Home NDC 82645-013 Lidocaine Pain Relief Roll-On
Product NDC 82645-013
11-digit product format 826450013
Labeler code 82645
Product ID 82645-013_4f6d9a5e-1859-f18a-e063-6294a90ace68
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine 4%
Dosage form LIQUID
Route TOPICAL
Labeler Pharma Nobis, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-14
Substance LIDOCAINE HYDROCHLORIDE
Active strength 4 g/100mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Lidocaine Pain Relief Roll-On
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 4 g/100mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010895 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 82645-013-97 Lidocaine Pain Relief Roll-On 1 in 1 CARTON LIQUID 1 1 82645-013-97 Lidocaine Pain Relief Roll-On 74 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 74 1
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 Marketing start Sample Exclude flag Status 82645-013-97 82645001397 1 BOTTLE, WITH APPLICATOR in 1 CARTON (82645-013-97) / 74 mL in 1 BOTTLE, WITH APPLICATOR 2026-04-14 No No Current