Indications and uses
aids in the prevention of dental cavities
Whitening
- Manufacturer
- Target | Lornamead Products
- Effective date
- 2025-11-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 01:17:30
Label at a glance#
ProductWhitening
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections
Dosage and administration
adults and children 2 years of age and older: brush teeth thoroughly, preferably after ach meal or at least twice per day, or as directed by a dentist or doctor. instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). supervise children as necessary until capable of using without supervision. children under 2 years of age: Consult a dentist or doctor.
Label contents#
Full prescribing information#
Active ingredient
Sodium monofluorophosphate 0.76% w/w (0.14% w/v fluoride ion)
Purpose
Anticavity
Uses
aids in the prevention of dental cavities
Keep out of reach of children
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
adults and children 2 years of age and older: brush teeth thoroughly, preferably after ach meal or at least twice per day, or as directed by a dentist or doctor.
instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
supervise children as necessary until capable of using without supervision.
children under 2 years of age: Consult a dentist or doctor.
Inactive ingredients
glycerin, hydrated silica, water, sorbitol, pentasodium triphosphate, PVP, titanium dioxide, cellulose gum, flavor, cocamidopropyl betaine, sodium lauryl sulfate, potassium sorbate, sorbic acid, potassium acesulfam, sucralose, sodium hydroxide
Warnings
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Principal Display Panel
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 545626 | sodium monofluorophosphate 0.76 % Toothpaste | PSN | 6 |
| 545626 | sodium monofluorophosphate 0.0076 MG/MG Toothpaste | SCD | 6 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste | SY | 6 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste | SY | 6 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste | SY | 6 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste | SY | 6 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0085239929506 | GTIN-13: 0085239929506 EAN-13: 0085239929506 GTIN-12: 085239929506 UPC-A: 085239929506 GTIN storage (14 digits): 00085239929506 | Target_InstantWhitening_CTN_2PK_2821064R1-OL.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11673-385-08 | Whitening | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 6 | |
| 11673-385-08 | Whitening | 113 g in 1 TUBE | PASTE, DENTIFRICE | 113 | 6 | |
| 11673-385-09 | Whitening | 2 in 1 CARTON | PASTE, DENTIFRICE | 2 | 6 | |
| 11673-385-09 | Whitening | 113 g in 1 TUBE | PASTE, DENTIFRICE | 113 | 6 |
Products#
Every source-derived product name is available through these pages.
- Whitening
- Monofluorophosphate
- SORBITOL
- SODIUM HYDROXIDE
- POTASSIUM SORBATE
- HYDRATED SILICA
- SUCRALOSE
- SORBIC ACID
- SODIUM MONOFLUOROPHOSPHATE
- FLUORIDE ION
- WATER
- GLYCERIN
- TITANIUM DIOXIDE
- SODIUM LAURYL SULFATE
- COCAMIDOPROPYL BETAINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11673-385 | 11673-385-08, 11673-385-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SORBITOL | 506T60A25R | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| SODIUM MONOFLUOROPHOSPHATE | C810JCZ56Q | ACTIM |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| COCAMIDOPROPYL BETAINE | 5OCF3O11KX | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| Whitening | MONOFLUOROPHOSPHATE | Target | 0074630f-9d8d-9209-e063-6294a90a4f01 | 2025-11-21 | Warnings | 11673-385-08 11673-385-09 11673-385 11673038509 11673038508 441eb113-64d9-ceeb-e063-6394a90a2f74 0074630f-9d8d-9209-e063-6294a90a4f01 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.