Home NDC 80425-0333 Accucaine
Product NDC 80425-0333
11-digit product format 804250333
Labeler code 80425
Product ID 80425-0333_21da4064-d49a-477e-e063-6394a90acae4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INFILTRATION
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2023-07-26
Substance LIDOCAINE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Accucaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII 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 80425-0333-1 Accucaine 5 mL in 1 AMPULE INJECTION, SOLUTION 5 4 80425-0333-1 Accucaine 1 in 1 CARTON INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0333 ACCUCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 4 Current NDC, 2 package rows 20240912_01679d29-a592-8cbb-e063-6394a90ad82a.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Accucaine LIDOCAINE HYDROCHLORIDE Advanced Rx Pharmacy of Tennessee, LLC 01679d29-a592-8cbb-e063-6394a90ad82a 2024-09-11 Warnings, Adverse reactions Exact identifier ndc (product): 80425-0333
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80425-0333-1 80425033301 1 AMPULE in 1 CARTON (80425-0333-1) / 5 mL in 1 AMPULE 1 ampule 2023-07-26 No No Current