ACETIC ACID

Product NDC
60432-741
11-digit product format
604320741
Labeler code
60432
Product ID
60432-741_65bafc35-2483-4af8-940b-67402c1a2469
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetic Acid
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Morton Grove Pharmaceuticals, Inc.
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60432-741DDiscontinued by firm2026-08-10
excluded packagepackage60432-74160432-741-15DDiscontinued by firm2026-08-10
excluded packagepackage60432-74160432-741-16DDiscontinued by firm2026-08-10

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60432-741-15DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60432-741-16DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60432-741-15IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60432-741-16IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60432-741-15IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60432-741-16IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60432-741-15IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60432-741-16IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60432-741-15IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60432-741-16IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60432-741-15IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60432-741-16IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60432-741-15IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60432-741-16IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60432-741-15IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60432-741-16IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60432-741-15IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60432-741-16IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60432-741-15IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60432-741-16IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60432-741-15IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60432-741-16IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60432-741-15IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60432-741-16IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage60432-741-15IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage60432-741-16IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage60432-741-15IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage60432-741-16IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage60432-741-15IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage60432-741-16IInactivated by FDA1332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040166-001ACETIC ACIDACETIC ACID, GLACIAL2%SOLUTION/DROPS / OTIC1996-07-26

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040166-001ACETIC ACID2%SOLUTION/DROPS / OTICATRS1996-07-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040166-001ACETIC ACID2%SOLUTION/DROPS / OTICATRS1996-07-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040166-001ACETIC ACID2%SOLUTION/DROPS / OTICATRS1996-07-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040166-001ACETIC ACID2%SOLUTION/DROPS / OTICATRS1996-07-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040166-001ACETIC ACID2%SOLUTION/DROPS / OTICATRS1996-07-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040166-001ACETIC ACID2%SOLUTION/DROPS / OTICATRS1996-07-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040166-001ACETIC ACID2%SOLUTION/DROPS / OTICATRS1996-07-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A040166-001ACETIC ACID2%SOLUTION/DROPS / OTICATRS1996-07-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040166-001ACETIC ACID2%SOLUTION/DROPS / OTICATRS1996-07-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040166-001ACETIC ACID2%SOLUTION/DROPS / OTICATRS1996-07-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040166-001ACETIC ACID2%SOLUTION/DROPS / OTICATRS1996-07-263f01610625f2…
2019-09-15 20:21 UTC2019-09A040166-001ACETIC ACID2%SOLUTION/DROPS / OTICATRS1996-07-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A040166-001ACETIC ACID2%SOLUTION/DROPS / OTICATRS1996-07-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040166-001ACETIC ACID2%SOLUTION/DROPS / OTIC1996-07-26cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040166-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040166-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040166-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040166-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040166-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040166-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040166-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A040166-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040166-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040166-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040166-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A040166-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040166-001AT1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-741-15ML - Milliliter60432-741735c6d7f-86d2-45ee-a503-38f67eab1afd12013-02-13
60432-741-16ML - Milliliter60432-7412982a321-5b47-4e6b-903e-5a29f1469c1f12019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETIC ACIDACTIVE INGREDIENTQ40Q9N063PACETIC ACID SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
ACETIC ACIDACTIVE MOIETYQ40Q9N063PACETIC ACID SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLACETIC ACID SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744ACETIC ACID SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETIC ACID SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOL DIACETATEINACTIVE INGREDIENT5Z492UNF9OACETIC ACID SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BACETIC ACID SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-741ACETIC ACID SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]6Legacy NDC20190105_c0ec47b7-c13a-4fa0-91fe-d7a03c70aec9.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETIC ACIDACETIC ACIDChartwell RX, LLC2aaf3781-4f25-4799-8dcd-78d67e226ccc2024-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040166
application number: ANDA040166

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197305acetic acid 2 % Otic SolutionPSNeb6799c0-4ba3-4f30-908d-bd4eb27dc7a94
197305acetic acid 20 MG/ML Otic SolutionSCDeb6799c0-4ba3-4f30-908d-bd4eb27dc7a94
197305acetic acid 2 % Otic SolutionSYeb6799c0-4ba3-4f30-908d-bd4eb27dc7a94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-741-156043207411515 mL in 1 BOTTLE, PLASTIC (60432-741-15) 15 ml1996-07-260000-00-00NoNoCurrent
60432-741-16604320741161 BOTTLE, PLASTIC in 1 CARTON (60432-741-16) > 15 mL in 1 BOTTLE, PLASTIC (60432-741-15) 2019-01-040000-00-00NoNoCurrent