Home NDC 62135-801 ACETIC ACID
Product NDC 62135-801
11-digit product format 621350801
Labeler code 62135
Product ID 62135-801_149678b6-1fde-d54e-e063-6394a90a1eaf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ACETIC ACID
Dosage form SOLUTION
Route AURICULAR (OTIC)
Labeler Chartwell RX, LLC
Application ANDA040166
Marketing category ANDA
Marketing start 1996-07-26
Substance ACETIC ACID
Active strength 20 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 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# 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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-801-51 ACETIC ACID 15 mL in 1 BOTTLE SOLUTION 15 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-801 ACETIC ACID SOLUTION [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20240328_2aaf3781-4f25-4799-8dcd-78d67e226ccc.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 Sample Exclude flag Status 62135-801-51 62135080151 15 mL in 1 BOTTLE (62135-801-51) 15 ml 2024-03-25 No No Current