KERACARE

Product NDC: 63766-001
Requested package NDC: 63766-001-01
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

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 1 of 154 · 3,068 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Cardinal Health, 110 dba Leader	3ed7b8a1-012f-459d-878c-813b93d4673c	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M017
Gel Cooling Pain Relief	MENTHOL	The Kroger Co.	6fb0acc8-8dab-452c-b09e-de97306e1c32	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M017
Lidocaine Tattoo Wipe	LIDOCAINE HYDROCHLORIDE	MD Tattoo Company	369c1d16-597c-e1dc-e063-6394a90a3104	2026-08-06	Warnings	Exact identifier application number: M017
Point Relief Coldspot Pain Relieving	MENTHOL	Fabrication Enterprises Inc	479fb728-4aeb-42e3-b238-f04255514baa	2026-08-05	Warnings	Exact identifier application number: M017
Lidocaine HCl	LIDOCAINE HCL	Topco Associates LLC	584e1f35-4d99-9c85-e063-6294a90ab3d0	2026-08-05	Warnings, Adverse reactions	Exact identifier application number: M017
tuiwaro LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	56e36592-a935-61d4-e063-6294a90a6e4c	2026-08-04	Warnings	Exact identifier application number: M017
Mineral Ice Extreme Menthol Pain Relief	MENTHOL	Carlin Consumer Health LLC	584f5c6e-3385-3221-e063-6294a90aabae	2026-08-04	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	2026-08-04	Warnings	Exact identifier application number: M017
procure	HYDROCORTISONE ACETATE	TWIN MED, LLC	2670c9c4-66ad-40e8-a08a-582b160de39d	2026-08-03	Warnings	Exact identifier application number: M017
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On	MENTHOL	Chattem, Inc.	aa40c907-eeb5-4fda-b35e-439cbecc178c	2026-07-31	Warnings	Exact identifier application number: M017
Alphamale Delay Cream	BENZOCAINE	Prodigy Media Inc	53d682ee-0802-a16d-e063-6394a90aeee1	2026-07-31	Warnings	Exact identifier application number: M017
Pure Primal Delay Cream	BENZOCAINE	Prodigy Media Inc	57e9e894-c14f-d806-e063-6394a90ab8e5	2026-07-31	Warnings	Exact identifier application number: M017
Satohap	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	df0e2b83-8f61-4ed8-bcc4-55e4ea782090	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	cb000134-92a4-4304-8ef0-0347190e1414	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic Hot	CAPSAICIN	Sato Pharmaceutical Co., Ltd.	16b47cb5-ea5f-4514-9a89-141ee4cc60f8	2026-07-31	Warnings	Exact identifier application number: M017
Satohap Cool and Hot Pads	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceutical Co., Ltd.	b6bf1eab-4ab9-f500-e053-2995a90a8d7b	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017
SATOHAP COOL and HOT	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceuticals Co., Ltd.	232a4c76-1a0c-2f4b-e063-6394a90a8849	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017
Cortizone 10 Itch Relief Massaging Rollerball	HYDROCORTISONE	Chattem, Inc.	1e27682c-f856-41f1-9935-37540960a4c7	2026-07-31	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Exact identifier application number: M017
ACOLYE Lidocaine Cream Topical Analgesia Cream	LIDOCAINE,MENTHOL	Guangdong Aimu Biological Technology Co., Ltd	57deebf7-52f1-4256-e063-6294a90a75d5	2026-07-30	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