Home NDC 84638-8201 Pain Relief
Product NDC 84638-8201
11-digit product format 846388201
Labeler code 84638
Product ID 84638-8201_1f44466f-0450-70fe-e063-6294a90ad575
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Pain Relieving Spray Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-31
Substance MENTHOL
Active strength 70 mg/L
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 Pain Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 70 mg/L
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086713 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 84638-8201-1 Pain Relief 0.059 L in 1 BOTTLE, SPRAY AEROSOL, SPRAY 0.059 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84638-8201 PAIN RELIEF (MENTHOL) AEROSOL, SPRAY [PAIN RELIEVING SPRAY INC.] 1 Current NDC, 1 package rows 20250331_1f44466f-044f-70fe-e063-6294a90ad575.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 48 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 84638-8201-1 84638820101 .059 L in 1 BOTTLE, SPRAY (84638-8201-1) 2025-03-31 No No Current