FDA.reportPublic FDA data

Moon Charcoal Whitening Anticavity

Manufacturer
Moon Oral Care, LLC
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:04:10

Label at a glance#

ProductMoon Charcoal Whitening Anticavity
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Sodium Fluoride 0.24% (0.13% w/v fluoride ion) Anticavity

OTC - PURPOSE SECTION

Use aids in the prevention of dental cavities

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.

INDICATIONS & USAGE SECTION

Children of 6 years and younger: Use a pea sized amount with supervised brushing to minimize swallowing.

WARNINGS SECTION

Warning

Contains Sodium Fluoride. In case of intake of fluoride from other sources consult a dentist or doctor.

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children 2 years and older:

brush teeth thoroughly after meals or 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

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Glycerin, Hydrated Silica, Sorbitol, Water/Aqua/Eau, Sodium Cocoyl Glutamate, Sodium Coco-Sulfate, Sodium Hexametaphosphate, Disodium Pyrophosphate, Stevia Rebaudiana Leaf Extract, Cocos Nucifera (Coconut) Oil, Mentha Piperita (Peppermint) Oil, Mentha Arvensis Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Sea Salt, Echinacea Angustifolia Leaf Extract, Camellia Sinensis (Black and Green Teas) Leaf Extract, Panax Ginseng Root Extract, Mrciaria Dubia (Camu Camu) Fruit Extract, Carbon (Activated Charcoal), Sodium Benzoate, Titanium Dioxide, Chondrus Crispus Extract, Sodium Gluconate, Xanthan Gum, Sucralose, Citric Acid, Mica

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OuterOuter

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82214-003-01Moon Charcoal Whitening Anticavity119 g in 1 TUBEPASTE1191
82214-003-02Moon Charcoal Whitening Anticavity1 in 1 CARTONPASTE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82214-003MOON CHARCOAL WHITENING ANTICAVITY (SODIUM FLUORIDE) PASTE [MOON ORAL CARE, LLC]1Current NDC, 2 package rows20231214_0c55f7b3-fea1-58f3-e063-6394a90a3bde.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82214-00382214-003-01, 82214-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MICAV8A1AW0880IACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
COCONUT OILQ9L0O73W7LIACT
TEA TREE OILVIF565UC2GIACT
CRANBERRY SEED OIL73KDS3BW5EIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ASIAN GINSENGCUQ3A77YXIIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
SEA SALT87GE52P74GIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM COCO-SULFATE3599J29ANHIACT
SORBITOL506T60A25RIACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
ECHINACEA ANGUSTIFOLIA LEAFFS7G8S6PJ8IACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
PEPPERMINT OILAV092KU4JHIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
MYRCIARIA DUBIA FRUITYSW4EM1EKPIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
GLYCERINPDC6A3C0OXIACT
SODIUM GLUCONATER6Q3791S76IACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT

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 Charcoal Whitening AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c55f7b3-fea1-58f3-e063-6394a90a3bde2023-12-12WarningsExact identifier
ndc (package): 82214-003-02
ndc (package): 82214-003-01
ndc (product): 82214-003
ndc11 (package): 82214000302
ndc11 (package): 82214000301
spl id: 0c55f7b3-fea2-58f3-e063-6394a90a3bde
spl set id: 0c55f7b3-fea1-58f3-e063-6394a90a3bde

Reported adverse events (FAERS/openFDA)#

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