Home NDC 83016-171 Pain Relief Gel-Patch
Product NDC 83016-171
11-digit product format 830160171
Labeler code 83016
Product ID 83016-171_25ac4fb1-be51-69e9-e063-6394a90a7a64
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine, Menthol
Dosage form PATCH
Route TOPICAL
Labeler R & Y Group, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-15
Substance MENTHOL; LIDOCAINE
Active strength .12; .48 g/12g; g/12g
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 Pain Relief Gel-Patch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL .12 g/12g LIDOCAINE .48 g/12g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup 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 1249758 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 83016-171-01 Pain Relief Gel-Patch 12 g in 1 PACKET PATCH 12 2 83016-171-07 Pain Relief Gel-Patch 7 in 1 POUCH PATCH 7 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83016-171 PAIN RELIEF GEL-PATCH (LIDOCAINE, MENTHOL) PATCH [R & Y GROUP, LLC] 2 Current NDC, 2 package rows 20241031_fe0478d8-2f06-cd56-e053-6294a90a58e5.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 83016-171-01 83016017101 12 g in 1 PACKET 12 g Historical 83016-171-07 83016017107 7 PACKET in 1 POUCH (83016-171-07) / 12 g in 1 PACKET (83016-171-01) 7 packet 2023-06-15 No No Current