FDA.reportPublic FDA data

ARC 2 in 1

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-06-03 17:52:28

Label at a glance#

ProductARC 2 in 1 Whitening and Anticavity
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Dosage and administration

adults and children 12 yrs. & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. do not swallow children under 12 yrs.: ask a dentist

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 1.14%

(0.17% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 12 yrs. 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

  • adults and children 12 yrs. & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
  • do not swallow
  • children under 12 yrs.: ask a dentist

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, calcium pyrophosphate,
hydrogen peroxide (4% w/v), sodium lauryl sulfate, flavor, polyacrylate
crosspolymer-6, cetearyl alcohol, disodium pyrophosphate, sucralose, tetrasodium
pyrophosphate

Questions?

OTC - QUESTIONS SECTION

1-866-989-3951

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

Crest 3D White Ultra White 85g tube in carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THE POWER OF

HYDROGEN PEROXIDE

ARC

WHITENING

FLUORIDE TOOTHPASTE

2-in-1

WHITENING

+ ANTICAVITY

BRIGHT MINT

NET WT 3.0 OZ (85 g)

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038995sodium monofluorophosphate 1.14 % ToothpastePSN5
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCD5
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSY5
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSY5
1038995sodium monofluorophosphate 1.14 % ToothpasteSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix90357259Capture.pdf.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-837-30ARC 2 in 1Whitening and Anticavity1 in 1 CARTONPASTE, DENTIFRICE15
69423-837-30ARC 2 in 1Whitening and Anticavity85 g in 1 TUBEPASTE, DENTIFRICE855

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-83769423-837-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM PYROPHOSPHATEX69NU20D19IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-02-25full-release2026-06-01 00:56:00

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
ARC 2 in 1 Whitening and AnticavitySODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company12634efa-35e3-76d7-e063-6294a90a3de42026-01-08Exact identifier
ndc (package): 69423-837-30
ndc (product): 69423-837
ndc11 (package): 69423083730
spl id: 47e520ba-9f2a-d002-e063-6394a90acac8
spl set id: 12634efa-35e3-76d7-e063-6294a90a3de4

Reported adverse events (FAERS/openFDA)#

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