Home NDC 69204-027 Extra Strength
Product NDC 69204-027
11-digit product format 692040027
Labeler code 69204
Product ID 69204-027_297f0ddf-6d38-b182-e063-6394a90a6570
Type HUMAN OTC DRUG
Nonproprietary name Menthol and Methyl Salicylate
Dosage form OIL
Route TOPICAL
Labeler NATURES FORMULAE HEALTH PRODUCTS LTD.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-05-13
Substance MENTHOL; METHYL SALICYLATE
Active strength 94.41; 123.74 mg/mL; mg/mL
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 Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 94.41 mg/mL METHYL SALICYLATE 123.74 mg/mL
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 LAV5U5022Y Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69204-027-01 Extra Strength 1 in 1 BOX OIL 1 2 69204-027-01 Extra Strength 45 mL in 1 BOTTLE, WITH APPLICATOR OIL 45 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69204-027 EXTRA STRENGTH (MENTHOL AND METHYL SALICYLATE) OIL [NATURES FORMULAE HEALTH PRODUCTS LTD.] 2 Current NDC, Legacy NDC, 2 package rows 20241220_d919b50a-5de2-1830-e053-2a95a90ab88d.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 100 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Signature Care Medicated Pain Relief Patch LIDOCAINE Safeway, Inc. 2165a342-5f8b-78e0-e063-6394a90a06c4 2025-02-12 Warnings Exact identifier application number: M017 CheeZheng Pain Relieveing Plaster CAMPHOR Tibet Cheezheng Tibetan Medicine Co. Ltd. abcebdf1-9037-4094-93e1-ce8f20b18ea7 2025-02-11 Warnings Exact identifier application number: M017 Tibetree Pain Relieveing Medicated Plaster CAMPHOR Tibet Cheezheng Tibetan Medicine Co. Ltd 4216bd48-5c62-4e87-adcc-67bf7152d64d 2025-02-11 Warnings Exact identifier application number: M017 AsperFlex LIDOCAINE Akron Pharma Inc. ab50525e-b534-452b-8c25-2992c0cbf862 2025-02-10 Warnings Exact identifier application number: M017 Olu Pain Management LIDOCAINE AND CAMPHOR Olakino Therapeutics LLC 2a41a621-c6f7-5819-e063-6394a90ae67d 2025-02-07 Warnings Exact identifier application number: M017 Pain Reliveing Patch LIDOCAINE 4% simple diagnostics 02ed0b27-bba9-ec0c-e063-6294a90a014d 2025-02-07 Warnings Exact identifier application number: M017 FlexDermal Pain Relieving Roll-On MENTHOL SOLVADERM LLC d4d8050e-0761-4491-8635-39c806701eb5 2025-02-06 Warnings Exact identifier application number: M017 Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine LIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINE Clarion Brands LLC 2d7e9f6a-0f21-b103-e063-6294a90a912f 2025-02-06 Warnings Exact identifier application number: M017 signature care Hydrocortisone HYDROCORTISONE Safeway 9fe16fc5-77e3-47f5-a943-85bc6565c0d4 2025-02-06 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate TROLAMINE SALICYLATE TELEBRANDS CORP 2d685602-5cd6-3b36-e063-6394a90a3c5d 2025-02-05 Warnings Exact identifier application number: M017 Lidocore LIDOCAINE iON Pharma, LLC 204c3e50-1ac8-f442-e063-6294a90ae7b5 2025-02-05 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream Extreme MENTHOL 16%, CAMPHOR 11% Telebrands Corp 2d54077e-4c8d-aaae-e063-6394a90adb41 2025-02-04 Warnings Exact identifier application number: M017 Capsaicin External Analgesic CAPSAICIN NuCare Pharmaceuticals,Inc. fd90a67d-d60d-a849-e053-6394a90a2cc8 2025-02-04 Warnings Exact identifier application number: M017 Rugby Muscle Rub Cream MUSCLE RUB CREAM NuCare Pharmaceuticals, Inc. 2d58c15a-5ddb-1b16-e063-6294a90a3fbb 2025-02-04 Warnings Exact identifier application number: M017 Cetilar MENTHOL 1.4% PharmaNutra Usa Corp. 2dd14bd4-b4e1-bc7d-e063-6394a90a1e59 2025-02-04 Warnings Exact identifier application number: M017 Stopain Extra Strength Continuous MENTHOL Troy Manufacturing, Inc. 0d199d39-5b47-4c7f-b83a-757f39aa17b6 2025-02-03 Warnings Exact identifier application number: M017 TheraCare Pain Relieving Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare 2d42192b-8889-a896-e063-6294a90a4fc8 2025-02-03 Warnings Exact identifier application number: M017 Tiger Balm Pain Relieving Muscle METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) Haw Par Healthcare Ltd. 96b06d3f-8685-4314-ad7d-5d2720f4dde6 2025-02-03 Warnings Exact identifier application number: M017 Icy Hot Medicated No Mess Applicator MENTHOL Chattem, Inc. 4ce2b823-7ef5-4cca-a2d8-2fe781bc958e 2025-02-01 Warnings Exact identifier application number: M017 Cortizone 10 Intensive Healing Itch Relief Cream HYDROCORTISONE Chattem, Inc. cdbeb825-3152-4f74-9fd1-93bccfc0e31a 2025-02-01 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69204-027-01 69204002701 1 BOTTLE, WITH APPLICATOR in 1 BOX (69204-027-01) / 45 mL in 1 BOTTLE, WITH APPLICATOR 2019-05-13 0000-00-00 No No Current