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 133 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TheraCare 4% Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	c808aa05-9d49-cc9f-e053-2a95a90a50f3	2024-05-21	Warnings	Exact identifier application number: M017
TheraCare 4% Lidocaine and 1% Menthol Cream	MENTHOL AND LIDOCAINE	Veridian Healthcare	c80ba251-91a5-0858-e053-2995a90a9cff	2024-05-21	Warnings	Exact identifier application number: M017
HealthWise Menthol Roll-On	MENTHOL	Veridian Healthcare	102d57a5-6449-f825-e063-6294a90a8844	2024-05-21	Warnings	Exact identifier application number: M017
SAFLY Burn	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	3aca2568-d10f-4b14-861b-6c741c106829	2024-05-17	Warnings	Exact identifier application number: M017
HealthWise Menthol 4% Roll-On	MENTHOL	Veridian Healthcare	1894ef00-ba05-0e02-e063-6394a90ab982	2024-05-16	Warnings	Exact identifier application number: M017
Leader Poison Ivy Wash	PRAMOXINE HYDROCHLORIDE LOTION	Cardinal Health, 110 dba Leader	81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c	2024-05-13	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	0e808f89-62dc-3790-e063-6394a90a2351	2024-05-13	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Plus Cream	BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE	Walgreens Company	e33e0097-31d6-8083-e053-2a95a90af5d2	2024-05-09	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro Pain Relieving Cold Gel	CAMPHOR, MENTHOL	ACTIVE AND INNOVATIVE, LLC	1794c512-5f42-4ec3-e063-6394a90a87cd	2024-05-03	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro	MENTHOL AND CAMPHOR	ACTIVE AND INNOVATIVE, LLC	17961a84-6bee-c75f-e063-6394a90af576	2024-05-03	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Pain Relieving Creme	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd	2024-05-01	Warnings	Exact identifier application number: M017
Lidocaine HCl 4 Percent	LIDOCAINE HYDROCHLORIDE	ARI BRANDS, LLC	81aff5c5-91c0-4173-a432-d20115613580	2024-04-30	Warnings	Exact identifier application number: M017
HealthWise 3x Medicated Pain Relief Patch 120 Bulk	CAMPHOR,MENTHOL, METHYL SALICYLATE	Veridian Healthcare	17545078-05e1-9338-e063-6394a90a678c	2024-04-30	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro Roll-on	CAMPHOR, MENTHOL	ACTIVE AND INNOVATIVE, LLC	1755ec89-c404-1c17-e063-6394a90ab9fb	2024-04-30	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Roll On	MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f0bc2a14-6bda-428c-e053-2995a90a4ced	2024-04-29	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Tube	MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f0bec1d4-2e18-4519-e053-2a95a90a1bbb	2024-04-29	Warnings	Exact identifier application number: M017
THERAPLEX AIM Anti-Itch Moisturizing	HYDROCORTISONE	THERAPLEX, LLC	d1b231b6-cc9f-488a-9121-501831473772	2024-04-27	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE ACETATE	JHK Inc dba American Safety & First Aid	64adc8d0-7ca4-4c1a-813f-f1df47e916f2	2024-04-25	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Plus Cream	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	16f26249-b508-2c6e-e063-6394a90a265b	2024-04-25	Warnings	Exact identifier application number: M017
Hydrocortisone Cream with Aloe	HYDROCORTISONE	Cardinal Health 110 dba LEADER	16f2f3cb-4611-5867-e063-6394a90af107	2024-04-25	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