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 147 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Valtrum Aerobic Sports SALICYLIC ACID MENTHOL CAMPHOR (NATURAL) LABORATORIOS QUANTIUM LLC 33f2491e-c1f2-4e5a-acbe-8ace844b88d6 2023-11-09 Warnings Exact identifier application number: M017 Valtrum Topical Analgesic Roll On SALICYLIC ACID MENTHOL CAMPHOR (NATURAL) LABORATORIOS QUANTIUM LLC 28167e2a-9afb-44e7-90c7-9577df9504b6 2023-11-09 Warnings Exact identifier application number: M017 Satohap Cool Type CAMPHOR, MENTHOL, METHYL SALICYLATE Sato Pharmaceutical Co., Ltd. fe07a00a-2699-44d3-887d-bd068948ad7b 2023-11-07 Warnings Exact identifier application number: M017 Hims Delay Wipes BENZOCAINE WIPES Hims Inc. adbead3d-dca0-4919-b688-44c88f779e5a 2023-11-07 Warnings Exact identifier application number: M017 Bakers Best Maximum Strength Pain Relief LIDOCAINE HYDROCHLORIDE, MENTHOL Baker's Best Health Products, LLC 9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d 2023-11-06 Warnings Exact identifier application number: M017 BAKERS BEST Pain Relief with Pure Hemp Seed Oil LIDOCAINE HYDROCHLORIDE, MENTHOL BAKER'S BEST HEALTH PRODUCTS, INC. ae54c234-bfe4-4a74-b293-db7efda7884b 2023-11-06 Warnings Exact identifier application number: M017 Arth RX Topical Analgesic METHYL NICOTINATE, CAPSAICIN HCD Sales a7b3b9b4-b1c4-4e51-8e3a-c84f64c75609 2023-11-06 Warnings Exact identifier application number: M017 BAKERS BEST Arthritis Pain Relief Cream with Hemp and Lavender HISTAMINE DIHYDROCHLORIDE BAKER'S BEST HEALTH PRODUCTS, INC. 03ec87c5-6669-4afb-8d9c-c8dc9907495d 2023-11-06 Warnings Exact identifier application number: M017 DOCTORS TOUCH Erase The Pain MENTHOL DOCTOR'S CHOICE MEDICAL, LLC fe9ce2c7-d6af-4dad-b6e6-5049a9e091b0 2023-11-06 Warnings Exact identifier application number: M017 RadiaGuard Advanced Radiation Relief LIDOCAINE HYDROCHLORIDE SMOOTH SIDE, INC 21205087-5a2e-41a5-be40-30cba2895408 2023-11-06 Warnings Exact identifier application number: M017 BLUE SPRING Foot and Leg Comfort MENTHOL ACA MANAGEMENT LLC 5f52218d-eea4-4640-b820-84c077ab98ba 2023-11-06 Warnings Exact identifier application number: M017 EMU THERAPY Red Hot Pepper Pain Relief Cream MENTHOL, CAPSAICIN ACA MANAGEMENT LLC 36293885-b2dd-4fba-9748-35a3c9e05078 2023-11-06 Warnings Exact identifier application number: M017 ROPANA Pain Relief Cream HISTAMINE DIHYDROCHLORIDE FUSION PAIN SOLUTIONS LLC e0342aa3-ca80-40b7-bec6-1b33c4db398b 2023-11-06 Warnings Exact identifier application number: M017 EMU THERAPY Cool Menthol Therapy Pain Relief Cream MENTHOL ACA MANAGEMENT LLC 16894346-3513-41b1-b09f-72d84edcc4ac 2023-11-06 Warnings Exact identifier application number: M017 SKINS DELAY Climax Control Lidocaine LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 0db91010-12f7-4f20-b96c-432915720d5a 2023-11-06 Warnings Exact identifier application number: M017 POWERECT Lidocaine Male Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 42e0c40f-1efd-45ef-815d-53d193d720eb 2023-11-06 Warnings Exact identifier application number: M017 ARTHRO LIFE Instant Pain Relief Cream MENTHOL BIOBEST SERVICES LLC 66eb1a78-6861-4693-b68e-bd4a664fc075 2023-11-06 Warnings Exact identifier application number: M017 PARACTIN QuantumActiv Pain Relief Cream MENTHOL NHR SCIENCE CORP ae2f89cf-120c-4c6f-9e81-4560e6fa0373 2023-11-06 Warnings Exact identifier application number: M017 FISICO Arthrozene Pain Cream MENTHOL FISICO INC. d02c4349-78dd-4672-9582-50124ea9f1e1 2023-11-06 Warnings Exact identifier application number: M017 BRONSON SOOTHE Pain Relief CAPSAICIN BRONSON NUTRITIONALS, LLC cedf8f43-b9a3-4a06-b3a1-cf82668541f8 2023-11-06 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