FDA.reportPublic FDA data

GuruNanda Anticavity

Manufacturer
GURUNANDA, LLC
Effective date
2026-01-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:33:52

Label at a glance#

ProductGuruNanda Anticavity
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

Adults and children 6 years of age and older Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinising. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary u...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.05%

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in prevention of dental cavities

Warnings

WARNINGS SECTION

Warnings

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older

  • Use once a day after brushing your teeth with a toothpaste.
  • Vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out.
  • Do not swallow the rinse.
  • Do not eat or drink for 30 minutes after rinising.
  • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until they are capable of using it without supervision.

Children under 6 years of age

  • Consult a dentist or doctor

Other information

OTHER SAFETY INFORMATION

  • Do not use if printed seal is broken or missing
  • Recommended storage temperature 59°F-77°F (15°C-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Xylitol, Glycerin, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Flavor, Menthol, Disodium Phosphate, Tea Tree Oil, Cinnamon Bark Oil, Citric Acid, Green Tea Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0892708927

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN3
240698sodium fluoride 0.5 MG/ML MouthwashSCD3
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810051089271GTIN-13: 0810051089271
EAN-13: 0810051089271
GTIN-12: 810051089271
UPC-A: 810051089271
GTIN storage (14 digits): 00810051089271		08927.1.jpg
QR code linkQR Codel.ead.me/bb4rmI08927.1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70708-927-16GuruNanda Anticavity499 mL in 1 BOTTLE, PLASTICMOUTHWASH4993

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70708-92770708-927-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
GREEN TEA LEAFW2ZU1RY8B0IACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AIACT
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
CINNAMON BARK OILXE54U569ECIACT
TEA TREE OILVIF565UC2GIACT
CITRIC ACID2968PHW8QPIACT
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
DISODIUM PHOSPHATE22ADO53M6FIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuruNanda AnticavitySODIUM FLUORIDEGURUNANDA, LLC3e90d516-3172-3c8d-e063-6294a90a394f2026-01-19WarningsExact identifier
ndc (package): 70708-927-16
ndc (product): 70708-927
ndc11 (package): 70708092716
spl id: 48c6afc2-5f6a-09e2-e063-6294a90ada5d
spl set id: 3e90d516-3172-3c8d-e063-6294a90a394f

Reported adverse events (FAERS/openFDA)#

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