Home NDC 71656-064-10 hydrocortisone and acetic acid
Product NDC 71656-064
Requested package NDC 71656-064-10
11-digit product format 716560064
Labeler code 71656
Product ID 71656-064_339e0417-4d1a-e168-e063-6294a90a50bb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocortisone and acetic acid otic
Dosage form SOLUTION
Route AURICULAR (OTIC)
Labeler Saptalis Pharmaceuticals, LLC
Application NDA012770
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2024-02-23
Substance ACETIC ACID; HYDROCORTISONE
Active strength 20.75; 10.375 mg/mL; mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 N012770-001 VOSOL HC ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N012770-001 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 N012770-001 VOSOL HC 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS, Approved before 1982 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 N012770-001 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base hydrocortisone and acetic acid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETIC ACID 20.75 mg/mL HYDROCORTISONE 10.375 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q40Q9N063P Internal UNII lookup WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313786 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 71656-064-10 hydrocortisone and acetic acid 1 in 1 CARTON SOLUTION 1 3 71656-064-10 hydrocortisone and acetic acid 10 mL in 1 BOTTLE, DROPPER SOLUTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71656-064 HYDROCORTISONE AND ACETIC ACID (HYDROCORTISONE AND ACETIC ACID OTIC) SOLUTION [SAPTALIS PHARMACEUTICALS, LLC] 3 Current NDC, 2 package rows 20250427_d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71656-064-10 71656006410 1 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPER 2024-02-23 No No Current