Home NDC 80425-0369 Calypxo Pain Relief
Product NDC 80425-0369
11-digit product format 804250369
Labeler code 80425
Product ID 80425-0369_2a994ea2-2575-6513-e063-6394a90a7bc2
Type HUMAN OTC DRUG
Nonproprietary name Methyl Salicylate, Menthol
Dosage form CREAM
Route TOPICAL
Labeler Advanced Rx of Tennessee, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-01
Substance METHYL SALICYLATE; MENTHOL
Active strength 10; 3 g/100g; g/100g
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 Calypxo Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYL SALICYLATE 10 g/100g MENTHOL 3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LAV5U5022Y Internal UNII lookup 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 1486874 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 80425-0369-1 Calypxo Pain Relief 113 g in 1 BOTTLE CREAM 113 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0369 CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ADVANCED RX OF TENNESSEE, LLC] 2 Current NDC, 1 package rows 20250101_0b7736df-c7e0-7d00-e063-6294a90aa57e.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 80425-0369-1 80425036901 113 g in 1 BOTTLE (80425-0369-1) 113 g 2023-12-01 No No Current