Home NDC 50090-6527-0 Acetic Acid
Product NDC 50090-6527
Requested package NDC 50090-6527-0
11-digit product format 500906527
Labeler code 50090
Product ID 50090-6527_9e3367b4-c357-4ecf-90da-5fd1da2bc2b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetic Acid
Dosage form SOLUTION
Route AURICULAR (OTIC)
Labeler A-S Medication Solutions
Application ANDA040607
Marketing category ANDA
Marketing start 2020-06-01
Substance ACETIC ACID
Active strength 20.65 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 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.
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 2026-08-01 22:54:32 2026-06 A040607-001 ACETIC ACID 2% SOLUTION/DROPS / OTIC AT RS 2005-02-24 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A040607-001 AT 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Acetic Acid
Listing expiration 2027-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-6527-0 Acetic Acid 1 in 1 CARTON SOLUTION 1 3 50090-6527-0 Acetic Acid 15 mL in 1 BOTTLE SOLUTION 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6527 ACETIC ACID SOLUTION [A-S MEDICATION SOLUTIONS] 1 Current NDC, 2 package rows 20230621_c1c28375-9b03-4590-9d39-ab28403da93d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-6527-0 50090652700 1 BOTTLE in 1 CARTON (50090-6527-0) / 15 mL in 1 BOTTLE 1 bottle 2023-06-15 No No Current