K2 Cold Therapy

Product NDC: 54633-201
11-digit product format: 546330201
Labeler code: 54633
Product ID: 54633-201_c0cea7f6-24bb-4efc-9e67-37835acf6b03
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: LIQUID
Route: TOPICAL
Labeler: The Podiatree Co
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-05-06
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 10 g/100mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54633-201		I	Inactivated by FDA		2026-10-12
excluded package	package	54633-201	54633-201-13	I	Inactivated by FDA		2026-10-12

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 · 44 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54633-201-13	`d630ba8d3edf…`	`732f749b63fb…`
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	54633-201-13	`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	54633-201-13	`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	54633-201-13	`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	54633-201-13	`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	54633-201-13	`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	54633-201-13	`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	54633-201-13	`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	54633-201-13	`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	54633-201-13	`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	54633-201-13	`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	54633-201-13	`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	54633-201-13	`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	54633-201-13	`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	54633-201-13	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54633-201-13	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54633-201-13	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54633-201-13	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54633-201-13	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54633-201-13	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54633-201-13	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	54633-201-13	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54633-201-13	2019-11-27	C162847	48780-1	9855e2a2-3675-60a7-e053-dbdaa90a05bd	6ff293e6-951b-4b8d-8f62-9d7985f340b7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54633-201-13	K2 Cold Therapy	88.72 mL in 1 BOTTLE	LIQUID	88.72		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
EUCALYPTUS GLOBULUS LEAF	INACTIVE INGREDIENT	S546YLW6E6	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
ROSMARINUS OFFICINALIS WHOLE	INACTIVE INGREDIENT	EA3289138M	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
SIMMONDSIA CHINENSIS WHOLE	INACTIVE INGREDIENT	DFM16KFA82	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
STEARETH-2	INACTIVE INGREDIENT	V56DFE46J5	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
STEARETH-20	INACTIVE INGREDIENT	L0Q8IK9E08	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
UREA	INACTIVE INGREDIENT	8W8T17847W	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
VITIS VINIFERA SEED	INACTIVE INGREDIENT	C34U15ICXA	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54633-201	K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]	1	Legacy NDC, 1 package rows	20140506_6ff293e6-951b-4b8d-8f62-9d7985f340b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
259249	menthol 10 % Topical Gel	PSN	6ff293e6-951b-4b8d-8f62-9d7985f340b7	1
259249	menthol 0.1 MG/MG Topical Gel	SCD	6ff293e6-951b-4b8d-8f62-9d7985f340b7	1
259249	menthol 10 % Topical Gel	SY	6ff293e6-951b-4b8d-8f62-9d7985f340b7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54633-201-13	54633020113	88.72 mL in 1 BOTTLE	88.72 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
K2 Cold Therapy - The Podiatree Co \| EMS Contract Packaging	The Podiatree Co \| EMS Contract Packaging	2014-04-18	HUMAN OTC DRUG LABEL	1