FDA.reportPublic FDA data

Moon Whitening Anticavity

Manufacturer
Moon Oral Care, LLC
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:34:23

Label at a glance#

ProductMoon Whitening Anticavity
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.23% (0.117% w/v fluoride ion) Anticavity

OTC - PURPOSE SECTION

Anticavity

DOSAGE & ADMINISTRATION SECTION

Topical Paste

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

WARNINGS SECTION

Warning:

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Contains sodium fluoride. Children of 6 years and younger: Use a pea-sized amount with supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

INSTRUCTIONS FOR USE SECTION

Directions: Adults and children 2 years and older: Brush teeth thoroughly after meals at least twice a day or use as directed by a dentist. Do not swallow. To minimize swallowing, use a pea-sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 years ask a dentist

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

WATER, SORBITOL, HYDRATED SILICA, GLYCERIN, XYLITOL, MICA, CELLULOSE GUM, SODIUM LAUROYL SARCOSINATE, TITANIUM DIOXIDE, SACCHARIN SODIUM, CARRAGEENAN, FLAVOR, MENTHA ARVENSIS LEAF OIL, PEPPERMINT OIL, COCONUT OIL, CRANBERRY SEED OIL, TEA TREE OIL, SEA SALT, GREEN TEA LEAF, ECHINACEA ANGUSTIFOLIA LEAF, MYRCIARIA DUBIA FRUIT, ASIAN GINSENG, HYDROGEN PEROXIDE, ALPHA-ISOMETHYL IONONE, ENZYL SALICYLATE, COUMARIN, LIMONENE

Primary Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary TubePrimary Tube

Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489127sodium fluoride 0.23 % ToothpastePSN2
1489127sodium fluoride 0.0023 MG/MG ToothpasteSCD2
1489127sodium fluoride 0.23 % ToothpasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82214-002-01Moon Whitening Anticavity119 g in 1 TUBEPASTE1192
82214-002-02Moon Whitening Anticavity1 in 1 CARTONPASTE12

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82214-00282214-002-01, 82214-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDRATED SILICAY6O7T4G8P9IACT
MICAV8A1AW0880IACT
WATER059QF0KO0RIACT
SEA SALT87GE52P74GIACT
PEPPERMINT OILAV092KU4JHIACT
TEA TREE OILVIF565UC2GIACT
ASIAN GINSENGCUQ3A77YXIIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
MYRCIARIA DUBIA FRUITYSW4EM1EKPIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
COCONUT OILQ9L0O73W7LIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ECHINACEA ANGUSTIFOLIA LEAFFS7G8S6PJ8IACT
XYLITOLVCQ006KQ1EIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARRAGEENAN5C69YCD2YJIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
CRANBERRY SEED OIL73KDS3BW5EIACT
ALPHA-ISOMETHYL IONONE9XP4LC555BIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
LIMONENE, (+)-GFD7C86Q1WIACT
COUMARINA4VZ22K1WTIACT

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
Moon Whitening AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0bdcad3e-b8e9-bd91-e063-6394a90a666a2026-01-09WarningsExact identifier
ndc (package): 82214-002-02
ndc (package): 82214-002-01
ndc (product): 82214-002
ndc11 (package): 82214000201
ndc11 (package): 82214000202
spl id: 47fb8775-b211-a82b-e063-6394a90ae6d4
spl set id: 0bdcad3e-b8e9-bd91-e063-6394a90a666a

Reported adverse events (FAERS/openFDA)#

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