Fluoride - McKesson | Dabur India Limited

Manufacturer
McKesson | Dabur India Limited
Effective date
2026-04-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:54:52

Label at a glance#

ProductFluoride
Active ingredientSODIUM FLUORIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each gram)
Sodium Fluoride - 0.243% (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose
Anticavity

INDICATIONS & USAGE SECTION

Uses
Aids in the prevention of dental cavities.

WARNINGS SECTION

Warnings
Keep out of reach of children under 6 years of age.
If you accidentally swallow more than used for brushing, seek professional
help or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.
If you accidentally swallow more than used for brushing, seek professional
help 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.
Do not swallow.
Instruct children under 6 years of age in good brushing and rinsing habits
(to minimize swallowing, use a pea-sized amount).
Supervise children's brushing until good habits are established.
Children under 2 years: Consult a dentist or doctor.

OTHER SAFETY INFORMATION

Store in a cool, dry, well-ventilated area.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Sorbitol, Silica, Treated Water, Glycerin, PEG-32, Sodium Lauryl Sulfate, Flavor,
Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Phosphate, Sodium Saccharin,
Sodium Benzoate, Tetrasodium Pyrophosphate, FD&C Blue # 1.

OTC - QUESTIONS SECTION

Questions? Call 1-800-777-4908

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-9573-1
MFR # 16-TPFL085
NET WEIGHT 0.85 oz (24.1 g)

McKesson

Fluoride Toothpaste
MINT, ANTI-CAVITY
Helps to protect against cavities and improve oral hygiene.

085085

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-9573-2
MFR # 16-TPFL15
NET WEIGHT 1.5 oz (42.5 g)

McKesson

Fluoride Toothpaste
MINT, ANTI-CAVITY
Helps to protect against cavities and improve oral hygiene.

1515

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 68599-9573-3
MFR # 16-TPFL275
NET WEIGHT 2.75 oz (78 g)

McKesson

Fluoride Toothpaste
MINT, ANTI-CAVITY
Helps to protect against cavities and improve oral hygiene.

275275

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-9573-4
MFR # 16-TPFL4
NET WEIGHT 4 oz (113.4 g)

McKesson

Fluoride Toothpaste
MINT, ANTI-CAVITY
Helps to protect against cavities and improve oral hygiene.

44

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN1
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD1
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-9573-1Fluoride24.1 g in 1 TUBEPASTE24.11
68599-9573-2Fluoride42.5 g in 1 TUBEPASTE42.51
68599-9573-3Fluoride78 g in 1 TUBEPASTE781
68599-9573-4Fluoride113.4 g in 1 TUBEPASTE113.41

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
68599-957368599-9573-1, 68599-9573-2, 68599-9573-3, 68599-9573-4

Ingredients#

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

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

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
FluorideSODIUM FLUORIDEMcKesson5025e58e-e59c-07b6-e063-6394a90ac1e82026-04-23WarningsExact identifier
ndc (package): 68599-9573-4
ndc (package): 68599-9573-3
ndc (package): 68599-9573-2
ndc (package): 68599-9573-1
ndc (product): 68599-9573
ndc11 (package): 68599957304
ndc11 (package): 68599957302
ndc11 (package): 68599957303
ndc11 (package): 68599957301
spl id: 5025e58e-e59d-07b6-e063-6394a90ac1e8
spl set id: 5025e58e-e59c-07b6-e063-6394a90ac1e8

Reported adverse events (FAERS/openFDA)#

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