Home NDC 68678-050 Pain Relieving Cold Therapy
Product NDC 68678-050
11-digit product format 686780050
Labeler code 68678
Product ID 68678-050_3dd631dc-3173-b10d-e063-6394a90a9da7
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form GEL
Route TOPICAL
Labeler AHC VENTURES CORP DBA CRYODERM
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-01-01
Substance MENTHOL
Active strength 10 g/100L
NDC exclude flag No
Listing certified through 2026-12-31
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 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68678-050-32 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68678-050-32 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68678-050-32 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68678-050-32 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68678-050-32 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68678-050-32 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68678-050-32 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68678-050-32 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68678-050-32 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68678-050-32 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68678-050-32 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68678-050-32 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68678-050-32 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68678-050-32 1332a3947898…d4bfe170f9cd…
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 Pain Relieving Cold Therapy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 10 g/100L
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68678-050-32 Pain Relieving Cold Therapy 1 L in 1 BOTTLE, DISPENSING GEL 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68678-050 PAIN RELIEVING COLD THERAPY (MENTHOL) GEL [AHC VENTURES CORP DBA CRYODERM] 1 Current NDC, Legacy NDC, 1 package rows 20220504_de0c9a73-dbc0-599e-e053-2a95a90a7986.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 32 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HQLSEY QUIT SMOKING PATCHES QUIT SMOKING PATCHES Hansen Pharmaceutical Investment Co., Limited 4ba317fb-714a-05cb-e063-6394a90a382f 2026-02-25 Warnings Exact identifier application number: M017 Advanced Pain Relief Cream With 5 % Natural Menthol MENTHOL Allure Labs 4bab9c43-86d4-dad2-e063-6394a90ac095 2026-02-25 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Patch MENTHOL, CAMPHOR, METHYL SALICYLATE Walgreen Co. 4223c74a-12fb-51a3-e063-6294a90a0deb 2026-02-25 Warnings Exact identifier application number: M017 Advanced Pain Relief Roll-On Gel With 5% Natural Menthol MENTHOL Allure Labs 4bad597f-acb2-a122-e063-6394a90a9fcf 2026-02-25 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy LIDOCAINE InterMed Laboratories Private Limited 4bade8a9-43bd-b649-e063-6294a90a81da 2026-02-25 Warnings Exact identifier application number: M017 dermaFIT Muscle Retention Cream Strength MENTHOL EX Healthcare Inc. 4620c41a-2187-00f5-e063-6394a90a613c 2026-02-23 Warnings Exact identifier application number: M017 dermaFIT Muscle Retention Cream Sculpt MENTHOL EX Healthcare Inc. 4620d4ca-42e4-eeae-e063-6394a90a5c84 2026-02-23 Warnings Exact identifier application number: M017 dermaFIT Muscle Retention Cream Extra Strength MENTHOL EX Healthcare Inc. 4620ca7a-afe6-d063-e063-6394a90ab5db 2026-02-23 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Sportpharm LLC 9578b39e-3df7-4d75-abd7-f1d5524545e5 2026-02-23 Warnings Exact identifier application number: M017 0.5% LIDOCAINE BURN RELIEF LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. cf723c7b-495d-4bae-942c-561cf28af2d3 2026-02-21 Warnings Exact identifier application number: M017 Swiftalyn Numbing Cream MENTHOL 1% GENUINE INNOVATION LTD 4b2ebff2-2f50-e54b-e063-6294a90aaccb 2026-02-19 Warnings Exact identifier application number: M017 Equate Cold Therapy Pain Relieving MENTHOL Walmart Inc 46a3c9e9-5cd3-4bc4-e063-6394a90a7178 2026-02-19 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL, ZINC ACETATE Meijer, Inc. e11390ec-99a3-4ff1-a3c8-ca909f4f67b5 2026-02-19 Warnings, Adverse reactions Exact identifier application number: M017 Aloe Vera Gel LIDOCAINE HCL, MENTHOL Meijer, Inc. d0cc06c1-c0d5-42f0-82cd-8b704cbe1f46 2026-02-19 Warnings, Adverse reactions Exact identifier application number: M017 MENTHOL, CAMPHOR MENTHOL, CAMPHOR CHEMCO CORPORATION 4b1a0e6f-aa68-421c-e063-6294a90a426e 2026-02-18 Warnings Exact identifier application number: M017 Veiurkiu External Analgesic Cream LIDOCAINE BLOOMWELL GARDENS LLC 40ec5e6f-13dc-de04-e063-6294a90af5d5 2026-02-18 Warnings Exact identifier application number: M017 External Analgesic Cream with Menthol 5% MENTHOL 5% BLOOMWELL GARDENS LLC 402faa27-5305-c73d-e063-6394a90a36f2 2026-02-18 Warnings Exact identifier application number: M017 PAINGEL MENTHOL, METHYL SALICYLATE NACOR BUSINESS GROUP LLC 4b1d55e2-cf83-ffbd-e063-6294a90ad52f 2026-02-18 Warnings Exact identifier application number: M017 Alocane Anti-Itch HYDROCORTISONE 1% Quest Products, LLC 45252043-d41a-3cdd-e063-6394a90aa9e5 2026-02-18 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Medrock Pharmacy LLC 43e00e17-1a48-43db-9589-834568917bbf 2026-02-17 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68678-050-32 68678005032 1 L in 1 BOTTLE, DISPENSING (68678-050-32) 1 l 2016-01-01 0000-00-00 No No Current