DARBY APF BUBBLE GUM

Manufacturer
Darby Dental Supply, LLC
Effective date
2023-01-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:46:12

Label at a glance#

ProductDARBY APF STRAWBERRY
Active ingredientSODIUM FLUORIDE
Label structure18 sections

Dosage and administration

l. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment.

Label contents#

Full prescribing information#

Strawberry

SPL UNCLASSIFIED SECTION

FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.

Directions For Use

DOSAGE & ADMINISTRATION SECTION

l. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment.

Medical Ingredients

DESCRIPTION SECTION

Fluoride Ions 1.23% w/w (from 2.72% w/w sodium fluoride).

Non-Medical Ingredients

SPL UNCLASSIFIED SECTION

Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, strawberry flavor.

Warnings

WARNINGS SECTION

KEEP OUT OF REACH OF CHILDREN. For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104° F (40°C). Contents under pressure. Do not puncture or incinerate. Do not use if seal is broken.

SPL UNCLASSIFIED SECTION

To reorder: Call 800.645.2310 or visit darby.com

Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753

NDC 66467-8003∙2

Reorder# 9510050

1900196

Mint

SPL UNCLASSIFIED SECTION

FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.

Directions For Use

DOSAGE & ADMINISTRATION SECTION

l. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment.

Medical Ingredients

DESCRIPTION SECTION

Fluoride Ions 1.23% w/w (from 2.72% w/w sodium fluoride).

Non-Medical Ingredients

SPL UNCLASSIFIED SECTION

Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, mint flavor.

Warnings

WARNINGS SECTION

KEEP OUT OF REACH OF CHILDREN. For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104° F (40°C). Contents under pressure. Do not puncture or incinerate. Do not use if seal is broken.

SPL UNCLASSIFIED SECTION

To reorder: Call 800.645.2310 or visit darby.com

Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753

NDC 66467-8004∙2

Reorder# 9510051

1900197

Bubble Gum

SPL UNCLASSIFIED SECTION

FOR PROFESSIONAL USE ONLY. A topical anti-caries preparation.

Directions For Use

DOSAGE & ADMINISTRATION SECTION

l. Following prophylaxis treatment, fill l/4 of tray with foam. 2. To dispense, shake can vigorously then invert applicator 180° downward to the bottom of the tray. 3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes. 4. Remove tray and have patient expectorate excess. 5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment.

Medical Ingredients

DESCRIPTION SECTION

Fluoride Ions 1.23% w/w (from 2.72% w/w sodium fluoride).

Non-Medical Ingredients

SPL UNCLASSIFIED SECTION

Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, bubble gum flavor.

Warnings

WARNINGS SECTION

KEEP OUT OF REACH OF CHILDREN. For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104° F (40°C). Contents under pressure. Do not puncture or incinerate. Do not use if seal is broken.

SPL UNCLASSIFIED SECTION

To reorder: Call 800.645.2310 or visit darby.com

Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753

NDC 66467-8005∙2

Reorder# 9510052

1900198

PRINCIPAL DISPLAY PANEL - 125 g Can Label - Strawberry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

darby
darby dental supply, llc

TOPICAL
FLUORIDE FOAM
2.72% TOPICAL SODIUM FLUORIDE FOAM
1.23% FLUORIDE IONS

130 Applications | 4.4 oz (125 g)

Strawberry

PRINCIPAL DISPLAY PANEL - 125 g Can Label - Strawberry
PRINCIPAL DISPLAY PANEL - 125 g Can Label - Strawberry

PRINCIPAL DISPLAY PANEL - 125 g Can Label - Mint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

darby
darby dental supply, llc

TOPICAL
FLUORIDE FOAM
2.72% TOPICAL SODIUM FLUORIDE FOAM
1.23% FLUORIDE IONS

130 Applications | 4.4 oz (125 g)

Mint

PRINCIPAL DISPLAY PANEL - 125 g Can Label - Mint
PRINCIPAL DISPLAY PANEL - 125 g Can Label - Mint

PRINCIPAL DISPLAY PANEL - 125 g Can Label - Bubble Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

darby
darby dental supply, llc

TOPICAL
FLUORIDE FOAM
2.72% TOPICAL SODIUM FLUORIDE FOAM
1.23% FLUORIDE IONS

130 Applications | 4.4 oz (125 g)

Bubble Gum

PRINCIPAL DISPLAY PANEL - 125 g Can Label - Bubble Gum
PRINCIPAL DISPLAY PANEL - 125 g Can Label - Bubble Gum

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
248389sodium fluoride 2.72 % Oral FoamPSN2
248389sodium fluoride 27.2 MG/ML Oral FoamSCD2
248389sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral FoamSY2
248389sodium fluoride 2.72 % Oral FoamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66467-8003-2DARBY APF STRAWBERRY125 g in 1 CANAEROSOL, FOAM1252
66467-8004-2DARBY APF MINT125 g in 1 CANAEROSOL, FOAM1252
66467-8005-2DARBY APF BUBBLE GUM125 g in 1 CANAEROSOL, FOAM1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66467-8003DARBY APF STRAWBERRY (SODIUM FLUORIDE) AEROSOL, FOAM DARBY APF MINT (SODIUM FLUORIDE) AEROSOL, FOAM DARBY APF BUBBLE GUM (SODIUM FLUORIDE) AEROSOL, FOAM [DARBY DENTAL SUPPLY, LLC]2Current NDC, Legacy NDC, 1 package rows20230113_222b29dc-7ad0-4872-9922-970efad8b7a7.zip
66467-8004DARBY APF STRAWBERRY (SODIUM FLUORIDE) AEROSOL, FOAM DARBY APF MINT (SODIUM FLUORIDE) AEROSOL, FOAM DARBY APF BUBBLE GUM (SODIUM FLUORIDE) AEROSOL, FOAM [DARBY DENTAL SUPPLY, LLC]2Current NDC, Legacy NDC, 1 package rows20230113_222b29dc-7ad0-4872-9922-970efad8b7a7.zip
66467-8005DARBY APF STRAWBERRY (SODIUM FLUORIDE) AEROSOL, FOAM DARBY APF MINT (SODIUM FLUORIDE) AEROSOL, FOAM DARBY APF BUBBLE GUM (SODIUM FLUORIDE) AEROSOL, FOAM [DARBY DENTAL SUPPLY, LLC]2Current NDC, Legacy NDC, 1 package rows20230113_222b29dc-7ad0-4872-9922-970efad8b7a7.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66467-800366467-8003-2
66467-800466467-8004-2
66467-800566467-8005-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 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
DARBY APF STRAWBERRYSODIUM FLUORIDEDarby Dental Supply, LLC222b29dc-7ad0-4872-9922-970efad8b7a72023-01-12WarningsExact identifier
ndc (package): 66467-8005-2
ndc (package): 66467-8004-2
ndc (package): 66467-8003-2
ndc (product): 66467-8003
ndc (product): 66467-8005
ndc (product): 66467-8004
ndc11 (package): 66467800402
ndc11 (package): 66467800302
ndc11 (package): 66467800502
spl id: 41a2c0a1-baac-4a89-b8f7-b980c2a2f63f
spl set id: 222b29dc-7ad0-4872-9922-970efad8b7a7

Reported adverse events (FAERS/openFDA)#

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