Indications and uses
Clinpro 5000 Anti-Cavity Toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries.
Clinpro 5000
- Manufacturer
- Solventum US LLC
- Effective date
- 2024-08-01
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-05-31 21:09:34
Label at a glance#
ProductClinpro 5000
Active ingredientsodium fluoride
Label structure15 sections
Dosage and administration
• Use once daily in place of conventional toothpaste unless instructed otherwise by a physician or dentist. • Apply a thin ribbon or pea-sized amount of Clinpro 5000 Anti-Cavity Toothpaste using a soft-bristled toothbrush and brush teeth for at least two minutes. • After brushing adults should expectorate. Children 6 to 16 years of age should expectorate and rinse mouth thoroughly with water. • Follow these instru...
Storage and handling
Clinpro 5000 Anti-Cavity Toothpaste is supplied as a white dentifrice paste in a 4 oz. (113 gm) plastic tube (NDC 48878-3120-4, Vanilla Mint Flavor; NDC 48878-3130-4 Spearmint Flavor; NDC 48878-3140-4 Bubble Gum Flavor). Storage This product is designed to be stored and used at room temperature. Do not freeze or expose to extreme heat. See outer package for expiration date. Manufactured for: 3M ESPE Dental Product...
Contacts and useful links#
Websitewww.3mespe.com
www.3MESPE.com
www.3MESPE.comWebsitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchLabel contents#
Full prescribing information#
1 INDICATIONS AND USAGE
Clinpro 5000 Anti-Cavity Toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries.
2 DOSAGE AND ADMINISTRATION
• Use once daily in place of conventional toothpaste unless instructed otherwise by a physician or dentist.
• Apply a thin ribbon or pea-sized amount of Clinpro 5000 Anti-Cavity Toothpaste using a soft-bristled toothbrush and brush teeth for at least two minutes.
• After brushing adults should expectorate. Children 6 to 16 years of age should expectorate and rinse mouth thoroughly with water.
• Follow these instructions or use as directed by a dental professional.
3 DOSAGE FORMS AND STRENGTHS
White toothpaste containing 1.1% sodium fluoride
4 CONTRAINDICATIONS
Do not use in children under 6 years of age unless recommended by a dentist or physician.
5 WARNINGS AND PRECAUTIONS
• DO NOT SWALLOW. If more than a pea-sized amount of Clinpro 5000 Anti-Cavity Toothpaste is swallowed, contact a medical or dental professional or a poison control center.
• Keep out of reach of children under 6 years of age.
• Repeated ingestion of high levels of fluoride may cause dental fluorosis. For this reason, use in children with developing dentition requires special supervision to prevent swallowing. Prescribing dentists and physicians should consider risk of fluorosis when prescribing for use in children less than 6 years of age.
6 ADVERSE REACTIONS
Allergic reactions and other idiosyncrasies have been rarely reported.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Fluoride crosses the placenta in women and has been measured in cord blood, amniotic fluid, and serum of newborn children, but without a consistent correlation to maternal serum fluoride levels.1,2 There are no data to indicate an increased susceptibility to fluorosis during pregnancy. Developmental studies were conducted by the National Toxicology Program, with sodium fluoride administered in the drinking water to pregnant rats and rabbits. No developmental toxicity was observed, even at doses that caused maternal toxicity. The No Adverse Effect Levels were about 29 mg/kg-day and 27 mg/kg-day for rabbits and rats, respectively.3 There is no conclusive evidence of fluoride developmental effects in humans.1,2
The Institute of Medicine established a fluoride Upper Limit of 10 mg/day for pregnant women.2
Prescribing physicians and dentists should consider total fluoride exposure (dental care plus food, water and other sources) when prescribing the product for use in pregnant women or women who may become pregnant.
8.3 Nursing Mothers
An extremely small proportion of fluoride in drinking water is transferred to breast milk. The Institute of Medicine established a fluoride Upper Limit of 10 mg/day for nursing women.2 Prescribing physicians and dentists should consider total fluoride exposure (dental care plus food, water and other sources) when prescribing the product for use in women who are nursing.
8.4 Pediatric Use
The primary adverse effects of fluoride are fluorosis of dental enamel and of the skeleton; these effects occur at exposures below those associated with other adverse health effects. The population most at risk for dental fluorosis is children during the period of tooth formation, i.e. from birth to 8 years of age. For this population, the Institute of Medicine established Fluoride Upper Limits of intake based on the risk of dental fluorosis. In populations with permanent dentition, skeletal fluorosis is the greatest risk from excessive fluoride. For this population the Institute of Medicine (IOM) established Fluoride Upper Limits based on the risk of skeletal fluorosis.2
| Population | IOM Fluoride Upper Limit |
| Infants 0-6 months old | 0.7 mg/day |
| Infants 7-12 months old | 0.9 mg/day |
| Children 1-3 years old | 1.3 mg/day |
| Children 4-8 years old | 2.2 mg/day |
| Children > 8 years old | 10 mg/day |
Prescribing physicians and dentists should consider total fluoride exposure (dental care plus food, water and other sources) when prescribing the product for use in children.
8.5 Geriatric Use
No studies of Clinpro 5000 Anti-Cavity Toothpaste have been conducted to determine whether subjects aged 65 and over respond differently from younger subjects.
10 OVERDOSAGE
Ingestion of large amounts of fluoride may result in abdominal pain, stomach upset, nausea, vomiting, and diarrhea. These symptoms may occur at overdosages of 5 mg/kg of body weight. Fluoride doses of 16 mg/kg have been fatal.
| Treatment Recommendations for Overdose of Clinpro 5000 Anti-Cavity Toothpaste4 | ||
| Ingested fluoride dose | Amount for 10 kg (22 pound) child* | Recommended action to take |
| Less than 5 mg/kg | This equals less than ½ ounce (or less than 3 teaspoons). | Do not induce vomiting. Give 1-2 glasses of milk and observe for symptoms of stomach upset. If symptoms persist more than a few hours, seek medical attention or contact a poison control center. |
| 5 mg/kg or more | This equals about ½ ounce (about 1 tablespoon) or more. | Do not induce vomiting. Give 1-2 glasses of milk and seek medical attention or contact a poison control center. |
| 15 mg/kg | This equals 1 ounce or ¼ of the tube. | Seek immediate medical attention. Do not induce vomiting. Give 1-2 glasses of milk. |
| *The amount to reach the fluoride dose will be proportionately larger with older children and adults. A thin ribbon or pea-sized amount of Clinpro 5000 Anti-Cavity Toothpaste weighs approximately 0.3 g and contains approximately 1.5 mg of fluoride ion. A 4 oz. tube contains 564 mg of fluoride ion. | ||
11 DESCRIPTION
Clinpro 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste is a self-applied fluoride dentifrice for the prevention of dental caries. Each gram contains 5 mg of fluoride ion in a neutral pH base, consisting of water, sorbitol, hydrated silica, glycerin, polyethylene-polypropylene glycol, flavor, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, carboxymethyl cellulose, sodium saccharin and tri-calcium phosphate.
12 CLINICAL PHARMACOLOGY
Clinpro 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste aids in the prevention of tooth decay. Fluoride delivered from Clinpro 5000 inhibits the demineralization of sound teeth and enhances the remineralization (i.e., repair) of demineralized teeth. During tooth brushing, fluoride is taken up by teeth and dental plaque. Fluoride is taken up with calcium and phosphate by demineralized teeth resulting in an improved tooth structure than contains more fluoride and less carbonate than naturally occurring tooth structure and is more resistant to acid challenge. Additionally, calcium fluoride is formed on the crystal structure of teeth. As the pH of the mouth drops, fluoride is released from calcium fluoride and aids in the remineralization of teeth. Fluoride taken up into plaque alters the activity of cariogenic bacteria. Fluoride inhibits the process by which cariogenic bacteria metabolize carbohydrates resulting in less acid and adhesive polysaccharide production by the bacteria.
15 REFERENCES
- National Research Council. Fluoride in drinking water: A scientific review of EPA's standards; National Academies Press 2006.
- IOM. Dietary Reference Intakes: The essential guide to nutrient requirements. National Academies Press 2006.
- Heindel JJ, et al. Developmental toxicity evaluation of sodium fluoride administered to rats and rabbits in drinking water. Fundam Appl Toxicol 1996;30(2):162-177.
- Poisindex. Toxicologic Management – Fluoride. Thomson Micromedex.
16 HOW SUPPLIED/STORAGE AND HANDLING
Clinpro 5000 Anti-Cavity Toothpaste is supplied as a white dentifrice paste in a 4 oz. (113 gm) plastic tube (NDC 48878-3120-4, Vanilla Mint Flavor; NDC 48878-3130-4 Spearmint Flavor; NDC 48878-3140-4 Bubble Gum Flavor).
STORAGE AND HANDLING SECTION
Storage
This product is designed to be stored and used at room temperature. Do not freeze or expose to extreme heat. See outer package for expiration date.
Manufactured for:
3M ESPE
Dental Products
2510 Conway Avenue
St. Paul, MN 55144-1000 USA
Revision date: 01/11/2012
Rx Only
3M, ESPE, and Clinpro are trademarks of 3M or 3M Deutschland GmbH.
© 3M 2016. All rights reserved.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel – Box Label
3M ESPE
NDC 48878-3120-4
Clinpro™ 5000
Vanilla Mint
1.1% Sodium Fluoride
Anti-Cavity Toothpaste
Innovative
Tri-Calcium
Phosphate
Exclusively from 3M ESPE
Contents: 1 Tube NET WT 4oz (113g)
Rx Only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel – Box Label
3M ESPE
NDC 48878-3130-4
Clinpro™ 5000
Spearmint
1.1% Sodium Fluoride
Anti-Cavity Toothpaste
Innovative
Tri-Calcium
Phosphate
Exclusively from 3M ESPE
Contents: 1 Tube NET WT 4oz (113g)
Rx Only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel – Box Label
3M ESPE
NDC 48878-3140-4
Clinpro™ 5000
Bubble Gum
1.1% Sodium Fluoride
Anti-Cavity Toothpaste
Innovative
Tri-Calcium
Phosphate
Exclusively from 3M ESPE
Contents: 1 Tube NET WT 4oz (113g)
Rx Only
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1006558 | Clinpro 5000 1.1 % Toothpaste | PSN | 9 |
| 392038 | sodium fluoride 1.1 % Toothpaste | PSN | 9 |
| 1006558 | sodium fluoride 0.011 MG/MG Toothpaste [Clinpro 5000] | SBD | 9 |
| 392038 | sodium fluoride 0.011 MG/MG Toothpaste | SCD | 9 |
| 1006558 | Clinpro 5000 0.011 MG/MG Toothpaste | SY | 9 |
| 1006558 | Clinpro 5000 1.1 % Toothpaste | SY | 9 |
| 392038 | sodium fluoride 1.1 % (fluoride ion 0.5 % ) Toothpaste | SY | 9 |
| 392038 | sodium fluoride 1.1 % Dental Gel | SY | 9 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48878-3120-4 | Clinpro 5000 | 1 in 1 BOX | PASTE, DENTIFRICE | 1 | 9 | |
| 48878-3120-4 | Clinpro 5000 | 113 g in 1 TUBE | PASTE, DENTIFRICE | 113 | 9 | |
| 48878-3130-4 | Clinpro 5000 | 113 g in 1 TUBE | PASTE, DENTIFRICE | 113 | 9 | |
| 48878-3130-4 | Clinpro 5000 | 1 in 1 BOX | PASTE, DENTIFRICE | 1 | 9 | |
| 48878-3140-4 | Clinpro 5000 | 113 g in 1 TUBE | PASTE, DENTIFRICE | 113 | 9 | |
| 48878-3140-4 | Clinpro 5000 | 1 in 1 BOX | PASTE, DENTIFRICE | 1 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 48878-3120 | CLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [SOLVENTUM US LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240806_a20d3cf0-2e1f-4191-971e-9e47936b4580.zip |
| 48878-3130 | CLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [SOLVENTUM US LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240806_a20d3cf0-2e1f-4191-971e-9e47936b4580.zip |
| 48878-3140 | CLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [SOLVENTUM US LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240806_a20d3cf0-2e1f-4191-971e-9e47936b4580.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 48878-3120-4 | GM - Gram | 48878-3120 | 84a4a8af-fbcc-4e6c-b1e7-6ef54b0f195d | 1 | 2013-02-13 |
| 48878-3130-4 | GM - Gram | 48878-3130 | 4428d093-5152-417e-98ac-fa26d1395c1e | 1 | 2015-10-02 |
| 48878-3140-4 | GM - Gram | 48878-3140 | 03d1c1cd-c7b1-4cca-a3cf-3275f12aee77 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| sodium fluoride | ACTIVE INGREDIENT | 8ZYQ1474W7 | 3 | |
| fluoride ion | ACTIVE MOIETY | Q80VPU408O | 3 | |
| carboxymethylcellulose sodium | INACTIVE INGREDIENT | K679OBS311 | 3 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| polyethylene glycol | INACTIVE INGREDIENT | 3WJQ0SDW1A | 3 | |
| saccharin sodium | INACTIVE INGREDIENT | SB8ZUX40TY | 3 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | 3 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | 3 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 3 | |
| tricalcium phosphate | INACTIVE INGREDIENT | K4C08XP666 | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Products#
Every source-derived product name is available through these pages.
- Clinpro 5000
- sodium fluoride
- fluoride ion
- Water
- Sorbitol
- Silicon Dioxide
- Glycerin
- Polyethylene Glycol, Unspecified
- Sodium Lauryl Sulfate
- Titanium Dioxide
- Carboxymethylcellulose Sodium
- Saccharin Sodium
- Tricalcium Phosphate
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48878-3120 | 48878-3120-4 |
| 48878-3130 | 48878-3130-4 |
| 48878-3140 | 48878-3140-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
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 |
|---|---|---|---|---|---|---|
| glycerin | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| sodium lauryl sulfate | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, ORALLY DISINTEGRATING / ORAL | 16 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SOLUTION / ORAL | 199 mg | ||
| sodium lauryl sulfate | SODIUM LAURYL SULFATE | 368GB5141J | GRANULE / ORAL | 12 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | PASTE, DENTIFRICE / DENTAL | 0.2 %w/w | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| sodium lauryl sulfate | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FOR SUSPENSION / ORAL | 264 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| sorbitol | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FILM COATED / ORAL | 2 mg | ||
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION / ORAL | 3480 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | POWDER, FOR SOLUTION / ORAL | 161 mg | ||
| sodium lauryl sulfate | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / ORAL | 233 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET / ORAL | 280 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| sodium lauryl sulfate | SODIUM LAURYL SULFATE | 368GB5141J | SUSPENSION / ORAL | 705 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| sodium lauryl sulfate | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, CHEWABLE / ORAL | 6 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FILM COATED / ORAL | 2 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| sodium lauryl sulfate | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FILM COATED / ORAL | 240 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET / ORAL | 337.28 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | GRANULE, FOR SOLUTION / ORAL | 5.5 mg/120ml | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| sorbitol | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Clinpro 5000 | SODIUM FLUORIDE | Solventum US LLC | a20d3cf0-2e1f-4191-971e-9e47936b4580 | 2024-08-01 | Warnings, Adverse reactions | 48878-3120-4 48878-3130-4 48878-3140-4 48878-3120 48878-3140 48878-3130 48878314004 48878313004 48878312004 d7b1ca1b-115c-4bc3-8f92-87720f77d2f0 a20d3cf0-2e1f-4191-971e-9e47936b4580 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.