FDA.reportPublic FDA data

UNIVERSAL CHARCOAL WITH ALOE VERA 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 00:02:29

Label at a glance#

ProductUNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Sodium Fluoride-0.32% (0.15% w/v fluride ion)

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Uses

  • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets
  • 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

  • If accidentally swallowed while brushing, seek professional help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years of age and older
  • apply atleast 1-inch strip of product onto soft bristle toothbrush
  • brush teeth thoroughly for atleast 1 minute twice a day (morning and evening), and not more then 3 times a day, or as recommended by a dentist or doctor.
  • Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

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

Sorbitol, Silica, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium Lauryl sulphate, Water, Flavor, Charcoal powder, poly ethylene glycol 1500, Aloe vera.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE TOOTHPASTE

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN2
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD2
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY2
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY2
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY2
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-110-01UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE122 g in 1 TUBEPASTE1222

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-110UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE (SODIUM FLUORIDE) PASTE [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 1 package rows20231121_3411924d-1002-460c-83e8-c0c7fbff9ad1.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
52000-11052000-110-01

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
SORBITOL506T60A25RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDESODIUM FLUORIDEUniversal Distribution Center LLC3411924d-1002-460c-83e8-c0c7fbff9ad12023-11-16WarningsExact identifier
ndc (package): 52000-110-01
ndc (product): 52000-110
ndc11 (package): 52000011001
spl id: d0808a4c-4c1f-4bd1-a8b0-bf13a29bd1d4
spl set id: 3411924d-1002-460c-83e8-c0c7fbff9ad1

Reported adverse events (FAERS/openFDA)#

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