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 93 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join WaxRx EarAcheRx Pain Relieving Drops 4% LIDOCAINE HCL DOCTOR EASY MEDICAL PRODUCTS, LLC 34156655-8706-f0a4-e063-6294a90acc90 2025-05-01 Warnings Exact identifier application number: M017 foster and thrive anti itch cream DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Strategic Sourcing Services LLC bb08293d-5db8-4cc8-9fe3-bd02061dbeb9 2025-04-30 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch LIDOCAINE Solis Pharmaceuticals Inc. 3061d301-2104-b1b2-e063-6394a90a9b6e 2025-04-29 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch LIDOCAINE InterMed Laboratories Private Limited 33ed754e-8852-d5b2-e063-6394a90a7cf2 2025-04-29 Warnings Exact identifier application number: M017 Cold Hot Medicated Patch 5% Menthol MENTHOL InterMed Laboratories Private Limited 33ee6e48-243e-4ded-e063-6394a90a987d 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 32b96689-8e9b-4c2e-e063-6294a90a7d1c 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3304e362-dcda-3f5e-e063-6294a90a7015 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 2f2f753d-c791-e863-e063-6394a90aec5d 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3162c96a-061d-2971-e063-6394a90a9b74 2025-04-29 Warnings Exact identifier application number: M017 Ivarest Poison Ivy Removal and Itch Relief PRAMOXINE HYDROCHLORIDE Blistex Inc. dedbf5d9-0f86-4f32-8321-da86c9838c0a 2025-04-29 Warnings Exact identifier application number: M017 HealthWise 2X Medicated Pain Relief Cream Roll-on MENTHOL Veridian Healthcare 33dae8a8-4197-f276-e063-6294a90aea83 2025-04-28 Warnings Exact identifier application number: M017 HealthWise Roll-on Menthol Pain Relief Gel MENTHOL Veridian Healthcare 33dbb939-9397-7e70-e063-6294a90ac8f4 2025-04-28 Warnings Exact identifier application number: M017 Stopain Extra Strength Gel MENTHOL Troy Manufacturing, Inc. fa1a98bc-c233-410d-a20e-71111c897372 2025-04-28 Warnings Exact identifier application number: M017 Lidocaine Patch 4% LIDOCAINE 4% Medcore LLC b961906c-fe66-466b-af2c-072781fa098b 2025-04-28 Warnings Exact identifier application number: M017 Walgreens Lidocaine Knee and Elbow LIDOCAINE Walgreen Co. a3fb4c78-1493-4ba4-ae83-502dd825ed67 2025-04-25 Warnings Exact identifier application number: M017 Walgreens Lidocaine Back LIDOCAINE Walgreen Co. e6bfd342-c0db-46b9-b5e6-5acbd860adf1 2025-04-25 Warnings Exact identifier application number: M017 Electrum Numb Foam LIDOCAINE HCI RENU LABORATORIES, LLC c8472932-28b7-9189-e053-2a95a90a44df 2025-04-25 Warnings Exact identifier application number: M017 Benadryl Extra Strength Itch Stopping DIPHENHYDRAMINE HYDROCHLORIDE Kenvue Brands LLC 66a2fd60-1757-45cc-a195-ecb9241dca2a 2025-04-24 Warnings Exact identifier application number: M017 Jakwork Numbing Cream NUMBING CREAM Guangzhou Zanming Trading Co., Ltd. 3385cddb-609f-62e8-e063-6294a90add81 2025-04-24 Warnings Exact identifier application number: M017 PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED LIDOCAINE, MENTHOL Compass Health Brands Corp. 2bd8aae0-2606-c7f2-e063-6294a90a9a20 2025-04-22 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