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 136 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rugby Capsaicin External Analgesic CAPSAICIN Proficient Rx LP 7c733a30-5002-49e7-a6bd-7737a1d2461e 2024-02-01 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Proficient Rx LP ccb62898-b614-45b9-95ea-23e5e31893a8 2024-02-01 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE Proficient Rx LP 0b26d92f-9d0e-46d4-a8bc-75d6da5f6199 2024-02-01 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Proficient Rx LP c57d5f8e-5934-4cbb-999a-cdd55e5b105f 2024-02-01 Warnings Exact identifier application number: M017 hydrocortisone HYDROCORTISONE Proficient Rx LP 47e9fe84-bd0c-40ea-85de-e950bcacc557 2024-02-01 Warnings Exact identifier application number: M017 Joint and Muscle Pain MENTHOL Shaklee Corporation 3943824f-1f4f-4d6f-bd73-0b1be02162a5 2024-01-30 Warnings Exact identifier application number: M017 Mirakel Pain Relief Roll-On LIDOCAINE HCL Sanvio, Inc. 102f3618-13ad-37e3-e063-6294a90a8086 2024-01-30 Warnings Exact identifier application number: M017 Blistex Lip Medex PETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOL Blistex Inc. 8ad39005-9419-4f1a-a1ae-2f76d212455e 2024-01-26 Warnings Exact identifier application number: M017 Point Relief Cold Spot Pain Relieving MENTHOL Fabrication Enterprises ad5d6f04-15e6-4548-95c2-32271c186bc1 2024-01-25 Warnings Exact identifier application number: M017 MIND BODY MATRIX PAIN RELIEF MENTHOL Functional Energetic, Inc. 3667dd0d-942e-4101-ba98-cb013ae77cf5 2024-01-25 Warnings Exact identifier application number: M017 SUPER WHITE STUFF Pain Relief MENTHOL BLUE SPRING WELLNESS e6d27df5-118c-4c6d-86e8-7b4401a39c76 2024-01-23 Warnings Exact identifier application number: M017 Burn First Aid BURN FIRST AID Dynarex Corporation 826e08be-dffa-5a27-e053-2a91aa0a8701 2024-01-22 Warnings Exact identifier application number: M017 Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On MENTHOL TARGET CORPORATION 0f95fc55-8665-9e89-e063-6394a90a7891 2024-01-22 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain Relief Plus Menthol LIDOCAINE, MENTHOL, UNSPECIFIED FORM Natural Essentials, Inc. 77978069-a1b4-473e-83c9-8320e00eea89 2024-01-19 Warnings Exact identifier application number: M017 ZIMS MAX FREEZE LEG CRAMPS CAMPHOR, MENTHOL KOBAYASHI Healthcare International, Inc. ba26635d-95d3-4d88-93cc-1fd4fd29fd79 2024-01-18 Warnings Exact identifier application number: M017 Burn LIDOCAINE HART Health e95ebdac-9789-41c2-97da-2307e4538794 2024-01-18 Warnings Exact identifier application number: M017 Medi-First Hydrocortisone 1% HYDROCORTISONE ACETATE Unifirst First Aid Corporation bd216f5d-f304-7d8d-e053-2a95a90aa9ce 2024-01-17 Warnings Exact identifier application number: M017 Green Guard Hydrocortisone 1% HYDROCORTISONE Unifirst First Aid Corporation bd348e2a-57b1-3f17-e053-2a95a90a8bdc 2024-01-17 Warnings Exact identifier application number: M017 Pain Relief LIDOCAINE, MENTHOL HUMN Pharmaceuticals Inc 6c96f94a-e724-eab3-e053-2991aa0aab88 2024-01-17 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain Relief LIDOCAINE Natural Essentials, Inc. 52e82e70-53b7-4ecb-be39-fe10c94cc444 2024-01-17 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