Home NDC 61010-8201 Analgesic
Product NDC 61010-8201
11-digit product format 610108201
Labeler code 61010
Product ID 61010-8201_10981167-c8a2-e068-e063-6394a90ab165
Type HUMAN OTC DRUG
Nonproprietary name menthol
Dosage form SPRAY
Route TOPICAL
Labeler Safetec of America, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-09-01
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 Analgesic
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 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 61010-8201-0 Analgesic 0.059 L in 1 BOTTLE, SPRAY SPRAY 0.059 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-8201 ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20240214_79e3b0e7-4ba5-4b9d-a980-5b6f18dba802.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 88 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tattoo TATTOO CREAM Perfso (HK) Co., Limited 39773cab-12df-4520-e063-6294a90abc5b 2025-07-08 Warnings Exact identifier application number: M017 Neutrogena Sun Rescue After Sun Medicated Relief CAMPHOR (SYNTHETIC) Kenvue Brands LLC c95c5b64-b90f-1143-e053-2a95a90aa03c 2025-07-07 Warnings Exact identifier application number: M017 sunmark Hydrocortisone HYDROCORTISONE Strategic Sourcing Services LLC 210079e9-3d2f-4489-b468-b96b145034ed 2025-07-07 Warnings Exact identifier application number: M017 Relief Gel LIDOCAINE HCL Good Clean Love, Inc. e5fa2265-ccb7-750c-e053-2995a90aa51e 2025-07-07 Warnings Exact identifier application number: M017 Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 09ac2749-a60f-4039-8c80-a0d2eaf50c34 2025-07-07 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 2ada9ec2-1c28-4da2-8639-07b3193ffb32 2025-07-03 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE Sun Pharmaceutical Industries, Inc. caa2fd64-e262-4d7c-ad8a-69f506feba8c 2025-07-03 Warnings Exact identifier application number: M017 Stopain Extra Strength MENTHOL Troy Manufacturing, Inc. 07e9a235-6d10-4407-8729-beaf936e97ad 2025-07-03 Warnings Exact identifier application number: M017 Blue Ice Topical Analgesic Gel ICE GEL International Wholesale 397cd306-078d-5b7d-e063-6294a90a8bbc 2025-07-03 Warnings Exact identifier application number: M017 LIDOCAINE LIDOCAINE, MENTHOL Vive Health LLC 236ccc6d-21b7-6153-e063-6394a90a4634 2025-07-02 Warnings Exact identifier application number: M017 AsperFlex MAX LIDOCAINE 4% WITH MENTHOL 1% Akron Pharma Inc. ccf6172b-350a-4b78-b844-f84bf17c491f 2025-07-02 Warnings Exact identifier application number: M017 METHYL SALICYLATE 25% METHYL SALICYLATE Oncora Pharma, LLC 3766e3a9-94a8-4c3e-e063-6394a90aa24a 2025-07-01 Warnings Exact identifier application number: M017 Diphenhydramine Hydrochloride and Zinc Acetate DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Sun Pharmaceutical Industries, Inc. c89e3de8-7d71-485c-8fc5-2832d6024f16 2025-07-01 Warnings Exact identifier application number: M017 Westlake Outdoor Pain and Itch Relieving LIDOCAINE 4% PAIN AND ITCH RELIEVING WESTLAKE HB PHARMA 3c563b28-4f4f-9d0c-e063-6294a90adf73 2025-07-01 Warnings Exact identifier application number: M017 Cortizone 10 Water Resistant HYDROCORTISONE Chattem, Inc. 118e55e7-241f-44c4-959e-09bf6221bd77 2025-07-01 Warnings Exact identifier application number: M017 Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 38c1616e-3b09-0669-e063-6294a90a2c86 2025-06-29 Warnings Exact identifier application number: M017 Plantar Fasciitis Cream CAMPHOR SOLALIA LLC 388f33c2-2bdf-ded8-e063-6294a90aeeac 2025-06-27 Warnings Exact identifier application number: M017 4 Lidocaine Topical Anesthetic LIDOCAINE RUGBY LABORATORIES 63327e57-f4c8-4ae6-9d28-cef8697bbdcc 2025-06-27 Warnings Exact identifier application number: M017 Diphenhydramine HCl and Zinc Acetate ANTI-ITCH CONTINUOUS SPRAY Wal-Mart Stores, Inc. 709c3bb8-5b36-4823-941a-45ddb3e431c4 2025-06-27 Warnings Exact identifier application number: M017 Burn Relief Professional Bio-Kool LIDOCAINE - 4% Kool-Down Inc. 827e9c69-4706-0ccf-e053-2991aa0aa1c1 2025-06-27 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 61010-8201-0 61010820100 .059 L in 1 BOTTLE, SPRAY (61010-8201-0) 2018-09-01 0000-00-00 No No Current