Cold Therapy

Product NDC: 68678-011
11-digit product format: 686780011
Labeler code: 68678
Product ID: 68678-011_3dd632d6-58a1-ab21-e063-6394a90a850c
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68678-011		D	Discontinued by firm	2026-10-16
excluded product	product	68678-011		D	Discontinued by firm	2026-10-16
excluded package	package	68678-011	68678-011-90	D	Discontinued by firm	2026-10-16
excluded package	package	68678-011	68678-011-04	D	Discontinued by firm	2026-10-16
excluded package	package	68678-011	68678-011-16	D	Discontinued by firm	2026-10-16
excluded package	package	68678-011	68678-011-32	D	Discontinued by firm	2026-10-16

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 4 · 188 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68678-011-16	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68678-011-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68678-011-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68678-011-32	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68678-011-99	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68678-011-16	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68678-011-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68678-011-90	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68678-011-17	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68678-011-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68678-011-32	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68678-011-99	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68678-011-16	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68678-011-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68678-011-90	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68678-011-17	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68678-011-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68678-011-32	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68678-011-99	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68678-011-16	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68678-011-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68678-011-90	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68678-011-17	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68678-011-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68678-011-32	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68678-011-99	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68678-011-16	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68678-011-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68678-011-90	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68678-011-17	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68678-011-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68678-011-32	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68678-011-99	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68678-011-16	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68678-011-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68678-011-90	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68678-011-17	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68678-011-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68678-011-32	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68678-011-99	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`

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
259249	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
90334420-5f81-4284-9a57-42e134ce362f	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
68678-011-05	2025-09-02	9d75b9d0-d807-f424-e053-dadaa90a57ce	Cold Therapy Menthol Gel
68678-011-17	2025-09-02	9d75b9d0-d807-f424-e053-dadaa90a57ce	Cold Therapy Menthol Gel
68678-011-99	2025-09-02	9d75b9d0-d807-f424-e053-dadaa90a57ce	Cold Therapy Menthol Gel
68678-011-05	2024-01-30	9d75b9d0-d807-f424-e053-dadaa90a57ce	Cold Therapy Menthol Gel
68678-011-17	2024-01-30	9d75b9d0-d807-f424-e053-dadaa90a57ce	Cold Therapy Menthol Gel
68678-011-99	2024-01-30	9d75b9d0-d807-f424-e053-dadaa90a57ce	Cold Therapy Menthol Gel
68678-011-04	2022-05-04	9d75b9cf-d13c-f424-e053-dadaa90a57ce	Cryoderm Cold Therapy Spray
68678-011-16	2022-05-04	9d75b9cf-d13c-f424-e053-dadaa90a57ce	Cryoderm Cold Therapy Spray
68678-011-32	2022-05-04	9d75b9cf-d13c-f424-e053-dadaa90a57ce	Cryoderm Cold Therapy Spray
68678-011-90	2022-05-04	9d75b9d0-80f2-f424-e053-dadaa90a57ce	Cryoderm Cold Therapy Roll On
68678-011-05	2022-05-03	9d75b9d0-d807-f424-e053-dadaa90a57ce	Cold Therapy Menthol Gel
68678-011-17	2022-05-03	9d75b9d0-d807-f424-e053-dadaa90a57ce	Cold Therapy Menthol Gel
68678-011-99	2022-05-03	9d75b9d0-d807-f424-e053-dadaa90a57ce	Cold Therapy Menthol Gel
68678-011-04	2020-01-31	9d75b9cf-d13c-f424-e053-dadaa90a57ce	Cryoderm Cold Therapy Spray
68678-011-05	2020-01-31	9d75b9d0-d807-f424-e053-dadaa90a57ce	Cold Therapy Menthol Gel
68678-011-16	2020-01-31	9d75b9cf-d13c-f424-e053-dadaa90a57ce	Cryoderm Cold Therapy Spray
68678-011-17	2020-01-31	9d75b9d0-d807-f424-e053-dadaa90a57ce	Cold Therapy Menthol Gel
68678-011-32	2020-01-31	9d75b9cf-d13c-f424-e053-dadaa90a57ce	Cryoderm Cold Therapy Spray
68678-011-90	2020-01-31	9d75b9d0-80f2-f424-e053-dadaa90a57ce	Cryoderm Cold Therapy Roll On
68678-011-99	2020-01-31	9d75b9d0-d807-f424-e053-dadaa90a57ce	Cold Therapy Menthol Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68678-011-05	Cold Therapy	126 mL in 1 BOTTLE, DISPENSING	GEL	126	4
68678-011-17	Cold Therapy	504 mL in 1 BOTTLE, DISPENSING	GEL	504	4
68678-011-99	Cold Therapy	3 mL in 1 PACKET	GEL	3	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68678-011	COLD THERAPY (MENTHOL) GEL [AHC VENTURES CORP DBA CRYODERM]	3	Current NDC, Legacy NDC, 3 package rows	20220504_90334420-5f81-4284-9a57-42e134ce362f.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 3 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calamine Plus	CALAMINE, PRAMOXINE HYDROCHLORIDE	Kroger Company	44fdd5a4-3cac-15e5-e063-6294a90adb52	2026-08-26	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief	LIDOCAINE	Cardinal Health, 110 dba LEADER	025d508b-ec4f-466c-b3e8-ba9b18d07b46	2026-08-26	Warnings	Exact identifier application number: M017
Inknows Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	59eb9c12-9e00-0171-e063-6394a90a8342	2026-08-25	Warnings	Exact identifier application number: M017
Lidomar	LIDOMAR	Oncora Pharma, LLC	215bfdca-60bf-480b-b02e-902de52fe5e8	2026-08-25	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	5f87d7fb-f258-48b0-8b60-1055e22ebd71	2026-08-25	Warnings	Exact identifier application number: M017
HEEL PAIN RELIEF ROLL-ON	LIDOCAINE AND MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	59c7e13f-b9ea-023a-e063-6294a90a79e0	2026-08-24	Warnings	Exact identifier application number: M017
KNEE PAIN RELIEF ROLL-ON	LIDOCAINE AND MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	59c8b33a-7d4f-2c6e-e063-6394a90a7929	2026-08-24	Warnings	Exact identifier application number: M017
Bovonte Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5958cc29-c449-56a7-e063-6394a90a960b	2026-08-24	Warnings	Exact identifier application number: M017
HUSTLE BUTTER NUMBING	LIDOCAINE HYDROCHLORIDE	H.B.D. D.I.S.T. INC.	d7dfb312-6c80-4a2d-b8b2-d9891cb0b74e	2026-08-24	Warnings	Exact identifier application number: M017
JELVOXA NECK PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	59a3d60a-26b5-e6a6-e063-6294a90a42bd	2026-08-22	Warnings	Exact identifier application number: M017
JELVOXA DMSO	CAMPHOR CAPSAICIN MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	59a43e2c-d258-34b5-e063-6394a90a09bf	2026-08-22	Warnings	Exact identifier application number: M017
Capsaicin 0.035 Percent	CAPSAICIN	Preferred Pharmaceuticals Inc.	0fabc025-4208-45f5-b3c2-543ae3a2df41	2026-08-21	Warnings	Exact identifier application number: M017
Claravie	HYDROCORTISONE ACETATE	Gentell LLC	598d224b-d12e-89bf-e063-6394a90a84dc	2026-08-21	Warnings	Exact identifier application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING	MENTHOL, CAMPHOR	Worldwide Cosmetics, Inc	3b8c2419-7a78-2731-e054-00144ff8d46c	2026-08-21	Warnings	Exact identifier application number: M017
PARCHE FRIO	METHYL SALICYLATE, MENTHOL, AND CAMPHOR PATCH	DW SUPPORT LLC	5970a6f7-b273-9bb1-e063-6394a90afc79	2026-08-21	Warnings	Exact identifier application number: M017
Enokon Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	5976e667-e506-1d11-e063-6394a90a6809	2026-08-20	Warnings	Exact identifier application number: M017
MQUPIN TIGER Patch	TIGER PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	5977cbb5-94c7-cb24-e063-6294a90a2e07	2026-08-20	Warnings	Exact identifier application number: M017
MQUPIN Nicotine Patches	NICOTINE PATCHES	Zhengzhou Miaoqi Medical Technology Co., Ltd.	5978258a-549e-50e6-e063-6394a90a3d86	2026-08-20	Warnings	Exact identifier application number: M017
Claravie	CAMPHOR	Gentell LLC	5978bdab-5359-be9a-e063-6394a90a5a32	2026-08-20	Warnings	Exact identifier application number: M017
Rugby PAIN RELIEF PATCHES	LIDOCAINE	RUGBY LABORATORIES	b34e40c8-a257-46cf-9399-f55df9b4102d	2026-08-20	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
259249	menthol 10 % Topical Gel	PSN	90334420-5f81-4284-9a57-42e134ce362f	4
259249	menthol 0.1 MG/MG Topical Gel	SCD	90334420-5f81-4284-9a57-42e134ce362f	4
259249	menthol 10 % Topical Gel	SY	90334420-5f81-4284-9a57-42e134ce362f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68678-011-05	68678001105	126 mL in 1 BOTTLE, DISPENSING (68678-011-05)	126 ml	2016-01-01	0000-00-00	No	No	Current
68678-011-17	68678001117	504 mL in 1 BOTTLE, DISPENSING (68678-011-17)	504 ml	2016-01-01	0000-00-00	No	No	Current
68678-011-99	68678001199	3 mL in 1 PACKET (68678-011-99)	3 ml	2016-01-01	0000-00-00	No	No	Current