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 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine 4% Patch	LIDOCAINE	Aldermed Inc.	57994923-20fc-9d9d-e063-6394a90a22c9	2026-07-27	Warnings	Exact identifier application number: M017
Lidocaine 4% Patch	LIDOCAINE	Aldermed Inc.	579a5012-837a-828b-e063-6294a90a4fb2	2026-07-27	Warnings	Exact identifier application number: M017
Original Pain Relief	TOPICAL ANALGESIC LOTION	Real Time Pain Relief Inc	579bd303-9a50-4d66-e063-6294a90a6141	2026-07-27	Warnings	Exact identifier application number: M017
Lidfix Pain Relief Patch Lidocaine	LIDOCAINE	HETERO HEALTHCARE LIMITED	2149f0e3-1983-4f02-929e-ecd20357f4bb	2026-07-27	Warnings	Exact identifier application number: M017
RectoProtect	LIDOCAINE	Akron Pharma Inc.	1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb	2026-07-27	Warnings	Exact identifier application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEF	MENTHOL	OWELL NATURAL 8 LLC	57a124b4-66c6-2474-e063-6294a90ab0d7	2026-07-27	Warnings	Exact identifier application number: M017
Icy Hot Performance Dry	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	8927570f-761b-4d83-8612-30077224fdb8	2026-07-27	Warnings	Exact identifier application number: M017
NUMBING	LIDOCAINE	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	578675e8-30e7-6986-e063-6394a90a8afe	2026-07-26	Warnings	Exact identifier application number: M017
Do Me Delay Cream	BENZOCAINE	Prodigy Media	53d5cd6b-96b8-9ba2-e063-6294a90a0d15	2026-07-24	Warnings	Exact identifier application number: M017
Bravado Labs Delay Cream	BENZOCAINE	Prodigy Media Inc	57269544-9cfb-4ff0-e063-6394a90adb02	2026-07-24	Warnings	Exact identifier application number: M017
Zytherial Lidocaine 4% Pain Relief Patch	LIDOCAINE 4% PAIN RELIEF PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56db5028-b631-7981-e063-6294a90ae395	2026-07-24	Warnings	Exact identifier application number: M017
AEROBURN	LIDOCAINE HYDROCHLORIDE	Aero Healthcare US LLC	f8fa72db-5f7a-4158-a2b3-f8bc0e12df9f	2026-07-24	Warnings	Exact identifier application number: M017
AEROSOOTHE	HYDROCORTISONE	Aero Healthcare US LLC	22b172a2-07e8-4ebb-b0a0-dfe4f25477fa	2026-07-24	Warnings	Exact identifier application number: M017
Lidocaine Plus Pain Relieving	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	CVS Pharmacy	49003aac-184c-ae33-e063-6294a90a29c0	2026-07-24	Warnings	Exact identifier application number: M017
Arlun Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5765fbf1-e835-a11e-e063-6394a90a5ac2	2026-07-24	Warnings	Exact identifier application number: M017
DERMFREE PAIN RELIEF	ARNICA MONTANA HPUS 7% PAIN RELIEF	Jiangxi Yudexi Pharmaceutical Co., LTD	4bb74112-c4e7-7988-e063-6394a90ae3f1	2026-07-24	Warnings	Exact identifier application number: M017
SERYNTH HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	4c667f3d-1238-2f02-e063-6394a90ab742	2026-07-24	Warnings	Exact identifier application number: M017
DERMFREE NUMBING	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4ca7222b-d754-9861-e063-6294a90a1b7b	2026-07-24	Warnings	Exact identifier application number: M017
REINREUDE BACK PAIN THERAPY	CAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPY	Jiangxi Yudexi Pharmaceutical Co., LTD	4ca7d0ca-6407-1fed-e063-6394a90aaccc	2026-07-24	Warnings	Exact identifier application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AID	NICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AID	Jiangxi Yudexi Pharmaceutical Co., LTD	4d5821f9-605e-5391-e063-6294a90afcd2	2026-07-24	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