OTC - ACTIVE INGREDIENT SECTION
Active Ingredent
Sodium Monofluorophosphate 0.76%
Active Ingredent
Sodium Monofluorophosphate 0.76%
Purpose
Anticavity toothpaste
Use
Aids in the prevention of cavities
If more than is used for brushing is accidentally swallowed get medical help or contact a poison control center right away.
Keep out of reach of children under 6 yrs of age.
Directions
adults and children 2 years. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.
do not swallow
to minimize swallowing, use a pea-sized amount in children under 6 years old
supervise children's brushing until good habits are established
children under 2y ears: ask a dentist before use.
Inactive ingredients-
calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, saccharin sodium, sodium lauryl sulfate, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum.
CAVITY FIGHTING TOOTHPASTE
Distributed by:
Personal Care Products, LLC
Bingham Farms, MI 48025-2463
Made in China
Advanced Fluoride Anticavity Toothpaste
New Ultra Breath Freshener Stripe
Net Wt 6.4oz (181g)
Multi
Protection
Fights Cavities
Freshens Breath
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 545626 | sodium monofluorophosphate 0.76 % Toothpaste | PSN | 5 |
| 545626 | sodium monofluorophosphate 0.0076 MG/MG Toothpaste | SCD | 5 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste | SY | 5 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste | SY | 5 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste | SY | 5 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste | SY | 5 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 29500-0819-6 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c52a-8e05-e053-dbdaa90a074a | ADVANCED FLUORIDE ANTICAVITY TOOTHPASTE |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 29500-0819-6 | ADVANCED FLUORIDE ANTICAVITY | 181 g in 1 TUBE | PASTE, DENTIFRICE | 181 | 5 | |
| 29500-0819-6 | ADVANCED FLUORIDE ANTICAVITY | 1 in 1 BOX | PASTE, DENTIFRICE | 1 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 29500-0819 | ADVANCED FLUORIDE ANTICAVITY (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERSONAL CARE PRODUCTS, LLC] | 5 | Legacy NDC, 2 package rows | 20110822_594d5fbc-a134-45ac-a8a7-d4d49d753ac7.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM MONOFLUOROPHOSPHATE | ACTIVE INGREDIENT | C810JCZ56Q | 5 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 5 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 5 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | 5 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 5 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 5 | |
| HYDRATED SILICA | INACTIVE INGREDIENT | Y6O7T4G8P9 | 5 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 5 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | 5 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 5 | |
| SORBITAN MONOOLEATE | INACTIVE INGREDIENT | 06XEA2VD56 | 5 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 5 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 29500-0819 | 29500-0819-6 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET / SUBLINGUAL | 28 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PASTE / DENTAL | 1.5 %w/w | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | CAPSULE, DELAYED RELEASE / ORAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | PASTE, DENTIFRICE / DENTAL | NA | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | LIQUID / ORAL | NA | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | CAPSULE / ORAL | 401 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER / ORAL | 275 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, CHEWABLE / ORAL | 6 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | SOLUTION / ORAL | 1080 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | AEROSOL, FOAM / TOPICAL | 0.27 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, COATED / ORAL | 40.2 mg | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET / BUCCAL | 60 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | LOTION / TOPICAL | 111 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SUSPENSION / ORAL | 705 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | POWDER / VAGINAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | SUPPOSITORY / RECTAL | 390 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PASTE, DENTIFRICE / DENTAL | 1.4 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SUSPENSION / ORAL | 85 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / DENTAL | 0.05 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RESPIRATORY (INHALATION) | NA | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRA-ARTICULAR | 45 %w/v | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, EXTENDED RELEASE / ORAL | 320 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | SPONGE / TOPICAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | POWDER / RESPIRATORY (INHALATION) | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FOR SUSPENSION / ORAL | 6 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| aa6d87e0-cfa1-4cc0-af22-0036fca25bfd | 594d5fbc-a134-45ac-a8a7-d4d49d753ac7 | 2011-08-18 | Warnings | aa6d87e0-cfa1-4cc0-af22-0036fca25bfd 594d5fbc-a134-45ac-a8a7-d4d49d753ac7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.