ORCA Complete Menthol Pain Reliever

Manufacturer: ORCA Products, LLC
Effective date: 2023-12-08
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:03:42

Label at a glance#

ProductORCA Complete Menthol Pain Reliever

Active ingredientMENTHOL, UNSPECIFIED FORM

Label structure9 sections

Dosage and administration

Adults and children 12 years of age and older: Place 8-10 drops onto ORCA Foam or similar resorbable gelatin sponge or gauze strip in a sterile fashion and apply to areas of discomfort in oral region. Guaze strip requires removal. Orca Foam soaked sponge will resorb and does not require removal. Children under 12 years of age should be supervised in use of this product. Children under 12 years of age: Consult a de...

Contacts and useful links#

PhoneLabel contact1-970-401-1138

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2%

Purpose

OTC - PURPOSE SECTION

oral pain reliever

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain due to minor irritation or injury of the mouth and gums

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

this product for more than 7 days unless directed by a dentist or doctor.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

sore mouth symptoms do not improve in 7 days
irritation, pain, or redness persists or worsens
swelling, rash, or fever develops

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Place 8-10 drops onto ORCA Foam or similar resorbable gelatin sponge or gauze strip in a sterile fashion and apply to areas of discomfort in oral region. Guaze strip requires removal. Orca Foam soaked sponge will resorb and does not require removal.
Children under 12 years of age should be supervised in use of this product.
Children under 12 years of age: Consult a dentist or doctor.

Other information

OTHER SAFETY INFORMATION

Do not use if tamperproof seal is not intact at time of first use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Clove oil, glycerin, guaiacol, oregano oil, peppermint oil.

Questions?

OTC - QUESTIONS SECTION

1-970-401-1138 MON-FRI 8 AM to 3 PM (CST)

Package Labeling: 82939-000-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelPrint Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2611702	menthol 2 % Mucous Membrane Topical Solution	PSN	3
2611702	menthol 20 MG/ML Mucous Membrane Topical Solution	SCD	3
2611702	menthol 2 % Mucous Membrane Topical Solution	SY	3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82939-000-01	ORCA Complete Menthol Pain Reliever	10 mL in 1 BOTTLE, GLASS	LIQUID	10	3
82939-000-01	ORCA Complete Menthol Pain Reliever	1 in 1 BOX	LIQUID	1	3
82939-000-02	ORCA Complete Menthol Pain Reliever	1 in 1 BOX	LIQUID	1	3
82939-000-02	ORCA Complete Menthol Pain Reliever	13 mL in 1 BOTTLE	LIQUID	13	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82939-000	ORCA COMPLETE MENTHOL PAIN RELIEVER (MENTHOL) LIQUID [ORCA PRODUCTS, LLC]	3	Current NDC, Legacy NDC, 4 package rows	20231209_99990e27-d66b-4d61-97f2-6a76066eb8b8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

ORCA Complete Menthol Pain Reliever
MENTHOL
CLOVE OIL
GLYCERIN
GUAIACOL
OREGANO LEAF OIL
PEPPERMINT OIL
MENTHOL, UNSPECIFIED FORM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82939-000	82939-000-01, 82939-000-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CLOVE OIL	578389D6D0	IACT
GLYCERIN	PDC6A3C0OX	IACT
GUAIACOL	6JKA7MAH9C	IACT
OREGANO LEAF OIL	7D0CGR40U1	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	ACTIB

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ORCA Complete Menthol Pain Reliever	MENTHOL	ORCA Products, LLC	99990e27-d66b-4d61-97f2-6a76066eb8b8	2023-12-08	Warnings	Exact identifier ndc (package): 82939-000-01 ndc (package): 82939-000-02 ndc (product): 82939-000 ndc11 (package): 82939000002 ndc11 (package): 82939000001 spl id: 0c06e3d2-4481-f4b5-e063-6394a90a0608 spl set id: 99990e27-d66b-4d61-97f2-6a76066eb8b8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.