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 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine 4% Patch	LIDOCAINE	Aldermed Inc.	57994923-20fc-9d9d-e063-6394a90a22c9	2026-07-27	Warnings	Exact identifier application number: M017
Lidocaine 4% Patch	LIDOCAINE	Aldermed Inc.	579a5012-837a-828b-e063-6294a90a4fb2	2026-07-27	Warnings	Exact identifier application number: M017
Original Pain Relief	TOPICAL ANALGESIC LOTION	Real Time Pain Relief Inc	579bd303-9a50-4d66-e063-6294a90a6141	2026-07-27	Warnings	Exact identifier application number: M017
Lidfix Pain Relief Patch Lidocaine	LIDOCAINE	HETERO HEALTHCARE LIMITED	2149f0e3-1983-4f02-929e-ecd20357f4bb	2026-07-27	Warnings	Exact identifier application number: M017
RectoProtect	LIDOCAINE	Akron Pharma Inc.	1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb	2026-07-27	Warnings	Exact identifier application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEF	MENTHOL	OWELL NATURAL 8 LLC	57a124b4-66c6-2474-e063-6294a90ab0d7	2026-07-27	Warnings	Exact identifier application number: M017
Icy Hot Performance Dry	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	8927570f-761b-4d83-8612-30077224fdb8	2026-07-27	Warnings	Exact identifier application number: M017
NUMBING	LIDOCAINE	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	578675e8-30e7-6986-e063-6394a90a8afe	2026-07-26	Warnings	Exact identifier application number: M017
Do Me Delay Cream	BENZOCAINE	Prodigy Media	53d5cd6b-96b8-9ba2-e063-6294a90a0d15	2026-07-24	Warnings	Exact identifier application number: M017
Bravado Labs Delay Cream	BENZOCAINE	Prodigy Media Inc	57269544-9cfb-4ff0-e063-6394a90adb02	2026-07-24	Warnings	Exact identifier application number: M017
Zytherial Lidocaine 4% Pain Relief Patch	LIDOCAINE 4% PAIN RELIEF PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56db5028-b631-7981-e063-6294a90ae395	2026-07-24	Warnings	Exact identifier application number: M017
AEROBURN	LIDOCAINE HYDROCHLORIDE	Aero Healthcare US LLC	f8fa72db-5f7a-4158-a2b3-f8bc0e12df9f	2026-07-24	Warnings	Exact identifier application number: M017
AEROSOOTHE	HYDROCORTISONE	Aero Healthcare US LLC	22b172a2-07e8-4ebb-b0a0-dfe4f25477fa	2026-07-24	Warnings	Exact identifier application number: M017
Lidocaine Plus Pain Relieving	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	CVS Pharmacy	49003aac-184c-ae33-e063-6294a90a29c0	2026-07-24	Warnings	Exact identifier application number: M017
Arlun Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5765fbf1-e835-a11e-e063-6394a90a5ac2	2026-07-24	Warnings	Exact identifier application number: M017
DERMFREE PAIN RELIEF	ARNICA MONTANA HPUS 7% PAIN RELIEF	Jiangxi Yudexi Pharmaceutical Co., LTD	4bb74112-c4e7-7988-e063-6394a90ae3f1	2026-07-24	Warnings	Exact identifier application number: M017
SERYNTH HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	4c667f3d-1238-2f02-e063-6394a90ab742	2026-07-24	Warnings	Exact identifier application number: M017
DERMFREE NUMBING	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4ca7222b-d754-9861-e063-6294a90a1b7b	2026-07-24	Warnings	Exact identifier application number: M017
REINREUDE BACK PAIN THERAPY	CAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPY	Jiangxi Yudexi Pharmaceutical Co., LTD	4ca7d0ca-6407-1fed-e063-6394a90aaccc	2026-07-24	Warnings	Exact identifier application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AID	NICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AID	Jiangxi Yudexi Pharmaceutical Co., LTD	4d5821f9-605e-5391-e063-6294a90afcd2	2026-07-24	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