FDA.reportPublic FDA data

Bubble Fresh Toothpaste, with Fluoride

Product NDC
67777-191
11-digit product format
677770191
Labeler code
67777
Product ID
67777-191_2a2f5ed9-31ed-f6c8-e063-6394a90a44d6
Type
HUMAN OTC DRUG
Nonproprietary name
Bubble Fresh Toothpaste, with Fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Dynarex Corporation
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-15
Substance
SODIUM FLUORIDE
Active strength
220 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bubble Fresh Toothpaste, with Fluoride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE220 mg/g

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
245598Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2a2f5ed9-31ec-f6c8-e063-6394a90a44d6Available on FDA.report

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

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 52 · 1,033 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZONSENToothpasteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.5613faef-3469-569a-e063-6394a90ac32d2026-09-10WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN2a2f5ed9-31ec-f6c8-e063-6394a90a44d61
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD2a2f5ed9-31ec-f6c8-e063-6394a90a44d61
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY2a2f5ed9-31ec-f6c8-e063-6394a90a44d61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67777-191-016777701910124 g in 1 TUBE24 gHistorical
67777-191-0267777019102144 in 1 BOXHistorical
67777-191-03677770191035 BOX in 1 CASE (67777-191-03) / 144 TUBE in 1 BOX (67777-191-02) / 24 g in 1 TUBE (67777-191-01) 5 box2025-01-15NoNoCurrent
67777-191-046777701910442.5 g in 1 TUBE42.5 gHistorical
67777-191-0567777019105144 TUBE in 1 CASE (67777-191-05) / 42.5 g in 1 TUBE (67777-191-04) 144 tube2025-01-15NoNoCurrent
67777-191-066777701910678 g in 1 TUBE78 gHistorical
67777-191-076777701910772 TUBE in 1 CASE (67777-191-07) / 78 g in 1 TUBE (67777-191-06) 72 tube2025-01-15NoNoCurrent
67777-191-0867777019108130 g in 1 TUBE130 gHistorical
67777-191-09677770191091 in 1 BOXHistorical
67777-191-106777701911060 BOX in 1 CASE (67777-191-10) / 1 TUBE in 1 BOX (67777-191-09) / 130 g in 1 TUBE (67777-191-08) 60 box2025-01-15NoNoCurrent