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 124 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eagle Medicated MENTHOL METHYL SALICYLATE Eagle Indo Pharma, PT da338796-de9c-be51-e053-2a95a90a2509 2024-10-07 Warnings Exact identifier application number: M017 Eagle Medicated MENTHOL METHYL SALICYLATE Eagle Indo Pharma e2c5f821-cdd5-190d-e053-2a95a90a9159 2024-10-07 Warnings Exact identifier application number: M017 NanoXtreme Pain Relieving MENTHOL, METHYL SALICYLATE MG Science Technologies LLC c1490c30-a9db-4120-adaf-9e8000169e46 2024-10-07 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc ea656cf8-cad5-4fa5-82e7-daec77a0bb04 2024-10-07 Warnings Exact identifier application number: M017 Eagle Medicated Oil Refreshing MENTHOL, METHYL SALICYLATE Eagle Indo Pharma, PT e2729023-d689-7ae2-e053-2a95a90a78dc 2024-10-06 Warnings Exact identifier application number: M017 Flanax Back Pain Relief LIDOCAINE Belmora LLC 46d33346-e582-4af1-b81a-feca7033dceb 2024-10-04 Warnings Exact identifier application number: M017 Muscle Balm MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC) Natural Essentials, Inc. 16918ba3-2e07-4232-9ed3-4c7751796cd2 2024-10-04 Warnings Exact identifier application number: M017 Fast Freeze Pain Relieving Continuous MENTHOL, UNSPECIFIED FORM Natural Essentials, Inc. 998a4824-9ed9-4fe0-b45b-72e52861fcd3 2024-10-04 Warnings Exact identifier application number: M017 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
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