K19 RELIEF

Product NDC: 83574-413
11-digit product format: 835740413
Labeler code: 83574
Product ID: 83574-413_2bbc8ed1-176c-27a5-e063-6394a90a38ee
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: LIQUID
Route: TOPICAL
Labeler: K19 LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-07-10
Substance: MENTHOL
Active strength: 12.5 mg/mL
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
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	83574-413		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	83574-413	83574-413-00	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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: K19 RELIEF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	12.5 mg/mL

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
1606487	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
e2e1ca96-1ae8-4c99-b8de-ce26754292f9	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83574-413-00	K19 RELIEF	295 mL in 1 BOTTLE, SPRAY	LIQUID	295		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83574-413	K19 RELIEF (MENTHOL) LIQUID [K19 LLC]	3	Current NDC, 1 package rows	20250116_e2e1ca96-1ae8-4c99-b8de-ce26754292f9.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 125 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
terrasil Bruise and Pain Relief Maximum Strength	CAMPHOR, MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	240b231d-a8b2-c64c-e063-6394a90a7440	2024-10-09	Warnings	Exact identifier application number: M017
Muscle Freeze Relief	MENTHOL	NATURAL ESSENTIALS, INC.	815c534b-096d-49f2-b5f2-8c885d45a5e6	2024-10-09	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	VIVE HEALTH LLC	2410dc2f-9332-19fa-e063-6394a90a2835	2024-10-09	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain-Relieving	LIDOCAINE	Natural Essentials, Inc.	fc23b2e2-4abc-4119-b8bd-305b4327f1dd	2024-10-09	Warnings	Exact identifier application number: M017
KERACARE	MENTHOL 1%	Avlon Industries, Inc.	f72eec6d-1204-4e03-8aed-d5bcf8d3bbce	2024-10-09	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Eagle Indo Pharma, PT	da338796-de9c-be51-e053-2a95a90a2509	2024-10-07	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Eagle Indo Pharma	e2c5f821-cdd5-190d-e053-2a95a90a9159	2024-10-07	Warnings	Exact identifier application number: M017
NanoXtreme Pain Relieving	MENTHOL, METHYL SALICYLATE	MG Science Technologies LLC	c1490c30-a9db-4120-adaf-9e8000169e46	2024-10-07	Warnings	Exact identifier application number: M017
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc	ea656cf8-cad5-4fa5-82e7-daec77a0bb04	2024-10-07	Warnings	Exact identifier application number: M017
Eagle Medicated Oil Refreshing	MENTHOL, METHYL SALICYLATE	Eagle Indo Pharma, PT	e2729023-d689-7ae2-e053-2a95a90a78dc	2024-10-06	Warnings	Exact identifier application number: M017
Flanax Back Pain Relief	LIDOCAINE	Belmora LLC	46d33346-e582-4af1-b81a-feca7033dceb	2024-10-04	Warnings	Exact identifier application number: M017
Muscle Balm	MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)	Natural Essentials, Inc.	16918ba3-2e07-4232-9ed3-4c7751796cd2	2024-10-04	Warnings	Exact identifier application number: M017
Fast Freeze Pain Relieving Continuous	MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	998a4824-9ed9-4fe0-b45b-72e52861fcd3	2024-10-04	Warnings	Exact identifier application number: M017
Fast Freeze Lidocaine Roll-On	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	Natural Essentials, Inc.	74b06366-5eb4-4eba-aa2b-2b672828294d	2024-10-04	Warnings	Exact identifier application number: M017
Fast Freeze Lidocaine	LIDOCAINE	Natural Essentials, Inc.	029bd3fb-1b5b-48e0-b9af-d91d548b5b0f	2024-10-04	Warnings	Exact identifier application number: M017
Fast Freeze	MENTHOL	Natural Essentials Inc.	a96e3e41-871c-4cf3-93b6-af2a6246ded8	2024-10-04	Warnings	Exact identifier application number: M017
CVS Pain Relief	MENTHOL 4%	CVS	20234356-5e80-b79e-e063-6294a90a2ee3	2024-10-04	Warnings	Exact identifier application number: M017
FLANAX BACK PAIN RELIEF	LIDOCAINE	Belmora Llc	af4bf57c-f250-4506-83eb-e0f253e96062	2024-10-04	Warnings	Exact identifier application number: M017
topcare hydrocortisone	HYDROCORTISONE	Topco Associates LLC	11a30ec9-ebc2-4a00-8a8d-431d0d973b37	2024-10-03	Warnings	Exact identifier application number: M017
pain relief patch	LIDOCAINE 4%	Bionpharma Inc.	19c69983-4e78-8ec5-e063-6394a90a84be	2024-10-03	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1606487	menthol 1.25 % Topical Spray	PSN	e2e1ca96-1ae8-4c99-b8de-ce26754292f9	3
1606487	menthol 12.5 MG/ML Topical Spray	SCD	e2e1ca96-1ae8-4c99-b8de-ce26754292f9	3
1606487	menthol 1.25 % Topical Spray	SY	e2e1ca96-1ae8-4c99-b8de-ce26754292f9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83574-413-00	83574041300	295 mL in 1 BOTTLE, SPRAY (83574-413-00)	295 ml	2023-07-10	No	No	Current