Over-the-counter drug · OTC MONOGRAPH DRUG
4-in-1 Teeth Care Pens NDC 83778-011
Sodium fluoride .25 g/100g · Gel, Dentifrice · Topical · Jiangxi Dentalbright Technology Co., Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83778-011-01 | 8377800110183778001101 | 2 g in 1 TUBE (83778-011-01)Marketed from Oct 30, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- 4-in-1 Teeth Care Pens
- Generic name (nonproprietary)
- 4-in-1 teeth care pens
- Active ingredients
- Sodium fluoride — .25 g/100g
- Dosage form
- Gel, Dentifrice
- Route
- Topical
- Labeler
- Jiangxi Dentalbright Technology Co., LtdNDC labeler code 83778
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Identifiers
- Product ID 83778-011_3f872924-0c45-267b-e063-6394a90a1a67SPL ID 3f872924-0c45-267b-e063-6394a90a1a67SPL set ID 3f872924-0c44-267b-e063-6394a90a1a67UNII 8ZYQ1474W7
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N483778001101followed by a unit qualifier and the quantityPackage 83778-0011-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Use Those who want to clean and whiten their teeth.
Excerpt only. Read the full label for complete information.
About NDC 83778-011
- What is NDC 83778-011?
- 83778-011 is the product NDC for 4-in-1 Teeth Care Pens, Sodium fluoride .25 g/100g gel, dentifrice, listed with the FDA by Jiangxi Dentalbright Technology Co., Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- 4-in-1 Teeth Care Pens.
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- Jiangxi Dentalbright Technology Co., Ltd, NDC labeler code 83778. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for 4-in-1 Teeth Care Pens?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 022
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavityfluoride | Fluoride ion .1 mg/mL | MouthwashOral | WHOLE FOODS | 42681-0048 |
| 3ECARE Dual formula WhiteningToothpaste Refillsodium fluoride | Sodium fluoride .155 g/100g | OintmentSubgingival | Hangzhou Namei Zhikang Technology Co., Ltd. | 87514-002 |
| 3x Medicated Mouth Sore Gelbenzocaine | Zinc chloride .15 g/100g + 2 more ingredients | GelOral | Walgreens | 0363-1605 |
| 3X Medicated Mouth Sore Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-6170 |
| 3x Medicated Mouth Sore Gelbenzocaine | Menthol, Unspecified form .1 g/100g + 2 more ingredients | GelOral | HEB | 37808-691 |
| 3x Medicated Mouth Sore Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | CVS | 69842-660 |
| 3x Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | CVS | 69842-693 |
| 4X Medicated Severe Toothache and Gum Creambenzocaine | Benzocaine 20 g/100g + 3 more ingredients | CreamOral | Rite Aid | 11822-0614 |
| 4X Medicated Severe Toothache and Gum Gelbenzocaine | Benzalkonium chloride .13 g/100g + 3 more ingredients | GelOral | Rite Aid | 11822-0615 |
| 4x Medicated Toothache and Gum Creambenzocaine | Benzocaine 20 g/100g + 3 more ingredients | CreamOral | HEB | 37808-116 |
| 4x Medicated Toothache and Gum Creambenzocaine | Benzalkonium chloride .13 g/100g + 3 more ingredients | CreamOral | CVS | 69842-631 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Menthol, Unspecified form .5 g/100g + 3 more ingredients | GelOral | Walgreens | 0363-6008 |
| 4X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 3 more ingredients | GelOral | Walmart | 49035-569 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 3 more ingredients | Gel, DentifriceOral | Publix Super Markets INC | 56062-312 |
| 4x Medicated Toothache and Gum Gelbenzocaine | Benzalkonium chloride .13 g/100g + 3 more ingredients | GelOral | CVS | 69842-642 |
| 7 Select Oral Pain Maximum Strength Reliefbenzocaine | Benzocaine 200 mg/g | GelTopical | 7-ELEVEN, INC. | 10202-853 |
| ABC Sore Throat Menthol Flavorphenol | Phenol 1.4 g/100mL | SprayOral | AMERISOURCE BERGEN | 46122-749 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | NuCare Pharmaceuticals,Inc. | 68071-4860 |
| Advance Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | The Atlanta Dental Supply Company DBA Advanced Dental Products | 71347-100 |
| Advance Topical Anesthetic Gelbenzocaine | Benzocaine 200 mg/g | GelDental | The Atlanta Dental Supply Company DBA Advanced Dental Products | 71347-101 |
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