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.

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	68678-012-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68678-012-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68678-012-04	`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	68678-012-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68678-012-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68678-012-04	`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	68678-012-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68678-012-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68678-012-04	`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	68678-012-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68678-012-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68678-012-04	`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	68678-012-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68678-012-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68678-012-04	`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	68678-012-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68678-012-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68678-012-04	`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	68678-012-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68678-012-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68678-012-04	`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	68678-012-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68678-012-32	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68678-012-04	`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	68678-012-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68678-012-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68678-012-04	`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	68678-012-16	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68678-012-32	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68678-012-04	`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	68678-012-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68678-012-32	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68678-012-04	`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	68678-012-16	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68678-012-32	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68678-012-04	`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	68678-012-16	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68678-012-32	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68678-012-04	`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	68678-012-16	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68678-012-32	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68678-012-04	`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
1371206	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
dd95c682-8ddf-43e7-a277-2fca6ec744cc	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68678-012-04	2025-09-02	Cryoderm Cold Therapy Spray
68678-012-16	2025-09-02	Cryoderm Cold Therapy Spray
68678-012-32	2025-09-02	Cryoderm Cold Therapy Spray
68678-012-04	2024-01-30	Cryoderm Cold Therapy Spray
68678-012-16	2024-01-30	Cryoderm Cold Therapy Spray
68678-012-32	2024-01-30	Cryoderm Cold Therapy Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 1 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JenGufun LIDOCAINE KNEE Patch	LIDOCAINE KNEE PATCH	Henan Kangdi Medical Devices Co., Ltd.	5b1d8508-b993-7a8d-e063-6294a90ae306	2026-09-10	Warnings	Exact identifier application number: M017
Wart Corn Remover	SALICYLIC ACID	HONG KONG FOREVER YOUNG TRADING CO., LIMITED	5b0cd6e0-f220-4ebd-e063-6294a90ade67	2026-09-09	Warnings	Exact identifier application number: M017
Magic Cream	PAIN RELIEVING OINTMENT	Jiangxi Baikang Medical Products Co., Ltd.	5b0f2515-47e9-603f-e063-6294a90af9d4	2026-09-09	Warnings	Exact identifier application number: M017
Burn Gel	LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	e9d3e9be-1036-fad0-e053-2a95a90a6efe	2026-09-09	Warnings	Exact identifier application number: M017
4% Lidocaine Pain Relief Patch	LIDOCAINE 4%	Guangxi Keyun E-commerce Co., Ltd.	5b197cd8-542f-38b4-e063-6294a90ad7d3	2026-09-09	Warnings	Exact identifier application number: M017
Pain Relieving Lidocaine Patch	LIDOCAINE	YYBA CORP	af8c84fd-224c-72b3-e053-2a95a90a9568	2026-09-07	Warnings	Exact identifier application number: M017
American Safety First Aid	LIDOCAINE HCL	Orazen Inc	ea2f776b-dfd0-6ce4-e053-2995a90af009	2026-09-07	Warnings	Exact identifier application number: M017
MEDI-FIRST Topical Analgesic	LIDOCAINE HCI	Ultra Distributors Inc	b6f288f7-9ae3-215e-e053-2a95a90aedf6	2026-09-07	Warnings	Exact identifier application number: M017
MEDI-FIRST	BENZALKONIUM CHLORIDE, LIDOCAINE	Orazen Inc	f508434f-5948-7134-e053-2a95a90a03d7	2026-09-05	Warnings	Exact identifier application number: M017
MEDI-FIRST	BENZALKONIUM CHLORIDE, LIDOCAINE	Orazen Inc	f522fb0b-3d86-b228-e053-2a95a90a55e9	2026-09-05	Warnings	Exact identifier application number: M017
SurviveX Anti-itch Cream	SURVIVEX HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	5a7a1141-d3b1-0ee8-e063-6294a90a16aa	2026-09-04	Warnings	Exact identifier application number: M017
NeuroNesic Pain Relieving Cream	CAPSAICIN	Blaine Labs Inc.	7107c13d-bf59-4c0a-84fe-725a9fca2691	2026-09-04	Warnings	Exact identifier application number: M017
Neoteric Diabetic Skin Care 1 oz.	DIMETHICONE	RNA PHARMA LLC	5a944486-9591-f583-e063-6394a90aa04b	2026-09-03	Warnings	Exact identifier application number: M017
Equate Menthol Pain Relieving	MENTHOL	Wal-Mart Stores Inc	d5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc	2026-09-03	Warnings	Exact identifier application number: M017
ZHI Technologies	LIDOCAINE, MENTHOL	ZHI Technologies, Inc.	6717e995-4d2d-49e8-8ecf-7c62557dfdef	2026-09-03	Warnings	Exact identifier application number: M017
Komxsum LIDOCAINE Cream	LIDOCAINE 4% CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5a9feae0-9be4-e736-e063-6294a90abe55	2026-09-03	Warnings	Exact identifier application number: M017
FREEZE EASE Roll-On	MENTHOL	Global America Group LLC	1869cc0d-a056-45de-aede-23b09b61ed12	2026-09-02	Warnings	Exact identifier application number: M017
Gaimoa Lidocaine Pain Relief Gel Patches	LIDOCAINE PAIN RELIEF GEL PATCHES	Henan Enokon Medical Instrument Co., Ltd.	5a68fe67-5c15-af9a-e063-6294a90a7ec1	2026-09-01	Warnings	Exact identifier application number: M017
CVS Cortisone Liquid	HYDROCORTISONE	CVS Pharmacy	42df45a9-d449-090a-e063-6394a90a9ee4	2026-09-01	Warnings	Exact identifier application number: M017
Ramedica Herbal Wonder Balm	CAMPHOR, MENTHOL	Ramedicare Sdn. Bhd.	cfb2ea0e-a1f6-4fdf-b866-346bbe78788f	2026-09-01	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1371206	menthol 1 % Topical Spray	PSN	dd95c682-8ddf-43e7-a277-2fca6ec744cc	5
1371206	menthol 10 MG/ML Topical Spray	SCD	dd95c682-8ddf-43e7-a277-2fca6ec744cc	5
1371206	menthol 1 % Topical Spray	SY	dd95c682-8ddf-43e7-a277-2fca6ec744cc	5

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