Home NDC 61010-8200 Analgesic
Product NDC 61010-8200
11-digit product format 610108200
Labeler code 61010
Product ID 61010-8200_12b7defb-8710-5fd7-e063-6294a90a8a03
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 2011-10-26
Substance MENTHOL, UNSPECIFIED FORM
Active strength 70 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 61010-8200-1 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 61010-8200-1 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 61010-8200-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 61010-8200-1 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 61010-8200-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 61010-8200-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 61010-8200-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 61010-8200-1 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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, UNSPECIFIED FORM 70 mg/mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086713 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-8200-1 Analgesic 118 mL in 1 BOTTLE, SPRAY SPRAY 118 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded menthol ACTIVE INGREDIENT L7T10EIP3A ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.] 1 menthol ACTIVE MOIETY L7T10EIP3A ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.] 1 coconut oil INACTIVE INGREDIENT Q9L0O73W7L ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.] 1 eucalyptus oil INACTIVE INGREDIENT 2R04ONI662 ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.] 1 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.] 1 methyl salicylate INACTIVE INGREDIENT LAV5U5022Y ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.] 1 peppermint oil INACTIVE INGREDIENT AV092KU4JH ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-8200 ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20240410_b0f4010c-995f-40e1-aa40-92760e697a61.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 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Lidocaine Patch LIDOCAINE Shenzhen Finona Information Technology Co., Ltd 3875bde5-2e1a-5fdf-e063-6294a90a3c0d 2025-06-26 Warnings Exact identifier application number: M017 SupreH Bee Venom Arthritis Pain Relieving Cream SUPREH BEE VENOM ARTHRITIS PAIN RELIEVING CREAM Shenzhen Xinxin Yunhai Technology Co., Ltd. 3876cc44-7f3a-b084-e063-6294a90a6142 2025-06-26 Warnings Exact identifier application number: M017 MediBalm HYDROCORTISONE BalmRx, LLC 324dd151-84c5-3e2f-e063-6394a90a569d 2025-06-26 Warnings Exact identifier application number: M017 PHIZICO Pain Relief MENTHOL ER3 BRANDS INC. 72715dc5-d1e7-4b4b-8e28-4e367abba322 2025-06-25 Warnings Exact identifier application number: M017 Diva Cramp Care Cream METHYL SALICYLATE, MENTHOL, CAMPHOR Avaria Health & Beauty Corp 37368566-b14e-4d5c-bdde-6eea9073974f 2025-06-25 Warnings Exact identifier application number: M017 H2Ocean NOTHING TATTOO GLIDE AFTERCARE MAX STRENGTH LIDOCAINE HCL H2Ocean, LLC 386bf11b-1d71-44bf-e063-6394a90a2817 2025-06-25 Warnings Exact identifier application number: M017 Burn Relief Extra Strength Kool-Down LIDOCAINE - 3.9% Kool-Down Inc 827fec2f-db3c-adbb-e053-2a91aa0a7c17 2025-06-25 Warnings Exact identifier application number: M017 Hilook Blue Gel Anesthetic LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 1b9db681-a297-5aa9-e063-6394a90a80ea 2025-06-25 Warnings Exact identifier application number: M017 Hilook Numbing Cream LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 1b9f1a4c-ca0b-d820-e063-6394a90a3239 2025-06-25 Warnings Exact identifier application number: M017 Lidocaine Knee Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 384c1ff8-80bd-86cb-e063-6394a90a2d65 2025-06-24 Warnings Exact identifier application number: M017 Aroamas Cot Nicotine Transdermal Patches Kit NICOTINE TRANSDERMAL PATCHES PCHEERY LLC 38576022-9413-c9af-e063-6294a90afd46 2025-06-24 Warnings Exact identifier application number: M017 NERVE REVERSE PAIN RELIEF MENTHOL Pogue Medical Services da97bcc6-5aa8-48e2-a2c2-c937745bf6d3 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief Menthol Roll-On MENTHOL Respect Manufacturing Corporation 05a6067a-287a-52d4-e063-6394a90a2c4e 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief 500mg Hemp Menthol Cream MENTHOL Respect Manufacturing Corporation 06c4640a-ee42-5d1a-e063-6394a90ad254 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief 1000mg Hemp Menthol Cream MENTHOL Respect Manufacturing Corporation 06e944e8-71f6-9fe9-e063-6294a90a8c37 2025-06-23 Warnings Exact identifier application number: M017 Procure gel MENTHOL TWIN MED, LLC e69c0b68-d408-9fd2-e053-2a95a90ac934 2025-06-20 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 61010-8200-1 61010820001 118 mL in 1 BOTTLE, SPRAY (61010-8200-1) 118 ml 2011-10-26 No No Current