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 126 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Anti Itch	HYDROCORTISONE	L. Perrigo Company	ecd6d841-40b9-42c9-825d-d172cd04824d	2024-10-03	Warnings	Exact identifier application number: M017
Gold Bond Medicated Original Strength Body	MENTHOL	Navajo Manufacturing Company Inc.	f71d598c-92c3-d6fd-e053-6394a90a97d7	2024-10-03	Warnings	Exact identifier application number: M017
Signature Care Hydrocortisone	HYDROCORTISONE	Safeway	9e663535-4acc-4b37-acae-8c17517c5a3d	2024-10-03	Warnings	Exact identifier application number: M017
Topcare Hydrocortisone	HYDROCORTISONE	Topco Associates LLC	849c60fc-e455-4c50-8adf-ac59c0ee785b	2024-10-03	Warnings	Exact identifier application number: M017
rexall anti itch maximum strength relief	HYDROCORTISONE	Dolgencorp, LLC	894cf9ab-693a-4210-96df-605947f51b63	2024-10-03	Warnings	Exact identifier application number: M017
equaline anti itch maximum strength	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	070000d7-7d4d-439b-9a91-851ba7c027e6	2024-10-03	Warnings	Exact identifier application number: M017
hydrocortisone anti itch	HYDROCORTISONE	H E B	a1a9fed8-4938-48b5-81f1-d3942d534bb8	2024-10-03	Warnings	Exact identifier application number: M017
equaline anti itch	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	ef9ea069-9b97-4bf5-aaac-deb85334dbd0	2024-10-03	Warnings	Exact identifier application number: M017
Basic Care Hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	7fa13ab4-5f2d-4a48-816f-1b22d5f757b2	2024-10-03	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	dc388dc1-0c4f-4bf1-8a12-fa39892317bc	2024-10-02	Warnings	Exact identifier application number: M017
Geliga Muscular	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	fb2beb08-0ad6-a89d-e053-6294a90aa6fe	2024-10-02	Warnings	Exact identifier application number: M017
Geliga Muscular Balm	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	da28097f-4b5c-6159-e053-2a95a90a7d96	2024-10-02	Warnings	Exact identifier application number: M017
Circatrix	CAPSAICIN	PureTek Corporation	cd3b1256-2df8-dc26-e053-2a95a90ad049	2024-10-02	Warnings	Exact identifier application number: M017
DermacinRx Penetral Cream	CAPSAICIN	PureTek Corporation	1e343a52-6071-3230-e054-00144ff8d46c	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Aromatic	CAMPHOR MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	36abfc2c-d424-4df8-968d-866342c96a56	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Balm	CAMPHOR MENTHOL	Eagle Indo Pharma, PT	87614869-9675-2c76-e053-2a95a90a48a9	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	d9a93daa-4e24-6690-e053-2a95a90a147c	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Extra Strength	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	5e02fbe3-5bc7-430e-b661-3a760ddd8fe0	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Oil Refreshing	MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	c62a4313-2c07-5f58-e053-2995a90a083a	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Aromatic	CAMPHOR MENTHOL METHYL SALICYLATE	Eagle Indo Pharma, PT	e272ec90-3cd9-5b70-e053-2a95a90a1df4	2024-10-02	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