FDA.reportPublic FDA data

Sodium Fluoride 1.1% Dental Gel BUBBLEGUM

Product NDC
71085-079
Requested package NDC
71085-079-02
11-digit product format
710850079
Labeler code
71085
Product ID
71085-079_397f50b5-c9e0-62fc-e063-6294a90ae7ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
GEL
Route
ORAL
Labeler
IPG PHARMACEUTICALS, INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-07-01
Substance
SODIUM FLUORIDE
Active strength
1.1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Fluoride 1.1% Dental Gel BUBBLEGUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1486566Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5fb07d97-ce03-416f-a4a2-75c23cfebc05Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71085-079-02Sodium Fluoride 1.1% Dental Gel BUBBLEGUM1 in 1 CARTONGEL11
71085-079-02Sodium Fluoride 1.1% Dental Gel BUBBLEGUM200 g in 1 TUBEGEL2001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71085-079-02GM - Gram71085-0793f4a0c9e-046d-403c-be64-51b79cc1518112025-08-11

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
Sodium Fluoride 1.1% Dental Gel BUBBLEGUMSODIUM FLUORIDEIPG PHARMACEUTICALS, INC.5fb07d97-ce03-416f-a4a2-75c23cfebc052025-07-09WarningsExact identifier
ndc (package): 71085-079-02
ndc (product): 71085-079
ndc11 (package): 71085007902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486566sodium fluoride 1.1 % Oral GelPSN5fb07d97-ce03-416f-a4a2-75c23cfebc051
1486566sodium fluoride 0.011 MG/MG Oral GelSCD5fb07d97-ce03-416f-a4a2-75c23cfebc051
1486566sodium fluoride 1.1 % Oral GelSY5fb07d97-ce03-416f-a4a2-75c23cfebc051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71085-079-02710850079021 TUBE in 1 CARTON (71085-079-02) / 200 g in 1 TUBE1 tube2025-07-01NoNoCurrent