Dosage and administration
USE AS DIRECTED BY YOUR PHYSICIAN.
Ludent
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2018-08-30
- Label type
- DIETARY SUPPLEMENT
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:49:05
Label at a glance#
ProductLudent
Active ingredientSODIUM FLUORIDE
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
STATEMENT OF IDENTITY SECTION
WARNING
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222. TABLET SHOULD BE CHEWED. THIS PRODUCT, AS WITH ALL CHEWABLE TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE 4 DUE TO RISK OF CHOKING.
DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING
Directions
USE AS DIRECTED BY YOUR PHYSICIAN.
Description
White to off-white, orange flavor, round-shaped chewable tablet debossed "SCI" on one side and "4" on the other.
See inside panel for additional information
Caution
Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.
Other Ingredients
Xylitol, microcrystalline cellulose, malic acid, magnesium stearate, talc, citric acid, natural orange flavor, sucralose.
Storage
Store in a cool, dry place at room temperature 20° - 25°C (68° - 77°F) away from heat and sunlight. Store in original container.
This medical food product is formulated to be administered orally, under the ongoing supervision of a physician and is intended for the dietary management of dental caries for which a distinctive nutritional requirement of fluoride, based on recognized scientific principles, has been established by medical evaluation.
The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health-insurance and state level reimbursement programs and is not intended to denote registration with the FDA.
HEALTH CLAIM SECTION
Manufactured by: Sancilio & Co., Inc.
Riviera Beach, FL 33404 USA
rev. 12/02/11
Sodium Fluoride
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 901296 | Ludent 1 MG Chewable Tablet | PSN | 4 |
| 315213 | sodium fluoride 2.2 MG Chewable Tablet | PSN | 4 |
| 901296 | sodium fluoride 2.2 MG Chewable Tablet [Ludent] | SBD | 4 |
| 315213 | sodium fluoride 2.2 MG Chewable Tablet | SCD | 4 |
| 901296 | Ludent 2.2 MG (fluoride ion 1 MG) Chewable Tablet | SY | 4 |
| 901296 | Ludent 2.2 MG Chewable Tablet | SY | 4 |
| 315213 | sodium fluoride 2.2 MG (fluoride ion 1 MG) Chewable Tablet | SY | 4 |
| 315213 | sodium fluoride 2.21 MG (fluoride ion 1 MG) Chewable Tablet | SY | 4 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-3546-0 | Ludent | 24 in 1 BOX | TABLET, CHEWABLE | 24 | 4 | |
| 50090-3546-0 | Ludent | 120 in 1 BOTTLE | TABLET, CHEWABLE | 120 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-3546 | LUDENT (SODIUM FLUORIDE) TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS] | 4 | 2 package rows | 20180831_1de924e5-cc41-4bc9-875e-5c67b8a59e78.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 44946-1010-3 | EA - Each | 44946-1010 | e12fef13-74ec-4a80-93a8-8a032f91a522 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- Ludent
- Sodium Fluoride
- FLUORIDE ION
- Xylitol
- MICROCRYSTALLINE CELLULOSE
- Malic Acid
- Magnesium Stearate
- Talc
- Anhydrous Citric Acid
- Sucralose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-3546 | 50090-3546-0 |
| 44946-1010 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| Xylitol | VCQ006KQ1E | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| Malic Acid | 817L1N4CKP | IACT |
| Magnesium Stearate | 70097M6I30 | IACT |
| Talc | 7SEV7J4R1U | IACT |
| Anhydrous Citric Acid | XF417D3PSL | IACT |
| Sucralose | 96K6UQ3ZD4 | 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.