Hot/Cold Medicated Patch

Product NDC: 67777-201
11-digit product format: 677770201
Labeler code: 67777
Product ID: 67777-201_304db1ab-acd9-43d5-e063-6294a90aeec2
Type: HUMAN OTC DRUG
Nonproprietary name: Hot Cold Patch
Dosage form: PATCH
Route: TOPICAL
Labeler: Dynarex
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-12-13
Substance: MENTHOL
Active strength: 285 mg/5700mg
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Hot/Cold Medicated Patch
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	285 mg/5700mg

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
420222	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
999881b3-287e-d975-e053-2995a90a87e3	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67777-201-08	Hot/Cold Medicated Patch	36 in 1 CASE	PATCH	36	5
67777-201-09	Hot/Cold Medicated Patch	285 mg in 1 PATCH	PATCH	285	5
67777-201-09	Hot/Cold Medicated Patch	3 in 1 BAG	PATCH	3	5
67777-201-10	Hot/Cold Medicated Patch	36 in 1 CASE	PATCH	36	5
67777-201-11	Hot/Cold Medicated Patch	5 in 1 BOX	PATCH	5	5
67777-201-11	Hot/Cold Medicated Patch	285 mg in 1 PATCH	PATCH	285	5
67777-201-20	Hot/Cold Medicated Patch	36 in 1 CASE	PATCH	36	5
67777-201-21	Hot/Cold Medicated Patch	285 mg in 1 PATCH	PATCH	285	5
67777-201-21	Hot/Cold Medicated Patch	5 in 1 BOX	PATCH	5	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67777-201	HOT/COLD MEDICATED PATCH (HOT COLD PATCH) PATCH [DYNAREX]	5	Current NDC, Legacy NDC, 9 package rows	20250321_999881b3-287e-d975-e053-2995a90a87e3.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 142 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Poli-A	HYDROCORTISONE ACETATE	Sato Pharmaceutical Co., Ltd.	e27a3840-d9de-4bd0-ad75-8a151bd12b83	2023-11-28	Warnings	Exact identifier application number: M017
Sheffield Arthritis and Muscle Pain Relief	CAPSICUM OLEORESIN	Sheffield Pharmaceuticals LLC	724b9870-e86a-4087-ba78-8c944ce3baa6	2023-11-28	Warnings	Exact identifier application number: M017
Dr Sheffield Muscle Rub Cream	MUSCLE RUB CREAM	Sheffield Pharmaceuticals LLC	60d1d826-a53e-42e5-bc30-1b2c2690445b	2023-11-28	Warnings	Exact identifier application number: M017
Thera Plus Cold Therapy Pain Relieving Menthol	MENTHOL	Fourstar Group USA, Inc.	0a462c91-5300-e282-e063-6394a90a4cc2	2023-11-27	Warnings	Exact identifier application number: M017
UtaSpray	MENTHOL AND METHYL SALICYLATE	Big 5 Nutrition LLC	c641ab11-cd00-4e23-ace7-8178739084f0	2023-11-21	Warnings	Exact identifier application number: M017
Top Medicated Oil	CAMPHOR, MENTHOL, METHYL SALICYLATE	Big 5 Nutrition LLC	b2f0d1e1-7d03-434e-be39-9f980459690c	2023-11-21	Warnings	Exact identifier application number: M017
BT Pain Relief Balm	METHYL SALICYLATE, MENTHOL, CAMPHOR	Big 5 Nutrition LLC	50112419-c934-4d3a-9ea6-9b089f516a6d	2023-11-21	Warnings	Exact identifier application number: M017
BT Pain Relief	MENTHOL, METHYL SALICYLATE	Big 5 Nutrition LLC	91324910-27cf-424f-9e9b-6173f2d7acbf	2023-11-21	Warnings	Exact identifier application number: M017
Dit Da Shui	MENTHOL AND METHYL SALICYLATE	Big 5 Nutrition LLC	5d45cb48-3e88-4d58-81d2-6f88d7a82134	2023-11-20	Warnings	Exact identifier application number: M017
Herbal Balm	METHYL SALICYLATE, MENTHOL AND	Big 5 Nutrition LLC	09b3b86d-3434-428b-b0a8-e8dfd7c0b52a	2023-11-20	Warnings	Exact identifier application number: M017
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	b505769e-9c46-3cf3-e053-2a95a90a4df9	2023-11-17	Warnings	Exact identifier application number: M017
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	d6523993-d781-cdbc-e053-2a95a90af191	2023-11-17	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	4d91baf3-9655-4786-93b8-aa0d93fe0bf9	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE LEG CRAMP	MENTHOL	KOBAYASHI Healthcare International, Inc.	7ef03298-6623-4cf4-b21f-74b2ffc11c6e	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	436e8578-b609-4b45-8f84-0d111140fda6	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL	KOBAYASHI Healthcare International, Inc.	08dcfa78-7332-4f19-90d7-fdd7d446848a	2023-11-16	Warnings	Exact identifier application number: M017
Totally Fun After Sun	LIDOCAINE HCL	MJ Products Association, LLC	965a2a29-914c-4ad0-b25f-5df3c30da393	2023-11-15	Warnings	Exact identifier application number: M017
Universal Ice Cold Analgesic	MENTHOL	Universal Distribution Center LLC	4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f	2023-11-15	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	b44beac3-1d20-434f-9a79-4fab1ac68791	2023-11-15	Warnings	Exact identifier application number: M017
Universal Ice Cold Analgesic	MENTHOL	Universal Distribution Center LLC	79ad55eb-b59d-4bb8-88e3-3b51e10a7f28	2023-11-15	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
420222	menthol 5 % Medicated Patch	PSN	999881b3-287e-d975-e053-2995a90a87e3	5
420222	menthol 0.05 MG/MG Medicated Patch	SCD	999881b3-287e-d975-e053-2995a90a87e3	5
420222	menthol 5 % Medicated Patch	SY	999881b3-287e-d975-e053-2995a90a87e3	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67777-201-08	67777020108	36 BAG in 1 CASE (67777-201-08) / 3 PATCH in 1 BAG (67777-201-09) / 285 mg in 1 PATCH	36 bag	2019-12-13		No	No	Current
67777-201-09	67777020109	285 mg in 1 PATCH	285 mg					Historical
67777-201-10	67777020110	36 BOX in 1 CASE (67777-201-10) / 5 PATCH in 1 BOX (67777-201-11) / 285 mg in 1 PATCH	36 box	2019-12-13	0000-00-00	No	No	Current
67777-201-11	67777020111	5 in 1 BOX						Historical
67777-201-20	67777020120	36 BOX in 1 CASE (67777-201-20) / 5 PATCH in 1 BOX (67777-201-21) / 285 mg in 1 PATCH	36 box	2019-12-13	0000-00-00	No	No	Current
67777-201-21	67777020121	285 mg in 1 PATCH	285 mg					Historical