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 62 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Itch Eraser Gel DIPHENHYDRAMINE HCL Tender Corporation d/b/a Adventure Ready Brands 223c7cfd-6dc5-140a-e063-6394a90a8332 2025-11-17 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY Kroger Co. 6b3e7aac-395f-48cf-9c5e-f7e163724aef 2025-11-17 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY HY-VEE, INC 415ecfe9-3145-f23e-e063-6394a90adfd8 2025-11-17 Warnings Exact identifier application number: M017 AY BENDITO - CBD CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC 04b1d605-60aa-56f4-e063-6294a90ae760 2025-11-17 Warnings Exact identifier application number: M017 AY BENDITO - CBD CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC 0f1406fe-3a2f-bf36-e063-6294a90a7e5e 2025-11-17 Warnings Exact identifier application number: M017 AY BENDITO CBD MENTHOL, CAMPHOR AY BENDITO INTERNATIONAL, INC 30a1c6b7-e37e-32c2-e063-6394a90aa354 2025-11-17 Warnings Exact identifier application number: M017 ETERNAL SPIRIT BEAUTY PAINLESS WITH CBD 3000 MENTHOL, CAMPHOR Worldwide Cosmetics, Inc 0816cc8f-8d0b-de27-e063-6294a90a8a9d 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON COOLING MENTHOL Just Brands LLC f6538e3e-4663-679c-e053-2995a90a87b5 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON WARMING CAMPHOR Just Brands LLC f65455d7-04a9-6217-e053-2995a90a7c90 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD - CBD AND THC ULTRA RELIEF MENTHOL, CAMPHOR Just Brands LLC f664eb79-8897-3a49-e053-2995a90a37b4 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD RELIEF SOOTHING LIDOCAINE HCL Just Brands LLC f9aff6e7-5702-f61c-e053-6294a90aa66f 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD SOOTHING MENTHOL, CAMPHOR Just Brands LLC 0abece07-976c-4881-e063-6294a90a5c1b 2025-11-17 Warnings Exact identifier application number: M017 Blue-Emu Thrive Pain Relief Cream TRIPELENNAMINE 0.5% Kingsway Pharmaceuticals dba NFI, LLC a4ba6787-c99b-4bf2-9f8f-e923ef976212 2025-11-14 Warnings Exact identifier application number: M017 CVS Cooling Patch MENTHOL CVS Pharmacy 42d97e29-f32d-a31b-e063-6394a90a88d8 2025-11-14 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Marlex Pharmaceuticals Inc 4de2bc60-dc4a-4417-984f-eabab0e926a6 2025-11-14 Warnings Exact identifier application number: M017 EXTREME EMU MENTHOL, METHYL SALICYLATE Renu Laboratories, LLC 4393b57b-1e70-b8dd-e063-6294a90ae748 2025-11-14 Warnings Exact identifier application number: M017 4x Medicated Toothache and Gum Cream BENZOCAINE Kroger a8c5090a-24f9-4e73-e053-2a95a90acca0 2025-11-14 Warnings Exact identifier application number: M017 PM Toothache Relief BENZOCAINE CVS 0a5a8cd0-d680-8a0f-e063-6294a90aa65c 2025-11-14 Warnings Exact identifier application number: M017 PM Toothache Relief BENZOCAINE Walgreens e816f742-fba9-3c12-e053-2a95a90a192f 2025-11-14 Warnings Exact identifier application number: M017 4x Medicated Toothache and Gum Cream BENZOCAINE Walgreens a71c2092-4ece-b82e-e053-2995a90ac933 2025-11-14 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