLUTION [UNIT DOSE SERVICES]	4	Legacy NDC, 1 package rows	20171125_eb6799c0-4ba3-4f30-908d-bd4eb27dc7a9.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
ACETIC ACID	ACETIC ACID	Chartwell RX, LLC	2aaf3781-4f25-4799-8dcd-78d67e226ccc	2024-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040166 application number: ANDA040166

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	eb6799c0-4ba3-4f30-908d-bd4eb27dc7a9	4
197305	acetic acid 20 MG/ML Otic Solution	SCD	eb6799c0-4ba3-4f30-908d-bd4eb27dc7a9	4
197305	acetic acid 2 % Otic Solution	SY	eb6799c0-4ba3-4f30-908d-bd4eb27dc7a9	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50436-4600-1	50436460001	15 mL in 1 BOTTLE	15 ml	Historical