Cold Therapy

Product NDC: 68678-013
11-digit product format: 686780013
Labeler code: 68678
Product ID: 68678-013_3dd5fb17-c856-952b-e063-6294a90a16b2
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

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 · 28 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	68678-013-90	`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	68678-013-90	`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	68678-013-90	`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	68678-013-90	`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	68678-013-90	`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	68678-013-90	`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	68678-013-90	`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	68678-013-90	`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	68678-013-90	`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	68678-013-90	`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	68678-013-90	`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	68678-013-90	`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	68678-013-90	`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	68678-013-90	`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
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
52fff03e-eba2-4604-a71c-2522468f627b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68678-013-90	2025-09-02	C162847	48780-1	9d75b9d0-80f2-f424-e053-dadaa90a57ce	Cryoderm Cold Therapy Roll On
68678-013-90	2024-01-30	C162847	48780-1	9d75b9d0-80f2-f424-e053-dadaa90a57ce	Cryoderm Cold Therapy Roll On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68678-013-90	Cold Therapy	95 mL in 1 BOTTLE, DISPENSING	GEL	95		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68678-013	COLD THERAPY (MENTHOL) GEL [AHC VENTURES CORP DBA CRYODERM]	3	Current NDC, Legacy NDC, 1 package rows	20220505_52fff03e-eba2-4604-a71c-2522468f627b.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 130 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LidoReal Patch	LIDOCAINE AND MENTHOL	FORREAL PHARMACEUTICALS LLC	19f1c037-b4b8-47b0-b0f9-036691c1d307	2024-07-05	Warnings	Exact identifier application number: M017
Lip Medex Lip Balm	PETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL	Blistex Inc.	988f97e8-a59f-4bc0-9d71-60607364a686	2024-07-01	Warnings	Exact identifier application number: M017
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM	MENTHOL	L'Oreal USA Products Inc	d580982f-dda6-4b03-bf84-342b9f2c6d93	2024-06-29	Warnings	Exact identifier application number: M017
Lip Medex Cherry	PETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORM	Blistex Inc.	fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af8	2024-06-28	Warnings	Exact identifier application number: M017
10% Methyl Salicylate Pain Relief Patch	10% METHYL SALICYLATE	Akron Coating & Adhesives	1be1f1ce-3238-a8ed-e063-6294a90a5aed	2024-06-27		Exact identifier application number: M017
Genuine First Aid Alcohol Cleansing Pad	BENZOCAINE, ALCOHOL	GFA Production (Xiamen) Co., Ltd.	c39c4d80-9718-459f-8ae4-ada043bba5b7	2024-06-26	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	1bd5cf69-9a08-5e2e-e063-6394a90a03cd	2024-06-26	Warnings	Exact identifier application number: M017
Solarcaine Burn Pain Relief 4oz	SOLARCAINE BURN PAIN RELIEF 4OZ	WellSpring Pharmaceutical Corporation	2c0389db-ceb2-422b-9575-bdb8fe649a1e	2024-06-26	Warnings	Exact identifier application number: M017
astonea	HYDROCORTISONE	ASTONEA LABS PRIVATE LIMITED	de09e859-c5fd-0cc5-e053-2a95a90a147e	2024-06-25	Warnings	Exact identifier application number: M017
HealthWise Pain Relief Lidocaine Patch	LIDOCAINE 4%	Veridian Healthcare	0190196d-5f78-042b-e063-6294a90a3714	2024-06-25	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	1bc1bf83-91ee-ec9d-e063-6394a90a3daf	2024-06-25	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On	MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	1bc2f688-d0c4-690e-e063-6294a90abc38	2024-06-25	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil	MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	1b9fdac0-9fb0-e669-e063-6394a90aece9	2024-06-24	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	Asclemed USA, Inc.	97d506bd-3215-4e2e-9914-af1c174dd4ab	2024-06-20	Warnings	Exact identifier application number: M017
ABREVA Rapid Pain Relief	GLYCERIN, LIDOCAINE	Haleon US Holdings LLC	65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d	2024-06-20	Warnings	Exact identifier application number: M017
Frankie Avalons ZERO PAIN Roll-On Pain Reliever	CAPSAICIN	WHY ENTERPRISES LLC	e32acb5f-5bc3-4228-b037-6315d080f556	2024-06-17	Warnings	Exact identifier application number: M017
PUREGEN LABS Pain Relief 4 Lidocaine	LIDOCAINE	Advanced Rx LLC	9dff40d8-8d7e-4629-bea5-987f5e68477d	2024-06-11	Warnings	Exact identifier application number: M017
SMOOTH GATOR Head-Ezz Analgesic	MENTHOL	Smooth Gator LLC	02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd	2024-06-10	Warnings	Exact identifier application number: M017
FIRST AID BURN	LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE	Epic Medical Supply Corp	bd1b1873-e900-45eb-96a0-28f782b5a7cd	2024-06-04	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Chain Drug Marketing Association Inc.	1c834ba0-86b6-8e61-e063-6394a90a192d	2024-06-04	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	52fff03e-eba2-4604-a71c-2522468f627b	4
259249	menthol 0.1 MG/MG Topical Gel	SCD	52fff03e-eba2-4604-a71c-2522468f627b	4
259249	menthol 10 % Topical Gel	SY	52fff03e-eba2-4604-a71c-2522468f627b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68678-013-90	68678001390	95 mL in 1 BOTTLE, DISPENSING (68678-013-90)	95 ml	2016-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cryoderm Cold Therapy Roll On	AHC VENTURES CORP DBA CRYODERM \| Vege Labs LLC.	2025-09-02	HUMAN OTC DRUG LABEL	4