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 97 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Herb Analgesic HERB ANALGESIC PASTE Changsha Maocheng Trading Co., Ltd 29373587-9eff-6ea0-e063-6394a90a23b2 2025-03-18 Warnings Exact identifier application number: M017 DEBACHERE Butt Balm After Play Care Multi Symptoms Relief BENZOCAINE, BENZALKONIUM CHLORIDE DE.BACHERE USA LLC f469b446-58a0-4be3-884f-d622b9d074f8 2025-03-17 Warnings Exact identifier application number: M017 Auvon 4% Menthol Pain Relief Gel MENTHOL SHENZHEN YUWEN E-COMMERCE CO., LTD. 2dacd6fe-7d69-bcf0-e063-6294a90a0351 2025-03-14 Warnings Exact identifier application number: M017 Eagle Medicated MENTHOL METHYL SALICYLATE Borden Company (Private) Limited 1ee49cad-84d4-42cf-aa83-c0da6f1b1b84 2025-03-14 Warnings Exact identifier application number: M017 AY BENDITO THERMOACTIVE MENTHOL, CAMPHOR AY BENDITO INTERNATIONAL, INC 304d71b6-91c8-b2b6-e063-6394a90ab669 2025-03-14 Warnings Exact identifier application number: M017 Hot/Cold Medicated Patch HOT COLD PATCH Dynarex 999881b3-287e-d975-e053-2995a90a87e3 2025-03-14 Warnings Exact identifier application number: M017 Capsaicin 0.025% CAPSAICIN 0.025% Marcella Health 3054e7fd-cab2-7f77-e063-6294a90a498d 2025-03-14 Warnings Exact identifier application number: M017 MENTHOL 5% MENTHOL 5% Marcella Health 30914c0a-fbda-5674-e063-6294a90aba5b 2025-03-14 Warnings Exact identifier application number: M017 Peppermint Soothing Patch CAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM Henan Lijitang Medical Technology Co., Ltd. 30361dd4-1f3d-ac5e-e063-6294a90a23bc 2025-03-13 Warnings Exact identifier application number: M017 AVCOO Menthol Pain Relief Patch MENTHOL ADP Health Limited 3036804b-16c3-0c88-e063-6394a90a3084 2025-03-13 Warnings Exact identifier application number: M017 LIDOCAINE 4% LIDOCAINE 4% Marcella Health 303d9462-cbfb-6251-e063-6394a90a7065 2025-03-13 Warnings Exact identifier application number: M017 XeroBurn Burn Gel LIDOCAINE HYDROCHLORIDE Dynarex Corporation 58985046-ca9c-12be-e053-2991aa0abe72 2025-03-13 Warnings Exact identifier application number: M017 Post Treatment Repair Cream HYDROCORTISONE Vege Labs LLC. 302d4327-354b-a252-e063-6394a90a20b6 2025-03-12 Warnings Exact identifier application number: M017 TheraCare Pain Relief 4% Lidocaine LIDOCAINE Veridian Healthcare 2d3fc030-5d53-2acd-e063-6294a90a11ab 2025-03-11 Warnings Exact identifier application number: M017 Cold Hot Medicated Patch 5% Menthol MENTHOL Veridian Healthcare 2d413707-794c-2fa8-e063-6394a90a06bf 2025-03-11 Warnings Exact identifier application number: M017 Cold Hot Medicated Patch 5% Menthol MENTHOL Veridian Healthcare 2d04799f-946d-ac53-e063-6294a90afeb7 2025-03-11 Warnings Exact identifier application number: M017 Muscle and Joint Care LIDOCAINE Vege Labs LLC. 301966b5-b535-dc04-e063-6394a90aec17 2025-03-11 Warnings Exact identifier application number: M017 Arctic Blast Pain Releiving MENTHOL, CAMPHOR (SYNTHETIC) Nutriomo Labs Pte, Ltd d5e7d26d-4f63-4b7b-a173-fe3a794c8459 2025-03-10 Warnings Exact identifier application number: M017 Anti Itch WALGREEN Walgreens 30014ff0-2519-4031-e063-6394a90ae07b 2025-03-10 Warnings Exact identifier application number: M017 Anti Itch ANTI ITCH Neilmed Pharmaceuticals Inc. 2fa74baf-e3d2-e099-e063-6394a90a1bae 2025-03-06 Warnings Exact identifier application number: M017
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