Country Gent

Manufacturer: Heavenly Harvest, Inc.
Effective date: 2012-02-14
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:31:03

Label at a glance#

ProductCountry Gent

Active ingredientSODIUM FLUORIDE

Label structure7 sections

Dosage and administration

Adults and Children 6 years of age & older: Apply powder to wet toothbrush; completely cover bristles. Brush 30 seconds. Reapply powder as before and brush again. Rinse and expel thoroughly. Brush teeth, after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary...

Contacts and useful links#

PhoneLabel contact229.890.3288

Label contents#

Full prescribing information#

Active Ingredient (% by weight)

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride (0.188%)

Purpose

OTC - PURPOSE SECTION

For Cavity Prevention.

Indication

INDICATIONS & USAGE SECTION

Aids in prevention of dental decay.

KEEP OUT OF REACH OF CHIL-DREN UNDER 6 YRS OF AGE.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Sodium Bicarbonate, Peppermint Oil, Stevia Extract.

Directions For Use

DOSAGE & ADMINISTRATION SECTION

Adults and Children 6 years of age & older: Apply powder to wet toothbrush; completely cover bristles. Brush 30 seconds. Reapply powder as before and brush again. Rinse and expel thoroughly. Brush teeth, after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 6 years of age: Do not use unless directed by a dentist or doctor.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Country Gent

toothpaste powder

with fluoride

4 oz. (113 g) Net Wt - over 500 Brushings!

For centuries people used tooth powder as a natural,

safe, effective method for tooth care. Our tooth powder

cleans teeth and promotes healthy

gums by removing plaque.

Gluten Fee, Sulfate Free, Natura

Ingredients Produced by Nature with

Minimal Physical Processing. No

Animal Ingredients or Animal Testing.

Also, try Fluoride Free Products.

Naturally Charming, just as a Country Gent Should Be!

Biodegradable Packaging; MADE IN USA by Heavenly Harvest,

Inc., using ingredients and packaging that are

MADE IN USA

countrygentnatural.com

Questions? Call 229.890.3288

Products safe for customers, employees, & the earth's future.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66894-0000-1	2019-11-13	C162847	48780-1	97449f38-c97a-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66894-0000-1	Country Gent	113 g in 1 BOTTLE	POWDER, DENTIFRICE	113		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66894-0000	COUNTRY GENT (SODIUM FLUORIDE) POWDER, DENTIFRICE [HEAVENLY HARVEST, INC.]	1	Legacy NDC, 1 package rows	20120302_b0a72b13-14a5-4086-a05c-6c9a515374ce.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	1
STEVIA REBAUDIANA WHOLE	INACTIVE INGREDIENT	6U422Y08O2	1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Country Gent
SODIUM FLUORIDE
FLUORIDE ION
CALCIUM CARBONATE
SODIUM BICARBONATE
PEPPERMINT OIL
STEVIA REBAUDIANA WHOLE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66894-0000	66894-0000-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
CALCIUM CARBONATE	H0G9379FGK	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
STEVIA REBAUDIANA WHOLE	6U422Y08O2	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 70 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, COATED / ORAL	10.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET / BUCCAL		42 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SYRUP / ORAL		120 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / RESPIRATORY (INHALATION)	4.02 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / INTRAVENOUS	4.02 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	GRANULE, EFFERVESCENT / ORAL	267 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	POWDER, DENTIFRICE / DENTAL	0.5 mg/mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, CHEWABLE / ORAL		1650 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, DELAYED RELEASE / ORAL	8.4 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAVENOUS	812 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, EFFERVESCENT / ORAL		57600 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET / SUBLINGUAL	0.15 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	CONCENTRATE / ORAL	0.05 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET / ORAL	1300 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, FILM COATED / ORAL		300 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	SOLUTION / ORAL	ADJ PH		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1000 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, EXTENDED RELEASE / ORAL		81 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAMUSCULAR		175 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, ORALLY DISINTEGRATING / ORAL		107 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	FILM / BUCCAL		12 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		3059 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SPRAY, METERED / SUBLINGUAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 34 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SUSPENSION / ORAL	100 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / AURICULAR (OTIC)	0.38 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	CAPSULE / ORAL		60 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	GUM, CHEWING / BUCCAL		240 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	SOLUTION / RESPIRATORY (INHALATION)	2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, EXTENDED RELEASE / ORAL	229.7 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	CAPSULE / ORAL		320 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		3219 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, CHEWABLE / ORAL	140 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAVITREAL	0.18 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	ELIXIR / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	PASTE, DENTIFRICE / DENTAL	49.3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS		160 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	CAPSULE, DELAYED RELEASE PELLETS / ORAL		4 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SOLUTION / ORAL		53 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRATHECAL	0.05 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	FILM, SOLUBLE / ORAL		14 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / BUCCAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE / ORAL	349.9 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET / ORAL		28 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, FILM COATED / ORAL		86 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	GUM, CHEWING / BUCCAL		3492 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / ORAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	LOZENGE / ORAL		12 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	POWDER, FOR SOLUTION / ORAL	1250 mg/100ml		Exact identifier — unii candidate 34 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, COATED / ORAL	64.8 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	POWDER / SUBLINGUAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SOLUTION / DENTAL	0.04 %v/v		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL	ADJ PH		Exact identifier — unii candidate 34 equally ranked IID candidates

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
b0a72b13-14a5-4086-a05c-6c9a515374ce			b0a72b13-14a5-4086-a05c-6c9a515374ce	2012-02-14	Warnings	Exact identifier spl id: b0a72b13-14a5-4086-a05c-6c9a515374ce spl set id: b0a72b13-14a5-4086-a05c-6c9a515374ce

Reported adverse events (FAERS/openFDA)#

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