FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
KERACARE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1039043

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63766-001-012024-02-29C16284748780-11030e365-60ea-111a-e063-dadaa90a10e2KeraCare Dry & Itchy Scalp Glossifier
63766-001-022024-02-29C16284748780-11030e365-60ea-111a-e063-dadaa90a10e2KeraCare Dry & Itchy Scalp Glossifier
63766-001-012024-01-30C16284748780-11030e365-60ea-111a-e063-dadaa90a10e2KeraCare Dry & Itchy Scalp Glossifier
63766-001-022024-01-30C16284748780-11030e365-60ea-111a-e063-dadaa90a10e2KeraCare Dry & Itchy Scalp Glossifier

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63766-001-01KERACARE110 g in 1 CANISTERGEL1106
63766-001-02KERACARE200 g in 1 CANISTERGEL2006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3AKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
MentholACTIVE MOIETYL7T10EIP3AKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
.ALPHA.-AMYLCINNAMALDEHYDEINACTIVE INGREDIENTWC51CA3418KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TUKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
BUTYLPHENYL METHYLPROPIONALINACTIVE INGREDIENTT7540GJV69KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
CINNAMYL ALCOHOLINACTIVE INGREDIENTSS8YOP444FKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
D&C RED NO. 17INACTIVE INGREDIENTND733RX3JNKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
EUGENOLINACTIVE INGREDIENT3T8H1794QWKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
GERANIOLINACTIVE INGREDIENTL837108USYKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
HYDROXYCITRONELLALINACTIVE INGREDIENT8SQ0VA4YURKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
ISOEUGENOLINACTIVE INGREDIENT5M0MWY797UKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
ISOMETHYL-.ALPHA.-IONONEINACTIVE INGREDIENT9XP4LC555BKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
LIMONENE, (+/-)-INACTIVE INGREDIENT9MC3I34447KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88EKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
SULFURINACTIVE INGREDIENT70FD1KFU70KERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIKERACARE (MENTHOL 1%) GEL, DENTIFRICE [AVLON INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63766-001KERACARE (MENTHOL 1%) GEL [AVLON INDUSTRIES, INC.]6Current NDC, Legacy NDC, 2 package rows20241012_f72eec6d-1204-4e03-8aed-d5bcf8d3bbce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039043menthol 1 % Topical GelPSNf72eec6d-1204-4e03-8aed-d5bcf8d3bbce6
1039043menthol 0.01 MG/MG Topical GelSCDf72eec6d-1204-4e03-8aed-d5bcf8d3bbce6
1039043menthol 1 % Topical GelSYf72eec6d-1204-4e03-8aed-d5bcf8d3bbce6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63766-001-0163766000101110 g in 1 CANISTER (63766-001-01) 110 g2014-04-062027-07-17NoNoCurrent
63766-001-0263766000102200 g in 1 CANISTER (63766-001-02) 200 g2014-04-062027-06-10NoNoCurrent