Home NDC 50383-889 Acetic Acid
Product NDC 50383-889
11-digit product format 503830889
Labeler code 50383
Product ID 50383-889_975ebc3f-2649-42c7-8f06-3551b94c5a7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetic Acid
Dosage form SOLUTION
Route AURICULAR (OTIC)
Labeler Akorn
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 No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50383-889-15 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50383-889-15 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50383-889-15 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50383-889-15 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50383-889-15 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50383-889-15 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50383-889-15 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50383-889-15 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50383-889-15 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50383-889-15 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50383-889-15 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50383-889-15 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50383-889-15 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50383-889-15 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50383-889-15 I Inactivated by FDA 1332a3947898…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N012179-001 VOSOL ACETIC ACID, GLACIAL 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS / OTIC RLD, 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 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 N012179-001 VOSOL 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS / OTIC RLD, Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N012179-001 VOSOL 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS / OTIC RLD, Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N012179-001 VOSOL 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS / OTIC RLD, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC RLD, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC RLD, Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC RLD, Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC RLD, Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC RLD, Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC RLD, Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC RLD, Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC RLD, Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC RLD, Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC RLD, Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC RLD, Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT RS, Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT RS, Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT RS, Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT RS, Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT RS, Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT RS, Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT RS, Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT RS, Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT RS, Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT RS, Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N012179-001 VOSOL 2% SOLUTION/DROPS / OTIC AT RS, Approved before 1982 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETIC ACID ACTIVE INGREDIENT Q40Q9N063P ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 ACETIC ACID ACTIVE MOIETY Q40Q9N063P ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 BENZETHONIUM CHLORIDE INACTIVE INGREDIENT PH41D05744 ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 PROPYLENE GLYCOL DIACETATE INACTIVE INGREDIENT 5Z492UNF9O ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B ACETIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 ACETIC ACID ACTIVE INGREDIENT Q40Q9N063P ACETIC ACID SOLUTION [DISPENSING SOLUTIONS, INC.] 2 ACETIC ACID ACTIVE MOIETY Q40Q9N063P ACETIC ACID SOLUTION [DISPENSING SOLUTIONS, INC.] 2 BENZETHONIUM CHLORIDE INACTIVE INGREDIENT PH41D05744 ACETIC ACID SOLUTION [DISPENSING SOLUTIONS, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACETIC ACID SOLUTION [DISPENSING SOLUTIONS, INC.] 2 PROPYLENE GLYCOL DIACETATE INACTIVE INGREDIENT 5Z492UNF9O ACETIC ACID SOLUTION [DISPENSING SOLUTIONS, INC.] 2 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B ACETIC ACID SOLUTION [DISPENSING SOLUTIONS, INC.] 2 ACETIC ACID ACTIVE INGREDIENT Q40Q9N063P ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP] 1 ACETIC ACID ACTIVE MOIETY Q40Q9N063P ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP] 1 BENZETHONIUM CHLORIDE INACTIVE INGREDIENT PH41D05744 ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL DIACETATE INACTIVE INGREDIENT 5Z492UNF9O ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP] 1 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-889 ACETIC ACID SOLUTION [AKORN] 8 Legacy NDC 20220920_c53fc11e-b177-446e-839d-391e1b2eacff.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50383-889-15 50383088915 1 BOTTLE in 1 BOX (50383-889-15) > 15 mL in 1 BOTTLE 1 bottle 2010-01-22 0000-00-00 No No Current