FDA.reportPublic FDA data

Complete Care Whole Mouth Protection

Manufacturer
Church & Dwight Co., Inc.
Effective date
2025-09-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:22:22

Label at a glance#

ProductComplete Care Whole Mouth Protection
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

Directions do not swallow • supervise children as necessary until capable of using without supervision • rinse away toothpaste residue throughly after brushing 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 or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 year...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24%

(0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

Anticavity toothpaste

INDICATIONS & USAGE SECTION

aids in the prevention of dental decay

WARNINGS SECTION

Warnings
Do not use if irritation occurs and persists.

OTC - DO NOT USE SECTION

Do not useif irritation occurs and persists.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Directionsdo not swallow • supervise children as necessary until capable of using without supervision • rinse away toothpaste residue throughly after brushing

adults and children 2 years and olderbrush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 yearsinstruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 yearsask a dentist or physician

INACTIVE INGREDIENT SECTION

Water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, flavor, sodium lauryl sulfate, sodium lauroyl sarcosinate, poloxamer 407, sodium saccharin, xanthan gum, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?Call 1-800-786-5135Mon.-Fri. 9am-5pm ET or visit www.myoralcare.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Great

New

Formula!

Anticavity

Fluoride

Toothpaste

ARM AND HAMMER The Standard of Purity

UP TO 3X MORE PLAQUE REMOVAL*

COMPLETE CARE™

whole mouth protection

provides deep cleaning, whitening & gum health

fresh mint

ULTRA

SMOOTH

FORMULA

NET WT. 6.0 OZ. (170g)

AH Complete Care Artwork.jpgAH Complete Care Artwork.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN4
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD4
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY4
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY4
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130033200180531GTIN-13: 0033200180531
EAN-13: 0033200180531
GTIN-12: 033200180531
UPC-A: 033200180531
GTIN storage (14 digits): 00033200180531		AH Complete Care Artwork.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-675-09Complete Care Whole Mouth Protection1 in 1 CARTONPASTE, DENTIFRICE14
10237-675-09Complete Care Whole Mouth Protection25.5 g in 1 TUBEPASTE, DENTIFRICE25.54
10237-675-12Complete Care Whole Mouth Protection1 in 1 CARTONPASTE, DENTIFRICE14
10237-675-12Complete Care Whole Mouth Protection340 g in 1 TUBEPASTE, DENTIFRICE3404
10237-675-60Complete Care Whole Mouth Protection170 g in 1 TUBEPASTE, DENTIFRICE1704
10237-675-60Complete Care Whole Mouth Protection1 in 1 CARTONPASTE, DENTIFRICE14
10237-675-62Complete Care Whole Mouth Protection170 g in 1 TUBEPASTE, DENTIFRICE1704
10237-675-62Complete Care Whole Mouth Protection2 in 1 CARTONPASTE, DENTIFRICE24
10237-675-64Complete Care Whole Mouth Protection4 in 1 PACKAGEPASTE, DENTIFRICE44
10237-675-64Complete Care Whole Mouth Protection1 in 1 CARTONPASTE, DENTIFRICE14

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-67510237-675-60, 10237-675-09, 10237-675-12, 10237-675-62, 10237-675-64

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM BICARBONATE8MDF5V39QOIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
HYDRATED SILICAY6O7T4G8P9IACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
Complete Care Whole Mouth ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.d00f9d16-de0e-4ffc-e053-2a95a90a20692025-09-09WarningsExact identifier
ndc (package): 10237-675-09
ndc (package): 10237-675-12
ndc (package): 10237-675-64
ndc (package): 10237-675-62
ndc (package): 10237-675-60
ndc (product): 10237-675
ndc11 (package): 10237067564
ndc11 (package): 10237067562
ndc11 (package): 10237067560
ndc11 (package): 10237067509
ndc11 (package): 10237067512
spl id: 3e6329fb-e4f4-d077-e063-6394a90a7530
spl set id: d00f9d16-de0e-4ffc-e053-2a95a90a2069

Reported adverse events (FAERS/openFDA)#

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