Home NDC 68071-2984 Acetic Acid
Product NDC 68071-2984
11-digit product format 680712984
Labeler code 68071
Product ID 68071-2984_2dcdd631-b9c5-e301-e063-6294a90a038f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetic Acid
Dosage form SOLUTION
Route AURICULAR (OTIC)
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA040607
Marketing category ANDA
Marketing start 2020-06-05
Substance ACETIC ACID
Active strength 20.65 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 6 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 2025-02-02 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 68071-2984-5 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 68071-2984-5 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 68071-2984-5 0efc9e666f02…f202fb6c5f17…
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 A040607-001 ACETIC ACID ACETIC ACID, GLACIAL 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040607-001 AT
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 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT 2005-02-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 20.65 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-2984-5 Acetic Acid 15 mL in 1 BOTTLE SOLUTION 15 2 68071-2984-5 Acetic Acid 1 in 1 CARTON SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2984 ACETIC ACID SOLUTION [NUCARE PHARMACEUTICALS,INC.] 2 Current NDC, 2 package rows 20250212_f9b4d18b-25f3-604f-e053-6394a90a5531.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 · 3 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 68071-2984-5 68071298405 1 BOTTLE in 1 CARTON (68071-2984-5) / 15 mL in 1 BOTTLE 1 bottle 2023-04-19 No No Current