KERACARE

Product NDC: 63766-001
11-digit product format: 637660001
Labeler code: 63766
Product ID: 63766-001_2413c890-1c9f-cfe9-e063-6394a90a1927
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol 1%
Dosage form: GEL
Route: TOPICAL
Labeler: Avlon Industries, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-04-06
Marketing end: 2027-07-17
Substance: MENTHOL
Active strength: 10 mg/g
NDC exclude flag: No
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: KERACARE

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	10 mg/g

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
1039043	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
f72eec6d-1204-4e03-8aed-d5bcf8d3bbce	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63766-001-01	2024-02-29	KeraCare Dry & Itchy Scalp Glossifier
63766-001-02	2024-02-29	KeraCare Dry & Itchy Scalp Glossifier
63766-001-01	2024-01-30	KeraCare Dry & Itchy Scalp Glossifier
63766-001-02	2024-01-30	KeraCare Dry & Itchy Scalp Glossifier

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63766-001-01	KERACARE	110 g in 1 CANISTER	GEL	110		6
63766-001-02	KERACARE	200 g in 1 CANISTER	GEL	200		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
.ALPHA.-AMYLCINNAMALDEHYDE	INACTIVE INGREDIENT	WC51CA3418	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
BENZYL SALICYLATE	INACTIVE INGREDIENT	WAO5MNK9TU	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
BUTYLPHENYL METHYLPROPIONAL	INACTIVE INGREDIENT	T7540GJV69	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
CINNAMYL ALCOHOL	INACTIVE INGREDIENT	SS8YOP444F	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
D&C RED NO. 17	INACTIVE INGREDIENT	ND733RX3JN	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
EUGENOL	INACTIVE INGREDIENT	3T8H1794QW	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
GERANIOL	INACTIVE INGREDIENT	L837108USY	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
HYDROXYCITRONELLAL	INACTIVE INGREDIENT	8SQ0VA4YUR	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
ISOEUGENOL	INACTIVE INGREDIENT	5M0MWY797U	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
ISOMETHYL-.ALPHA.-IONONE	INACTIVE INGREDIENT	9XP4LC555B	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
LIMONENE, (+/-)-	INACTIVE INGREDIENT	9MC3I34447	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
LINALOOL, (+/-)-	INACTIVE INGREDIENT	D81QY6I88E	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
SULFUR	INACTIVE INGREDIENT	70FD1KFU70	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63766-001	KERACARE (MENTHOL 1%) GEL [AVLON INDUSTRIES, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20241012_f72eec6d-1204-4e03-8aed-d5bcf8d3bbce.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 2 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ActivICE	MENTHOL	Medline Industries, LP	834adeb9-38ad-0cfe-e053-2991aa0af82f	2026-09-01	Warnings	Exact identifier application number: M017
La Vaquita New Extra	METHYL SALICYLATE, MENTHOL	Delon Laboratories (1990) Ltd	3097a01b-cee5-492f-b65a-63992fb28e3a	2026-09-01	Warnings	Exact identifier application number: M017
Terramed Just Think Comfort Hydrocortisone 1% Cream	HYDROCORTISONE	Rida LLC	0d2c0c2c-370f-4adb-b0ea-1e218c927f8b	2026-09-01	Warnings	Exact identifier application number: M017
Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	HyVee Inc	53157137-b980-45d2-aa10-8c111c0ec2f4	2026-08-31	Warnings	Exact identifier application number: M017
EAYONYUMT NECK PAIN RELIEF	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a450e68-07a7-a4bb-e063-6294a90a97c9	2026-08-30	Warnings	Exact identifier application number: M017
EAYONYUM BACK PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a458280-4f9c-5af6-e063-6394a90acb2e	2026-08-30	Warnings	Exact identifier application number: M017
EAYONYUM KNEE PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a45d19f-c753-71eb-e063-6294a90a4805	2026-08-30	Warnings	Exact identifier application number: M017
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skin	HYDROCORTISONE	AmerisourceBergen	c5c5b5ca-b4d4-4fa8-b647-b3ccb2966495	2026-08-30	Warnings	Exact identifier application number: M017
Olu Pain Management	LIDOCAINE AND CAMPHOR	HAWAII REPACK, INC.	31ed3d82-ba12-46b2-b0ec-7e5e019efc10	2026-08-28	Warnings	Exact identifier application number: M017
4% Lidocaine Patches	4% LIDOCAINE PATCHES	Shenzhen Chaoxiji Technology Co.,Ltd.	5a177987-7c05-f07f-e063-6394a90aa9ba	2026-08-28	Warnings	Exact identifier application number: M017
Relieved Pro Wrap	4% LIDOCAINE PATCH	Transfer Technology	5a1c6ebf-ad3f-c47b-e063-6294a90aa19a	2026-08-28	Warnings	Exact identifier application number: M017
Sinsinpas Arex Pain Relieving Patch, Medium	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sinsin Pharmaceutical Co., Ltd.	46453ef2-512b-4852-e063-6394a90a8912	2026-08-28	Warnings	Exact identifier application number: M017
Sinsinpas arex patch large	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sinsin Pharmaceutical Co., Ltd.	47c242da-56cd-bea1-e063-6394a90a41de	2026-08-28	Warnings	Exact identifier application number: M017
4% Lidocaine Patches	4% LIDOCAINE PATCHES	Shenzhen Chaoxiji Technology Co.,Ltd.	5a16c6aa-3ab0-3e46-e063-6294a90a6d8f	2026-08-27	Warnings	Exact identifier application number: M017
Lidocaine Patch 4%	LIDOCAINE 4%	Global America Group LLC	1eec782d-0e56-43d2-b842-da0ae47c5dc9	2026-08-26	Warnings	Exact identifier application number: M017
Careland Lidocaine Plus Menthol Pain Relieving	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd	0f928b5b-60f5-4a45-a409-c601eb330487	2026-08-26	Warnings	Exact identifier application number: M017
PARCHE CALIENTE	CAPSAICINA AND MENTOL	DW SUPPORT LLC	59f2708e-295a-ccb3-e063-6394a90ad395	2026-08-26	Warnings	Exact identifier application number: M017
CVS Pain Relief	LIDOCAINE	CVS Pharmacy	4ecbc263-e0d4-18d5-e063-6294a90a72e9	2026-08-26	Warnings	Exact identifier application number: M017
CVS Pain Relief Lidocaine XL	LIDOCAINE	CVS Pharmacy	4aa286e3-e274-8095-e063-6394a90ae871	2026-08-26	Warnings	Exact identifier application number: M017
TERAPIA DE DIA Y NOCHE	PAIN RELIEVING PATCH	DW SUPPORT LLC	59f44135-865b-9d7d-e063-6294a90a9dd9	2026-08-26	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1039043	menthol 1 % Topical Gel	PSN	f72eec6d-1204-4e03-8aed-d5bcf8d3bbce	6
1039043	menthol 0.01 MG/MG Topical Gel	SCD	f72eec6d-1204-4e03-8aed-d5bcf8d3bbce	6
1039043	menthol 1 % Topical Gel	SY	f72eec6d-1204-4e03-8aed-d5bcf8d3bbce	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63766-001-01	63766000101	110 g in 1 CANISTER (63766-001-01)	110 g	2014-04-06	2027-07-17	No	No	Current
63766-001-02	63766000102	200 g in 1 CANISTER (63766-001-02)	200 g	2014-04-06	2027-06-10	No	No	Current