Extra Strength Pain Relief Therapy

Product NDC: 65923-703
11-digit product format: 659230703
Labeler code: 65923
Product ID: 65923-703_92b4d194-0024-0f9f-e053-2a95a90a4ad3
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: 2013-06-30
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 750 mg/1
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	65923-703		I	Inactivated by FDA		2026-10-15
excluded package	package	65923-703	65923-703-05	I	Inactivated by FDA		2026-10-15

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 · 30 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	65923-703-05	`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	65923-703-05	`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	65923-703-05	`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	65923-703-05	`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	65923-703-05	`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	65923-703-05	`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	65923-703-05	`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	65923-703-05	`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	65923-703-05	`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	65923-703-05	`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	65923-703-05	`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	65923-703-05	`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	65923-703-05	`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	65923-703-05	`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	65923-703-05	`1332a3947898…`	`d4bfe170f9cd…`

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
65923-703-05	2024-01-30	C162847	48780-1	1030e365-1ebb-111a-e063-dadaa90a10e2	7e0a710d-8611-43b6-ade2-446d7482ab62

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65923-703-05	Extra Strength Pain Relief Therapy	5 in 1 POUCH	PATCH	5		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
SODIUM POLYMETAPHOSPHATE	INACTIVE INGREDIENT	P1BM4ZH95L	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65923-703	EXTRA STRENGTH PAIN RELIEF THERAPY (MENTHOL) PATCH [UNITED EXCHANGE CORP]	3	Legacy NDC, 1 package rows	20190917_7e0a710d-8611-43b6-ade2-446d7482ab62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
420222	menthol 5 % Medicated Patch	PSN	7e0a710d-8611-43b6-ade2-446d7482ab62	3
420222	menthol 0.05 MG/MG Medicated Patch	SCD	7e0a710d-8611-43b6-ade2-446d7482ab62	3
420222	menthol 5 % Medicated Patch	SY	7e0a710d-8611-43b6-ade2-446d7482ab62	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65923-703-05	65923070305	5 PATCH in 1 POUCH (65923-703-05)	5 patch	2013-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Extra Strength Pain Relief Therapy - United Exchange Corp	United Exchange Corp	2019-09-16	HUMAN OTC DRUG LABEL	3