Coralite Cold and Hot

Product NDC: 65923-153
11-digit product format: 659230153
Labeler code: 65923
Product ID: 65923-153_d140c61b-a2ac-46b7-83e6-cfb4c348089a
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: PATCH
Route: TOPICAL
Labeler: United Exchange Corp.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-12-16
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 5 mg/g
NDC exclude flag: No
Listing certified through: 2020-12-31
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	65923-153		I	Inactivated by FDA		2026-10-12
excluded package	package	65923-153	65923-153-02	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 · 36 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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`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	65923-153-02	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65923-153-02	2022-01-28	C162847	48780-1	d6a99b39-e9a4-a426-e053-dadaa90af4c2	d7b8cf68-a3d5-4dc0-b90d-30cf9f3d8160

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65923-153-02	Coralite Cold and Hot	2 in 1 POUCH	PATCH	2		4
65923-153-02	Coralite Cold and Hot	1 g in 1 PATCH	PATCH	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	CORALITE COLD AND HOT (MENTHOL) PATCH [UNITED EXCHANGE CORP.]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	CORALITE COLD AND HOT (MENTHOL) PATCH [UNITED EXCHANGE CORP.]	2
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	CORALITE COLD AND HOT (MENTHOL) PATCH [UNITED EXCHANGE CORP.]	2
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	CORALITE COLD AND HOT (MENTHOL) PATCH [UNITED EXCHANGE CORP.]	2
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	CORALITE COLD AND HOT (MENTHOL) PATCH [UNITED EXCHANGE CORP.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CORALITE COLD AND HOT (MENTHOL) PATCH [UNITED EXCHANGE CORP.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CORALITE COLD AND HOT (MENTHOL) PATCH [UNITED EXCHANGE CORP.]	2
POLYACRYLIC ACID (8000 MW)	INACTIVE INGREDIENT	73861X4K5F	CORALITE COLD AND HOT (MENTHOL) PATCH [UNITED EXCHANGE CORP.]	2
PROPANEDIOL	INACTIVE INGREDIENT	5965N8W85T	CORALITE COLD AND HOT (MENTHOL) PATCH [UNITED EXCHANGE CORP.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CORALITE COLD AND HOT (MENTHOL) PATCH [UNITED EXCHANGE CORP.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CORALITE COLD AND HOT (MENTHOL) PATCH [UNITED EXCHANGE CORP.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65923-153	CORALITE COLD AND HOT (MENTHOL) PATCH [UNITED EXCHANGE CORP.]	4	Legacy NDC, 2 package rows	20170721_d7b8cf68-a3d5-4dc0-b90d-30cf9f3d8160.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
420222	menthol 5 % Medicated Patch	PSN	d7b8cf68-a3d5-4dc0-b90d-30cf9f3d8160	4
420222	menthol 0.05 MG/MG Medicated Patch	SCD	d7b8cf68-a3d5-4dc0-b90d-30cf9f3d8160	4
420222	menthol 5 % Medicated Patch	SY	d7b8cf68-a3d5-4dc0-b90d-30cf9f3d8160	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65923-153-02	65923015302	2 PATCH in 1 POUCH (65923-153-02) > 1 g in 1 PATCH	2 patch	2017-07-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Coralite Cold and Hot - United Exchange Corp.	United Exchange Corp.	2017-07-20	HUMAN OTC DRUG LABEL	4