Home NDC 83295-8000 Cinthera
Product NDC 83295-8000
11-digit product format 832958000
Labeler code 83295
Product ID 83295-8000_45af65de-7536-5b6a-e063-6394a90ae189
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine
Dosage form OINTMENT
Route CUTANEOUS
Labeler Strand Health Group
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-20
Substance LIDOCAINE
Active strength .04 g/g
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 Cinthera
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE .04 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2559400 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 83295-8000-1 Cinthera 92 g in 1 TUBE OINTMENT 92 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83295-8000 CINTHERA (LIDOCAINE) OINTMENT [STRAND HEALTH GROUP] 1 Current NDC, 1 package rows 20241121_2746e5b2-be2d-f2d2-e063-6394a90a3690.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 18 of 153 · 3,057 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 83295-8000-1 83295800001 92 g in 1 TUBE (83295-8000-1) 92 g 2024-11-20 No No Current