FDA.reportPublic FDA data

Enamel Defense

Manufacturer
Church & Dwight Co., Inc.
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:43

Label at a glance#

ProductEnamel Defense
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24%

OTC - PURPOSE SECTION

Anticavity toothpaste

INDICATIONS & USAGE SECTION

Use

aids in the prevention of dental decay

WARNINGS SECTION

Warnings

Do not use ifirritation 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 accidently swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not swallow
  • supervise children as necessary until capable of using without supervision
  • rinse away toothpaste residue thoroughly 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 years- ask a dentist or physician

INACTIVE INGREDIENT SECTION

sodium bicarbonate (baking soda), PEG-8, hydrated silica, glycerin, calcium sulfate, sodium lauryl sulfate, sodium saccharin, flavor, dipotassium phosphate, PEG/PPG 116/66 copolymer, sodium carbonate, calcium peroxide, mica, titanium dioxide

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ARM & HAMMER

THE STANDARD OF PURITY

Enamel Defense

Fluoride Anticavity Toothpaste

formerly known as BRIGHT & STRONG

REPAIRS AND PROTECTS ENAMEL SURFACE

Crisp Mint

NET WT 4.3 OZ. (121g)

LO_S01686C_2048783_R6LO_S01686C_2048783_R6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-666-09Enamel Defense1 in 1 CARTONPASTE, DENTIFRICE13
10237-666-09Enamel Defense25 g in 1 TUBEPASTE, DENTIFRICE253
10237-666-43Enamel Defense121 g in 1 TUBEPASTE, DENTIFRICE1213
10237-666-43Enamel Defense1 in 1 CARTONPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-666ENAMEL DEFENSE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]3Current NDC, Legacy NDC, 4 package rows20241123_9e8f1ce9-b161-50db-e053-2995a90ad32b.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-66610237-666-43, 10237-666-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YIACT
MICAV8A1AW0880IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BICARBONATE8MDF5V39QOIACT
HYDRATED SILICAY6O7T4G8P9IACT
CALCIUM SULFATE, UNSPECIFIED FORMWAT0DDB505IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZIACT
PEG/PPG-116/66 COPOLYMERJP0CK963E0IACT
SODIUM CARBONATE45P3261C7TIACT
CALCIUM PEROXIDE7FRO2ENO91IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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
Enamel DefenseSODIUM FLUORIDEChurch & Dwight Co., Inc.9e8f1ce9-b161-50db-e053-2995a90ad32b2024-11-20WarningsExact identifier
ndc (package): 10237-666-09
ndc (package): 10237-666-43
ndc (product): 10237-666
ndc11 (package): 10237066609
ndc11 (package): 10237066643
spl id: 2763d4eb-e0e9-c03a-e063-6394a90af967
spl set id: 9e8f1ce9-b161-50db-e053-2995a90ad32b

Reported adverse events (FAERS/openFDA)#

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