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 135 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Capsaicin	CAPSAICIN	Rugby Laboratories	c5915c84-84a2-46f6-9f97-0d9873e9944a	2024-02-12	Warnings	Exact identifier application number: M017
Leader Ice Blue Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	952e56ea-5cbc-4078-bd01-5d3b6864a5ce	2024-02-09	Warnings	Exact identifier application number: M017
Leader Ultra Strength Muscle Rub Topical Analgesic	CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE	Cardinal Health, 110 dba LEADER	9d99a900-60e0-454c-98e0-2c63eb910cf1	2024-02-09	Warnings	Exact identifier application number: M017
Pain Relieving	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	28821ffa-a138-47b5-8857-beadf7a20d43	2024-02-08	Warnings	Exact identifier application number: M017
Menthol Camphor Cough Suppressant Topical Analgesic Rub	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	fd0ea70a-ef12-48b1-8d9d-cc5f6417f854	2024-02-08	Warnings	Exact identifier application number: M017
Pain Relieving Cooling	MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	3574d48a-b546-4ea7-b470-071bb328de64	2024-02-08	Warnings	Exact identifier application number: M017
Advil Targeted Relief	CAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATE	Haleon US Holdings LLC	16e6be21-7b43-443a-89ec-3bdf0ec0dfc1	2024-02-08	Warnings	Exact identifier application number: M017
POINT RELIEF COLD SPOT Pain Relieving	MENTHOL	FABRICATION ENTERPRISES	96f1d592-6cec-412e-a5fd-cf3c4f68644f	2024-02-07	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	1c5eb3b3-79b3-472a-ae36-ec6a7dc72925	2024-02-07	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	8eb3e7e2-26e5-430e-89aa-40a0367c637e	2024-02-07	Warnings	Exact identifier application number: M017
Nova Natura Topical Analgesic	CAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATE	SEYITLER KIMYA SANAYI ANONIM SIRKETI	abf00f73-f0b1-439e-85aa-bbce8a1ec920	2024-02-06	Warnings	Exact identifier application number: M017
Leader Burn Relief	LIDOCAINE	Cardinal Health	f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2	2024-02-06	Warnings	Exact identifier application number: M017
Pain Relieving Petro Carbo	PHENOL	J.R. Watkins, LLC.	050cf17d-3be7-45b9-8524-ad82af309a0e	2024-02-06	Warnings	Exact identifier application number: M017
White Cream	CAMPHOR (NATURAL) AND TURPENTINE OIL	J.R. Watkins, LLC.	e4de0734-59d5-478c-86ea-66fc2ba003e7	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving Roll-On	MENTHOL, UNSPECIFIED FORM	Safetec of America, Inc.	80118260-9c88-402d-9a90-ecfe62b4b54f	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving	MENTHOL, UNSPECIFIED FORM	Safetec of America, Inc.	df512ce6-ce1b-434d-9571-fb2e1d76e1d0	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving	MENTHOL	Safetec of America, Inc.	52ebf64d-095f-467e-bf51-dd8d33b58c7d	2024-02-05	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Safetec of America, Inc.	4f4c801b-d894-4fa3-b024-6ca41a5f2a95	2024-02-04	Warnings	Exact identifier application number: M017
Analgesic	MENTHOL	Safetec of America, Inc.	79e3b0e7-4ba5-4b9d-a980-5b6f18dba802	2024-02-04	Warnings	Exact identifier application number: M017
HAV EZ Penetrating Pain Relief	MENTHOL	PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC	70006efc-9cc8-4490-b28c-fcb23b1737c4	2024-02-01	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