Home NDC 68678-013 Cold Therapy
Product NDC 68678-013
11-digit product format 686780013
Labeler code 68678
Product ID 68678-013_3dd5fb17-c856-952b-e063-6294a90a16b2
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/100mL
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 68678-013-90 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 68678-013-90 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 68678-013-90 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 68678-013-90 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 68678-013-90 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 68678-013-90 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 68678-013-90 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 68678-013-90 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 68678-013-90 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 68678-013-90 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 68678-013-90 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 68678-013-90 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 68678-013-90 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 68678-013-90 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 Cold Therapy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 10 g/100mL
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 259249 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 68678-013-90 Cold Therapy 95 mL in 1 BOTTLE, DISPENSING GEL 95 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68678-013 COLD THERAPY (MENTHOL) GEL [AHC VENTURES CORP DBA CRYODERM] 3 Current NDC, Legacy NDC, 1 package rows 20220505_52fff03e-eba2-4604-a71c-2522468f627b.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 124 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fast Freeze Lidocaine Roll-On LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL Natural Essentials, Inc. 74b06366-5eb4-4eba-aa2b-2b672828294d 2024-10-04 Warnings Exact identifier application number: M017 Fast Freeze Lidocaine LIDOCAINE Natural Essentials, Inc. 029bd3fb-1b5b-48e0-b9af-d91d548b5b0f 2024-10-04 Warnings Exact identifier application number: M017 Fast Freeze MENTHOL Natural Essentials Inc. a96e3e41-871c-4cf3-93b6-af2a6246ded8 2024-10-04 Warnings Exact identifier application number: M017 CVS Pain Relief MENTHOL 4% CVS 20234356-5e80-b79e-e063-6294a90a2ee3 2024-10-04 Warnings Exact identifier application number: M017 FLANAX BACK PAIN RELIEF LIDOCAINE Belmora Llc af4bf57c-f250-4506-83eb-e0f253e96062 2024-10-04 Warnings Exact identifier application number: M017 topcare hydrocortisone HYDROCORTISONE Topco Associates LLC 11a30ec9-ebc2-4a00-8a8d-431d0d973b37 2024-10-03 Warnings Exact identifier application number: M017 pain relief patch LIDOCAINE 4% Bionpharma Inc. 19c69983-4e78-8ec5-e063-6394a90a84be 2024-10-03 Warnings Exact identifier application number: M017 Good Sense Anti Itch HYDROCORTISONE L. Perrigo Company ecd6d841-40b9-42c9-825d-d172cd04824d 2024-10-03 Warnings Exact identifier application number: M017 Gold Bond Medicated Original Strength Body MENTHOL Navajo Manufacturing Company Inc. f71d598c-92c3-d6fd-e053-6394a90a97d7 2024-10-03 Warnings Exact identifier application number: M017 Signature Care Hydrocortisone HYDROCORTISONE Safeway 9e663535-4acc-4b37-acae-8c17517c5a3d 2024-10-03 Warnings Exact identifier application number: M017 Topcare Hydrocortisone HYDROCORTISONE Topco Associates LLC 849c60fc-e455-4c50-8adf-ac59c0ee785b 2024-10-03 Warnings Exact identifier application number: M017 rexall anti itch maximum strength relief HYDROCORTISONE Dolgencorp, LLC 894cf9ab-693a-4210-96df-605947f51b63 2024-10-03 Warnings Exact identifier application number: M017 equaline anti itch maximum strength HYDROCORTISONE United Natural Foods, Inc. dba UNFI 070000d7-7d4d-439b-9a91-851ba7c027e6 2024-10-03 Warnings Exact identifier application number: M017 hydrocortisone anti itch HYDROCORTISONE H E B a1a9fed8-4938-48b5-81f1-d3942d534bb8 2024-10-03 Warnings Exact identifier application number: M017 equaline anti itch HYDROCORTISONE United Natural Foods, Inc. dba UNFI ef9ea069-9b97-4bf5-aaac-deb85334dbd0 2024-10-03 Warnings Exact identifier application number: M017 Basic Care Hydrocortisone HYDROCORTISONE Amazon.com Services LLC 7fa13ab4-5f2d-4a48-816f-1b22d5f757b2 2024-10-03 Warnings Exact identifier application number: M017 hydrocortisone HYDROCORTISONE A-S Medication Solutions dc388dc1-0c4f-4bf1-8a12-fa39892317bc 2024-10-02 Warnings Exact identifier application number: M017 Geliga Muscular MENTHOL, METHYL SALICYLATE PT. EAGLE INDO PHARMA fb2beb08-0ad6-a89d-e053-6294a90aa6fe 2024-10-02 Warnings Exact identifier application number: M017 Geliga Muscular Balm MENTHOL, METHYL SALICYLATE PT. EAGLE INDO PHARMA da28097f-4b5c-6159-e053-2a95a90a7d96 2024-10-02 Warnings Exact identifier application number: M017 Circatrix CAPSAICIN PureTek Corporation cd3b1256-2df8-dc26-e053-2a95a90ad049 2024-10-02 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 Marketing end Sample Exclude flag Status 68678-013-90 68678001390 95 mL in 1 BOTTLE, DISPENSING (68678-013-90) 95 ml 2016-01-01 0000-00-00 No No Current