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 5 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RELIBONEOintment	TOPICAL ANALGESICOINTMENT	Guangdong Jiaoyu Biotechnology Co., Ltd	58ddaaf6-18ec-8c5b-e063-6294a90a2828	2026-08-12	Warnings	Exact identifier application number: M017
Capsaicin Cream	CAPSAICIN	Trifecta Pharmaceuticals USA LLC	58de3a29-2bec-6e44-e063-6394a90a9c1a	2026-08-12	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	Amazon.com Services LLC	f40b4223-e81f-4cd0-bc9b-d3d33ce8cce5	2026-08-12	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MUSCLE RUB	ALLIED TRADE LINK LLC	11d33e60-8c64-4316-a29a-d17e3e6e4a28	2026-08-11	Warnings	Exact identifier application number: M017
Gee Gason	MALE GENITAL DESENSITIZER	Mon Gars Boutique Inc	58c75e5c-b801-017f-e063-6394a90a1c75	2026-08-11	Warnings	Exact identifier application number: M017
Capsaicin Cream	CAPSAICIN	Trifecta Pharmaceuticals USA LLC	58c84330-15bf-c397-e063-6394a90aba05	2026-08-11	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	TARGET Corporation	4a140b9a-0e3c-4b50-b9c0-9e72616bb7d5	2026-08-11	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	CVS Pharmacy	0e988da1-1904-431d-a152-bdb2aacc8e16	2026-08-11	Warnings	Exact identifier application number: M017
Medicated BODY	MENTHOL	CVS Pharmacy, Inc.	a0f61498-69c8-4ce0-bbd7-3a807f192d36	2026-08-11	Warnings	Exact identifier application number: M017
Muscle Move	MENTHOL	Saje Natural Wellness Inc.	526d3305-4cf8-2fc5-e063-6394a90ad53b	2026-08-10	Warnings	Exact identifier application number: M017
Relieve and Relax Pain Relieving	CAMPHOR (SYNTHETIC), MENTHOL	MAC Innovations, LLC	c0528c36-d322-8110-e053-2995a90add6c	2026-08-08	Warnings	Exact identifier application number: M017
CVS Pain Relief	MENTHOL	CVS Pharmacy	4aa629f5-8b8f-cc67-e063-6394a90a019f	2026-08-07	Warnings	Exact identifier application number: M017
Instant Cooling Itch Relief	HYDROCORTISONE	CVS Pharmacy	46545d04-5958-d136-e063-6394a90a3462	2026-08-07	Warnings	Exact identifier application number: M017
CVS Itch Relief	PRAMOXINE HYDROCHLORIDE, ZINC ACETATE	CVS Pharmacy	46921bea-fcbe-94d6-e063-6394a90a726b	2026-08-07	Warnings	Exact identifier application number: M017
CVS Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	CVS Pharmacy	524605f9-8b04-b600-e063-6394a90a4a02	2026-08-07	Warnings	Exact identifier application number: M017
Lidonex	LIDOCAINE HCL, MENTHOL	Aldama Pharmaceuticals, Inc	365cf19c-70e0-c4e9-e063-6294a90ac428	2026-08-07	Warnings	Exact identifier application number: M017
Blaster Pain Relief Stick	MENTHOL, METHYL SALICYLATE, CAMPHOR	Kalahari Rose, LLC	587d660a-5f80-de5a-e063-6394a90aa287	2026-08-07	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Cardinal Health, 110 dba Leader	3ed7b8a1-012f-459d-878c-813b93d4673c	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M017
Gel Cooling Pain Relief	MENTHOL	The Kroger Co.	6fb0acc8-8dab-452c-b09e-de97306e1c32	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M017
Lidocaine Tattoo Wipe	LIDOCAINE HYDROCHLORIDE	MD Tattoo Company	369c1d16-597c-e1dc-e063-6394a90a3104	2026-08-06	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