FDA.reportPublic FDA data

Bubble Fresh Toothpaste, with Fluoride

Manufacturer
Dynarex Corporation
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:52:33

Label at a glance#

ProductBubble Fresh Toothpaste, with Fluoride
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Dosage and administration

• Adults and children 2 years of age and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. • Children under 6 years: To minimize swallowing, use a pea size amount and supervise child's brushing and rinsing until good habits are established. • Children under 2 years: Use as directed by a dentist or physician

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22%

Purpose

OTC - PURPOSE SECTION

Anticavity

Use(s)

INDICATIONS & USAGE SECTION

Helps protect against cavities

Warnings

WARNINGS SECTION

Do Not Swallow

Keep our to reach of children under 6 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years of age and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

• Children under 6 years: To minimize swallowing, use a pea size amount and supervise child's brushing and rinsing until good habits are established.

• Children under 2 years: Use as directed by a dentist or physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose Sodium, Flavor (Bubble Gum Flavor), Hydrated Silica Polyethylene Glycol 1450, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol

Other Information

OTHER SAFETY INFORMATION

Store between 15º - 35ºC (59º - 95ºF)

Questions?

OTC - QUESTIONS SECTION

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5917_BX_MASTER5917_BX_MASTER5917 Bubble Fresh Toothpaste with Fluoride

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5918_IN_MASTER5918_IN_MASTER5918 Bubble Fresh Toothpaste with Fluoride

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5919_IN-MASTER5919_IN-MASTER5919 Bubble Fresh Toothpaste with Fluoride

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5920_BX_MASTER5920_BX_MASTER5920 Bubble Fresh Toothpaste with Fluoride

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-191-01Bubble Fresh Toothpaste, with Fluoride24 g in 1 TUBEPASTE241
67777-191-02Bubble Fresh Toothpaste, with Fluoride144 in 1 BOXPASTE1441
67777-191-03Bubble Fresh Toothpaste, with Fluoride5 in 1 CASEPASTE51
67777-191-04Bubble Fresh Toothpaste, with Fluoride42.5 g in 1 TUBEPASTE42.51
67777-191-05Bubble Fresh Toothpaste, with Fluoride144 in 1 CASEPASTE1441
67777-191-06Bubble Fresh Toothpaste, with Fluoride78 g in 1 TUBEPASTE781
67777-191-07Bubble Fresh Toothpaste, with Fluoride72 in 1 CASEPASTE721
67777-191-08Bubble Fresh Toothpaste, with Fluoride130 g in 1 TUBEPASTE1301
67777-191-09Bubble Fresh Toothpaste, with Fluoride1 in 1 BOXPASTE11
67777-191-10Bubble Fresh Toothpaste, with Fluoride60 in 1 CASEPASTE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-191BUBBLE FRESH TOOTHPASTE, WITH FLUORIDE PASTE [DYNAREX CORPORATION]1Current NDC, 10 package rows20250115_2a2f5ed9-31ec-f6c8-e063-6394a90a44d6.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-19167777-191-01, 67777-191-02, 67777-191-03, 67777-191-04, 67777-191-05, 67777-191-06, 67777-191-07, 67777-191-08, 67777-191-09, 67777-191-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDRATED SILICAY6O7T4G8P9IACT
POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SORBITOL506T60A25RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT

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
Bubble Fresh Toothpaste, with FluorideBUBBLE FRESH TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a2f5ed9-31ec-f6c8-e063-6394a90a44d62024-12-26WarningsExact identifier
ndc (package): 67777-191-08
ndc (package): 67777-191-09
ndc (package): 67777-191-04
ndc (package): 67777-191-05
ndc (package): 67777-191-02
ndc (package): 67777-191-03
ndc (package): 67777-191-06
ndc (package): 67777-191-01
ndc (package): 67777-191-07
ndc (package): 67777-191-10
ndc (product): 67777-191
ndc11 (package): 67777019106
ndc11 (package): 67777019109
ndc11 (package): 67777019108
ndc11 (package): 67777019102
ndc11 (package): 67777019107
ndc11 (package): 67777019105
ndc11 (package): 67777019103
ndc11 (package): 67777019110
ndc11 (package): 67777019101
ndc11 (package): 67777019104
spl id: 2a2f5ed9-31ed-f6c8-e063-6394a90a44d6
spl set id: 2a2f5ed9-31ec-f6c8-e063-6394a90a44d6

Reported adverse events (FAERS/openFDA)#

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