Home NDC 68678-012 Cold Therapy
Product NDC 68678-012
11-digit product format 686780012
Labeler code 68678
Product ID 68678-012_3dd5f406-2bb4-a4f9-e063-6294a90a16b2
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form SPRAY
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 · 56 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 1371206 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 68678-012-04 Cold Therapy 126 mL in 1 BOTTLE, SPRAY SPRAY 126 5 68678-012-16 Cold Therapy 504 mL in 1 BOTTLE, SPRAY SPRAY 504 5 68678-012-32 Cold Therapy 1008 mL in 1 BOTTLE, SPRAY SPRAY 1008 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68678-012 COLD THERAPY (MENTHOL) SPRAY [AHC VENTURES CORP DBA CRYODERM] 4 Current NDC, Legacy NDC, 3 package rows 20220513_dd95c682-8ddf-43e7-a277-2fca6ec744cc.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 26 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr Sabharwals LIDOCAINE 4% GEL PATCH Dr. Sabharwal's Wound Care 102399b6-5be9-ee5e-e063-6394a90a3198 2026-04-02 Warnings Exact identifier application number: M017 TATTOO NUMBX NUMBING PAIN RELIEVING LIDOCAINE HYDROCHLORIDE Scyberco Ltd ac8eac04-ed5b-4c8e-9f9b-54d160b74606 2026-04-02 Warnings Exact identifier application number: M017 FifthPulse Hydrocortisone HYDROCORTISONE WeCare Products LLC f1fcb045-4a15-431b-9617-67eae9f87fbd 2026-04-02 Warnings Exact identifier application number: M017 ANIXIKE Cream MENTHOL 5% CREAM Jiangxi Yudexi Pharmaceutical Co., LTD 4e8510e6-c0c7-bf6b-e063-6294a90a3b00 2026-04-02 Warnings Exact identifier application number: M017 RAPID RELIEF 0.025% CAPSAICIN PAIN PATCH 83569 4ed549e8-0062-fb03-e063-6294a90aac65 2026-04-02 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL AND ZINC ACETATE CVS Pharmacy 7e921988-ec66-38dc-e053-2a91aa0a7346 2026-04-01 Warnings Exact identifier application number: M017 The Best Numbing Cream TBNC The Best Numbing Cream LLC 4ca3923b-f586-0aaf-e063-6294a90a16c1 2026-03-31 Warnings Exact identifier application number: M017 ChapStick Classic Medicated EXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 42798a6c-2d7e-80f6-e063-6294a90a105f 2026-03-31 Warnings Exact identifier application number: M017 Roll-On Pain Relief Liquid LIDOCAINE HCL HyVee Inc 4da6f6fb-b182-360f-e063-6294a90abdf3 2026-03-31 Warnings Exact identifier application number: M017 Hand Sanitizer ALCOHOL ProStat First Aid 4e54aecb-190f-3866-e063-6294a90a810a 2026-03-31 Warnings Exact identifier application number: M017 Burn Mist LIDOCAINE HYDROCHLORIDE Water-Jel Technologies c53ab9dd-351a-400b-b873-4f396e0af54d 2026-03-31 Warnings Exact identifier application number: M017 Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving LIDOCAINE HYDROCHLORIDE Sato Pharmaceutical Co., Ltd. f7faddb2-5153-4fdd-a5ef-778182cef460 2026-03-31 Warnings Exact identifier application number: M017 ZENOL COOL METHYL SALICYLATE, L-MENTHOL BA TRADE INC 4e5c45f4-88ce-3a13-e063-6394a90a2a09 2026-03-31 Warnings Exact identifier application number: M017 Eagle Brand Medicated Roll On Refresh CAMPHOR, MENTHOL Borden Company (Private) Limited 091451fb-e30a-0012-e063-6394a90a3ba8 2026-03-31 Warnings Exact identifier application number: M017 Icy Hot Revive and Recovery Pain Relief No- Mess Roll On Refreshing Lime and Mint MENTHOL Chattem, Inc. b16ba9c2-23bf-4fdf-b44b-7abb9fec1911 2026-03-31 Warnings Exact identifier application number: M017 DR.PABU NUMBING LIDOCAINE 5% NUMBING Jiangxi Yudexi Pharmaceutical Co., LTD 4e3a3c6c-4821-76ea-e063-6294a90a8f96 2026-03-30 Warnings Exact identifier application number: M017 Doctor Jiao Antifungal Cream MICONAZOLE NITRATE Jiangxi Haiwei Pharmaceutical Co., Ltd. 4e3b231e-0642-bf63-e063-6394a90a905b 2026-03-30 Warnings Exact identifier application number: M017 CVS Muscle Balm and Roll-On CAMPHOR, MENTHOL CVS Pharmacy 4e40025a-070a-508e-e063-6394a90af5d7 2026-03-30 Warnings Exact identifier application number: M017 REGENECARE HA LIDOCAINE HCL MPM Medical LLC c3eec066-38e8-4617-b34d-2f72ffb7a324 2026-03-30 Warnings Exact identifier application number: M017 Softlips Naturals Medicated Matcha Honey CAMPHOR, MENTHOL The Mentholatum Company 4e03a721-73f3-b2f2-e063-6394a90a44e6 2026-03-27 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 68678-012-04 68678001204 126 mL in 1 BOTTLE, SPRAY (68678-012-04) 126 ml 2016-01-01 0000-00-00 No No Current 68678-012-16 68678001216 504 mL in 1 BOTTLE, SPRAY (68678-012-16) 504 ml 2016-01-01 0000-00-00 No No Current 68678-012-32 68678001232 1008 mL in 1 BOTTLE, SPRAY (68678-012-32) 1008 ml 2016-01-01 0000-00-00 No No Current