FDA.reportPublic FDA data

Fluoride

Manufacturer
McKesson | Dabur India Limited
Effective date
2026-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:45

Label at a glance#

ProductFluoride
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each gram)
Sodium monofluorophosphate - 0.76% (Total fluoride content - 1000 ppm approx.)

OTC - PURPOSE SECTION

Purpose
Anticavity

INDICATIONS & USAGE SECTION

Uses
Regular brushing with fluoride toothpaste helps protect teeth against cavities.

WARNINGS SECTION

Warnings
Keep out of reach of children under 6 years of age.
ln case of accidental overdose, seek professional assistance or contact a Poison Control
Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings
Keep out of reach of children under 6 years of age.
ln case of accidental overdose, seek professional assistance or contact a Poison Control
Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 2 years & older:

Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.

  • Children under 6 years:

To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established.

  • Children under 2 years:

Ask a dentist or physician.

OTHER SAFETY INFORMATION

Store in a cool, dry, well-ventilated area.
Not made with natural rubber latex.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Calcium Carbonate, Sorbitol, Aqua, Silica, Sodium Lauryl Sulphate, Flavour, Sodium Silicate,
Tetra Sodium Pyrophosphate, Cellulose Gum, Xanthan Gum, Benzyl Alcohol, Sodium Saccharin, Sodium Benzoate.

OTC - QUESTIONS SECTION

Questions? Call 1-800-777-4908

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-9571-1
McKesson
MFR # 16-TPCFL15
Fluoride Toothpaste
MINT
ANTI-CAVITY WITH CALCIUM CARBONATE
Helps to protect against cavities and improve oral hygiene.
NET WEIGHT 1.5 oz (42.5 g)

C15C15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130612479281455GTIN-13: 0612479281455
EAN-13: 0612479281455
GTIN-12: 612479281455
UPC-A: 612479281455
GTIN storage (14 digits): 00612479281455		TPCFL15.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-9571-1Fluoride1 g in 1 TUBEPASTE11

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-957168599-9571-1

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
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
CALCIUM CARBONATEH0G9379FGKIACT
SODIUM LAURYL SULFATE368GB5141JIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM SILICATEIJF18F77L3IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
SILICAETJ7Z6XBU4IACT
TETRASODIUM PYROPHOSPHATEO352864B8ZIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM SACCHARINSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT

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
FluorideFLUORIDE TOOTHPASTEMcKesson4c482e45-0502-a93a-e063-6394a90aa9612026-03-05WarningsExact identifier
ndc (package): 68599-9571-1
ndc (product): 68599-9571
ndc11 (package): 68599957101
spl id: 4c482e45-0503-a93a-e063-6394a90aa961
spl set id: 4c482e45-0502-a93a-e063-6394a90aa961

Reported adverse events (FAERS/openFDA)#

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