acetic acid

Product NDC
21695-222
11-digit product format
216950222
Labeler code
21695
Product ID
21695-222_a8c12387-4b2b-49c2-b9c5-112ffb133950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetic acid
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Rebel Distributors Corp
Application
NDA012179
Marketing category
NDA
Marketing start
2010-01-22
Marketing end
0000-00-00
Substance
ACETIC ACID
Active strength
21 mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-222IInactivated by FDA2026-08-10
excluded packagepackage21695-22221695-222-15IInactivated by FDA2026-08-10

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-222-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-222-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-222-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-222-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-222-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-222-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-222-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-222-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-222-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-222-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-222-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-222-15557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-222-158af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-222-15834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-222-151332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-222-15fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-222-1586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-222-15bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-222-158dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-222-15e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-222-159bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-222-15110d247fa046…a55b01930146…

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
N012179-001VOSOLACETIC ACID, GLACIAL2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OTICRLD, Approved before 1982

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 UTC2026-02N012179-001VOSOL2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OTICRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012179-001VOSOL2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OTICRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N012179-001VOSOL2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OTICRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N012179-001VOSOL2%SOLUTION/DROPS / OTICRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N012179-001VOSOL2%SOLUTION/DROPS / OTICRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N012179-001VOSOL2%SOLUTION/DROPS / OTICRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N012179-001VOSOL2%SOLUTION/DROPS / OTICRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N012179-001VOSOL2%SOLUTION/DROPS / OTICRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N012179-001VOSOL2%SOLUTION/DROPS / OTICRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N012179-001VOSOL2%SOLUTION/DROPS / OTICRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N012179-001VOSOL2%SOLUTION/DROPS / OTICRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N012179-001VOSOL2%SOLUTION/DROPS / OTICRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N012179-001VOSOL2%SOLUTION/DROPS / OTICRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N012179-001VOSOL2%SOLUTION/DROPS / OTICRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N012179-001VOSOL2%SOLUTION/DROPS / OTICATApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N012179-001VOSOL2%SOLUTION/DROPS / OTICATApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N012179-001VOSOL2%SOLUTION/DROPS / OTICATApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N012179-001VOSOL2%SOLUTION/DROPS / OTICATApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N012179-001VOSOL2%SOLUTION/DROPS / OTICATApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N012179-001VOSOL2%SOLUTION/DROPS / OTICATApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N012179-001VOSOL2%SOLUTION/DROPS / OTICATApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N012179-001VOSOL2%SOLUTION/DROPS / OTICATApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N012179-001VOSOL2%SOLUTION/DROPS / OTICATApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N012179-001VOSOL2%SOLUTION/DROPS / OTICATApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N012179-001VOSOL2%SOLUTION/DROPS / OTICATApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N012179-001VOSOL2%SOLUTION/DROPS / OTICATApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N012179-001VOSOL2%SOLUTION/DROPS / OTICATApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N012179-001VOSOL2%SOLUTION/DROPS / OTICATRS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N012179-001VOSOL2%SOLUTION/DROPS / OTICATRS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N012179-001VOSOL2%SOLUTION/DROPS / OTICATRS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N012179-001VOSOL2%SOLUTION/DROPS / OTICATRS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N012179-001VOSOL2%SOLUTION/DROPS / OTICATRS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N012179-001VOSOL2%SOLUTION/DROPS / OTICATRS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N012179-001VOSOL2%SOLUTION/DROPS / OTICATRS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N012179-001VOSOL2%SOLUTION/DROPS / OTICATRS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N012179-001VOSOL2%SOLUTION/DROPS / OTICATRS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N012179-001VOSOL2%SOLUTION/DROPS / OTICATRS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N012179-001VOSOL2%SOLUTION/DROPS / OTICATRS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N012179-001VOSOL2%SOLUTION/DROPS / OTICATRS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012179-001VOSOL2%SOLUTION/DROPS / OTICATRS, Approved before 1982cb3db0bc1861…

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 ZIP2022-06N012179-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N012179-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N012179-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N012179-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N012179-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N012179-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N012179-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N012179-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N012179-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N012179-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N012179-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N012179-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N012179-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N012179-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N012179-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N012179-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N012179-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N012179-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N012179-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N012179-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N012179-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N012179-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N012179-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N012179-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N012179-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012179-001AT1cb3db0bc1861…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-222-152019-09-24C16284748780-1934fe258-4a2b-48b1-e053-8cdaa90a720aAcetic Acid Otic Solution, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-222-15acetic acid15 mL in 1 BOTTLESOLUTION151
21695-222-15acetic acid1 in 1 BOXSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-222-15ML - Milliliter21695-222df822605-35fe-4273-83a6-18277fff83ca12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETIC ACIDACTIVE INGREDIENTQ40Q9N063PACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP]1
ACETIC ACIDACTIVE MOIETYQ40Q9N063PACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP]1
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOL DIACETATEINACTIVE INGREDIENT5Z492UNF9OACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-222ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120222_a8c12387-4b2b-49c2-b9c5-112ffb133950.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 ACIDNuCare Pharmaceuticals,Inc.7470a1ed-bc00-cb52-e053-2a91aa0a5c7d2024-07-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 012179
application number: NDA012179

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197305acetic acid 2 % Otic SolutionPSNa8c12387-4b2b-49c2-b9c5-112ffb1339501
197305acetic acid 20 MG/ML Otic SolutionSCDa8c12387-4b2b-49c2-b9c5-112ffb1339501
197305acetic acid 2 % Otic SolutionSYa8c12387-4b2b-49c2-b9c5-112ffb1339501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-222-152169502221515 mL in 1 BOTTLE15 mlHistorical