FDA.reportPublic FDA data

UNIVERSAL ANTI-CAVITY FLUORIDE

Manufacturer
Universal Distribution Center LLC
Effective date
2023-11-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:31

Label at a glance#

ProductUNIVERSAL ANTI-CAVITY FLUORIDE
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Sodium Monofluorophosphate  0.76%

(1000 ppm)

OTC - PURPOSE SECTION

Purpose

Anticavity toothpaste

INDICATIONS & USAGE SECTION

Uses

  • regular brushing with flouride toothpaste helps protect teeth against cavities
  • aids in the prevention of dental cavities.

WARNINGS SECTION

Warning

OTC - WHEN USING SECTION

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.

OTC - STOP USE SECTION

Stop and ask a dentist

  • if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

  • If accidentally swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children of 2 years and older: brush teeth thoroughly, after meals or at least twice a day, or as directed by a dentist.
  • do not swallow.
  • to minimize swallowing, use a pea-sized amount in children under 6 years old.
  • supervise children's brushing until good habits are established.
  • children under 2 years: ask a dentist before use.

Children under 12 years of age: Consult a dentist or doctor

SPL UNCLASSIFIED SECTION

Other information

  • store in a cool, dry place.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Calcium carbonate, Water, Glycerine, Silica, Sodium Lauryl sulphate, Sorbitol, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium carboxy methyl cellulose and Flavor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

UNIVERSAL ANTI-CAVITY FLUORIDE TOOTHPASTE

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-111-01UNIVERSAL ANTI-CAVITY FLUORIDE181 g in 1 TUBEPASTE1812

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-111UNIVERSAL ANTI-CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 1 package rows20231121_e3356374-befa-41b0-ab0f-edfd5a062601.zip

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
52000-11152000-111-01

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 CARBONATEH0G9379FGKIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

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
UNIVERSAL ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLCe3356374-befa-41b0-ab0f-edfd5a0626012023-11-16WarningsExact identifier
ndc (package): 52000-111-01
ndc (product): 52000-111
ndc11 (package): 52000011101
spl id: 42b18d2a-c986-42a0-9f88-9ee8e8b1290b
spl set id: e3356374-befa-41b0-ab0f-edfd5a062601

Reported adverse events (FAERS/openFDA)#

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