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

Reported adverse events (FAERS/openFDA)#

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

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 24 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro Health Sensitive and Enamel ShieldSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb48b15c-f821-e5cd-e053-6294a90ac64c2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Luminous PurpleSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyfbfcd837-4d88-5f82-e053-6394a90afbf62026-01-08WarningsExact identifier
application number: M021
Crest Pro Health with a Touch of ScopeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb572b41-36cd-55d7-e053-6394a90a71c82026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Whitening GelSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb5b1e94-bed6-8486-e053-6294a90a3a842026-01-08WarningsExact identifier
application number: M021
Crest 3D White Ultra Vivid MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companycba96ef0-0519-059f-e053-2a95a90a43ad2026-01-08WarningsExact identifier
application number: M021
Crest 4in1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyce545406-3c4f-1ba7-e053-2a95a90a91ac2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd218ddc0-1d5f-f39b-e053-2995a90a96ed2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Antibacterial ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd58bc842-2687-e52d-e053-2995a90a54332026-01-08WarningsExact identifier
application number: M021
Scope Stay StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd65b3153-2026-a8c0-e053-2a95a90a31d62026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Whitening CharcoalSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6f68485-b92f-41c7-e053-2995a90a4fe52026-01-08WarningsExact identifier
application number: M021
KIDS Crest Advanced Enamel Plus Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd837ecde-249a-7868-e053-2a95a90a56ae2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Whitening Intensive CleaningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6fa4187-a651-647b-e053-2995a90a85672026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Gum ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7729dde-c828-34e6-e053-2a95a90a5ee62026-01-08WarningsExact identifier
application number: M021
Crest Densify Daily WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd811306f-4994-7a5a-e053-2995a90adf162026-01-08WarningsExact identifier
application number: M021
Crest Densify Daily ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd810d4e5-ba66-efe1-e053-2995a90abfc02026-01-08WarningsExact identifier
application number: M021
Crest Braces Care Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd823cba4-c4cf-7d7a-e053-2995a90a01f02026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Sensitive ReliefSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7730674-7513-52cf-e053-2995a90ab32c2026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum FlavorSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company26a7a892-5da4-4749-bbb6-566efab7d7492026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Plus ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8c91095d-88c0-4d22-a79a-7d0f0d05302b2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Deep Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd774295f-8ebd-9877-e053-2a95a90a9a0e2026-01-08WarningsExact 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