MEDISTIK DUAL HOT AND COLD

Product NDC: 50231-511
11-digit product format: 502310511
Labeler code: 50231
Product ID: 50231-511_3edd4cdd-70b2-80ee-e063-6294a90af4a0
Type: HUMAN OTC DRUG
Nonproprietary name: Methyl Salicylate, Menthol
Dosage form: SPRAY
Route: TOPICAL
Labeler: Natureteq Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-02-19
Substance: MENTHOL; METHYL SALICYLATE
Active strength: 10; 12 g/100mL; 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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	50231-511		E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50231-511	50231-511-11	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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: MEDISTIK DUAL HOT AND COLD
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	10 g/100mL
METHYL SALICYLATE	12 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
LAV5U5022Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1738566	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
ba5f4626-f077-4a28-8dcc-dacd50741ead	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50231-511-11	MEDISTIK DUAL HOT AND COLD	118 mL in 1 BOTTLE	SPRAY	118		17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50231-511	MEDISTIK DUAL HOT AND COLD (METHYL SALICYLATE, MENTHOL) SPRAY [NATURETEQ INC.]	16	Current NDC, Legacy NDC, 1 package rows	20250108_ba5f4626-f077-4a28-8dcc-dacd50741ead.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 79 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PAIN RELIEF PATCHES	LIDOCAINE	Amerisource Bergen	614f1e56-891f-4620-be10-0c075a1dbc3f	2025-09-11	Warnings	Exact identifier application number: M017
Industrial Itch and Pain Relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	R & R Lotion, Inc	236415fc-f923-4a82-b54a-ecaf666dd2e0	2025-09-11	Warnings	Exact identifier application number: M017
Eco Lips Menthol Medicated Lip Balm	MENTHOL	Eco Lips, Inc.	fc4c25d6-6109-dfd8-e053-6394a90a4e91	2025-09-10	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Encube Ethicals, Inc.	d6f5c0df-6262-4704-bb24-430f66bb2ca8	2025-09-09	Warnings	Exact identifier application number: M017
Blue-Emu Lidocaine Pain Relief Cream	LIDOCAINE CREAM 4%	Kingsway Pharmaceuticals dba NFI, LLC	592811f2-e21c-6a58-e053-2991aa0a69a9	2025-09-09	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	282ed5ef-8c2a-4092-9d99-1a7eee7a39e3	2025-09-09	Warnings	Exact identifier application number: M017
LubeLife Climax Control Delay	BENZOCAINE	CC Wellness LLC	e1a98e6d-0c24-75b8-e053-2a95a90ad136	2025-09-09	Warnings	Exact identifier application number: M017
Blue-Emu Maximum Pain Relief	TROLAMINE SALICYLATE	Kingsway Pharmaceuticals dba NFI, LLC	c863351a-951b-4f7c-a9c0-4289d702054a	2025-09-09	Warnings	Exact identifier application number: M017
Tiger Balm Neck and Shoulder Rub	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	02a65b25-78b2-4e29-9484-40e2228fb384	2025-09-09	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	e90df2e5-2ef4-47dd-bd74-be9cea6d9d85	2025-09-08	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	69d6645e-db3c-4dc0-a9a5-e2bc963e2f28	2025-09-08	Warnings	Exact identifier application number: M017
SupreH Arnica Bruise Cream	SUPREH ARNICA REMEDY PLUS BRUISE CREAM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3e41fc0e-54c3-2622-e063-6294a90a13c9	2025-09-07	Warnings	Exact identifier application number: M017
Menthol	MENTHOL	FlexiGo Inc	3607c326-6db0-a2cd-e063-6394a90a9eb6	2025-09-06	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYOTHERAPY MENTHOL Cream	PAIN RELIEF CRYOTHERAPY MENTHOL CREAM	Shenzhen Sam Technology Co., Ltd.	3e08cc87-2385-0838-e063-6394a90abf9b	2025-09-05	Warnings	Exact identifier application number: M017
TIDL CLINICAL CRYOTHERAPY MENTHOL Cream	CLINICAL CRYOTHERAPY MENTHOL CREAM	Shenzhen Sam Technology Co., Ltd.	3e090b98-1db7-4174-e063-6394a90aa539	2025-09-05	Warnings	Exact identifier application number: M017
ALCEMISTE	LIDOCAINE HCL	Price Team Ventures, LLC	4383faaa-49cf-47b7-83a6-c2a94b6ff9b5	2025-09-05	Warnings	Exact identifier application number: M017
Lansinoh Pain Relieving	LIDOCAINE HCL	Lansinoh Laboratories Inc	b7cf1fdb-946d-a4e8-e053-2995a90a26a8	2025-09-05	Warnings	Exact identifier application number: M017
Sumifun PLANTAR RELIEF ROLL -ON	4% LIDOCAINE, 1% MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	3c9ee60b-548a-979f-e063-6394a90a70b0	2025-09-03	Warnings	Exact identifier application number: M017
Meijer Capsaicin Heat Patch	CAPSAICIN	Meijer Distribution	3c465557-0a4f-fb72-e063-6294a90a1ef2	2025-09-02	Warnings	Exact identifier application number: M017
Cold Therapy	MENTHOL	AHC Ventures Corp DBA Cryoderm	dd95c682-8ddf-43e7-a277-2fca6ec744cc	2025-09-02	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1738566	menthol 10 % / methyl salicylate 12 % Topical Spray	PSN	ba5f4626-f077-4a28-8dcc-dacd50741ead	17
1738566	menthol 100 MG/ML / methyl salicylate 120 MG/ML Topical Spray	SCD	ba5f4626-f077-4a28-8dcc-dacd50741ead	17
1738566	menthol 10 % / methyl salicylate 12 % Topical Spray	SY	ba5f4626-f077-4a28-8dcc-dacd50741ead	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50231-511-11	50231051111	118 mL in 1 BOTTLE (50231-511-11)	118 ml	2016-02-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Natureteq (as PLD) - MEDISTIK DUAL ACTION (50231-511)	Natureteq Inc.	2025-09-15	HUMAN OTC DRUG LABEL	17