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 87 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On	LIDOCAINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c4	2025-07-11	Warnings	Exact identifier application number: M017
Antibiotic Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	TARGET Corporation	6fba5890-f48f-4302-a8ac-5087a6e03bd5	2025-07-11	Warnings	Exact identifier application number: M017
TopCare Antibiotic Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	55dc4025-f07f-41b2-8b18-6a11ee04b5cc	2025-07-11	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	309d9be0-e367-429a-a1fa-ab7855477c8a	2025-07-10	Warnings	Exact identifier application number: M017
Bengay Vanishing Scent	MENTHOL, UNSPECIFIED FORM	Kenvue Brands LLC	6cc3294b-3b0f-44d0-af71-61db1022d269	2025-07-10	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	Quality Choice	ce544a7c-8dc6-4e63-b499-d8a4e0ec48c3	2025-07-10	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE ACETATE	Walgreen Company	bff322f1-59c3-41e0-8685-fcfe52bf4b42	2025-07-10	Warnings	Exact identifier application number: M017
CVS Cortisone	HYDROCORTISONE	CVS Pharmacy	87631be8-94b8-4718-858d-d2f30e636cce	2025-07-10	Warnings	Exact identifier application number: M017
TopCare Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	Topco Associates LLC	c40e8e1d-d6d7-4880-99d3-011b97a5e4f3	2025-07-10	Warnings	Exact identifier application number: M017
Live Better Hydrocortisone with Aloe	HYDROCORTISONE	The Great Atlantic & Pacific Tea Company	044e6ee2-98a6-4802-b33d-78b8551356c4	2025-07-10	Warnings	Exact identifier application number: M017
Rocainol TOPICAL ANALGESIC	METHYL SALICYLATE, MENTHOL	Compania Internacional de Comercio, S.A.P.I de C.V.	827ec7b2-3d87-47e0-a47a-966b25732c32	2025-07-10	Warnings	Exact identifier application number: M017
NumbR-X	LIDOCAINE HCL	Prodigy Media Inc	16329ab6-4a33-4c38-85e0-5aad9c75d61d	2025-07-10	Warnings	Exact identifier application number: M017
Dr Lido	LIDOCAINE HCL	Prodigy Media Inc	da0938f0-00e7-4502-8721-d64c71f594fc	2025-07-10	Warnings	Exact identifier application number: M017
Pain Relief Patch	CAMPHOR, METHYL SALICYLATE, MENTHOL	CDMA, Inc.	da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b	2025-07-09	Warnings	Exact identifier application number: M017
ORTHOGEL Menthol 3.5%	MENTHOL	LiquidCapsule Manufacturing LLC	4fd4b7ac-1971-4abe-8fbb-74ab69e12061	2025-07-09	Warnings	Exact identifier application number: M017
Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	AmerisourceBergen	f36acdb8-a526-4bb7-a557-e1dcbbc1cf45	2025-07-08	Warnings	Exact identifier application number: M017
Good Neighbor Pharmacy Hydrocortisone with Aloe	HYDROCORTISONE	AmerisourceBergen	0c544792-63d9-400c-9888-207c44fdc75e	2025-07-08	Warnings	Exact identifier application number: M017
Good Neighbor Pharmacy Hydrocortisone	HYDROCORTISONE	AmerisourceBergen	58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf	2025-07-08	Warnings	Exact identifier application number: M017
Publix Hydro	HYDROCORTISONE	Publix Super Markets Inc	29296b0f-0eed-4bb9-8727-c25c2bcf9fd6	2025-07-08	Warnings	Exact identifier application number: M017
Publix hydro plus	HYDROCORTISONE	Publix Super Markets Inc	a00d82c1-6b09-424a-be78-2603eee3fb9d	2025-07-08	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