Over-the-counter drug · OTC MONOGRAPH DRUG
Sodium Fluoride (Clear mint, gel toothpaste) NDC 67777-180
Sodium fluoride 220 mg/g · Gel · Dental · Dynarex Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67777-180-03 | 67777018003 | 720 BOX in 1 CASE (67777-180-03) / 144 TUBE in 1 BOX (67777-180-02) / 17 g in 1 TUBE (67777-180-01)Marketed from Jul 16, 2024 | |
| 67777-180-06 | 67777018006 | 60 BOX in 1 CASE (67777-180-06) / 1 TUBE in 1 BOX (67777-180-05) / 130 g in 1 TUBE (67777-180-04)Marketed from Jul 16, 2024 | |
| 67777-180-08 | 67777018008 | 144 TUBE in 1 CASE (67777-180-08) / 42.5 g in 1 TUBE (67777-180-07)Marketed from Jul 16, 2024 | |
| 67777-180-11 | 67777018011 | 720 BOX in 1 CASE (67777-180-11) / 144 TUBE in 1 BOX (67777-180-10) / 24 g in 1 TUBE (67777-180-09)Marketed from Jul 16, 2024 |
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)
- Sodium Fluoride
- Generic name (nonproprietary)
- clear mint, gel toothpaste
- Active ingredients
- Sodium fluoride — 220 mg/g
- Dosage form
- Gel
- Route
- Dental
- Labeler
- Dynarex CorporationNDC labeler code 67777
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 021
- Marketing start
- Listing expires
- Identifiers
- Product ID 67777-180_1be193b6-4c08-4f0a-e063-6394a90a32c7SPL ID 1be193b6-4c08-4f0a-e063-6394a90a32c7SPL set ID 1be193b6-4c07-4f0a-e063-6394a90a32c7RxCUI 245598UNII 8ZYQ1474W7UPC 0840117336926, 0840117336957, 0840117336995, 0840117337015
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N467777018003followed by a unit qualifier and the quantityPackage 67777-0180-03. 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(s) Helps protect against cavities
Excerpt only. Read the full label for complete information.
About NDC 67777-180
- What is NDC 67777-180?
- 67777-180 is the product NDC for Sodium Fluoride, Sodium fluoride 220 mg/g gel, listed with the FDA by Dynarex Corporation. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Fluoride (Clear Mint, Gel Toothpaste).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- Dynarex Corporation, NDC labeler code 67777. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Fluoride?
- 5 other product NDCs are listed under this name. See all Sodium Fluoride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sodium Fluoride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| sodium fluoride | Sodium fluoride .1 mg/mL | MouthwashOral | Lidl US, LLC | 71141-576 | 71141-0576-86 |
| Sodium fluoride | Sodium fluoride .2 mg/mL | MouthwashOral | Demoulas Super Markets, Inc | 53942-581 | 53942-0581-86 |
| Sodium Fluoride | Sodium fluoride 2.43 mg/g | Paste, DentifriceDental | Safco Dental Supply LLC | 67239-0226 | 67239-0226-00 |
| Sodium Fluoride | Sodium fluoride 2.43 mg/g | Paste, DentifriceDental | Safco Dental Supply LLC | 67239-0227 | 67239-0227-00 |
| Sodium Fluoride | Sodium fluoride .5 mg/mL | Solution/ dropsOral | Method Pharmaceuticals, LLC | 58657-322 | 58657-0322-50 |
Other NDCs under M 021
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 Everyday Value Cavity Fighting and Whiteningsodium monoflourophosphate | Sodium monofluorophosphate .13 g/100g | Paste, DentifriceDental | Whole Foods Market, Inc. | 42681-5002 |
| 365 Everyday Value Kids Flouridesodium monofluorophosphate | Sodium monofluorophosphate .13 g/100g | Paste, DentifriceDental | Whole Foods Market, Inc. | 42681-5276 |
| 3ECARE Dual FormulaToothpastefor sensitiveteethpotassium nitrate sodium monofluorophosphate | Potassium nitrate 5 g/100g; Sodium monofluorophosphate 5 g/100g | Paste, DentifriceDental | Hangzhou Namei Zhikang Technology Co., Ltd. | 87514-004 |
| 3ECARE Dual FormulaWhiteningToothpastesodium fluoride | Sodium fluoride .155 g/100g | Paste, DentifriceDental | Hangzhou Namei Zhikang Technology Co., Ltd. | 87514-003 |
| A and H Plus Therabreath Breath Freshnerssodium fluoride | Sodium fluoride .243 g/100g | Paste, DentifriceOral | Church & Dwight Co., Inc. | 10237-676 |
| ACT Anticavity Fluoride Arctic Blastsodium fluoride | Sodium fluoride .2 mg/mL | MouthwashTopical | Chattem, Inc. | 41167-0937 |
| ACT Anticavity Fluoride Cinnamonsodium fluoride | Sodium fluoride .2 mg/mL | RinseTopical | Chattem, Inc. | 41167-0940 |
| ACT Anticavity Fluoride Kids Bubblegumsodium fluoride | Sodium fluoride .2 mg/mL | RinseTopical | Chattem, Inc. | 41167-0944 |
| ACT Anticavity Fluoride Kids Groovy Grapesodium fluoride | Sodium fluoride .2 mg/mL | RinseTopical | Chattem, Inc. | 41167-0945 |
| ACT Anticavity Fluoride Kids Wild Watermelonsodium fluoride 0.24 (0.14 w/v fluoride ion) | Sodium fluoride 1.4 mg/g | PasteTopical | Chattem, Inc. | 41167-0924 |
| ACT Anticavity Fluoride Mintsodium fluoride | Sodium fluoride .2 mg/mL | RinseTopical | Chattem, Inc. | 41167-0942 |
| ACT Kids Anticavity Fluoride Bubble Gum Blowoutsodium fluoride | Sodium fluoride 1.4 mg/g | PasteTopical | Chattem, Inc. | 41167-0922 |
| ACT Kids Anticavity Fluoride Groovy Grapesodium fluoride | Sodium fluoride 1.4 mg/g | Paste, DentifriceTopical | Chattem, Inc. | 41167-0926 |
| ACT Kids Anticavity Fluoride Pineapple Punchsodium fluoride | Sodium fluoride .2 mg/mL | MouthwashTopical | Chattem, Inc. | 41167-0953 |
| ACT Kids Anticavity Fluoride Wild Watermelonsodium fluoride | Sodium fluoride .5 mg/mL | RinseTopical | Chattem, Inc. | 41167-0938 |
| ACT Kids Berry Blastsodium fluoride | Sodium fluoride .5 mg/mL | RinseOral | Chattem, Inc. | 41167-0976 |
| ACT Kids Pure Protect Anticavity- Simply Strawberrysodium fluoride | Sodium fluoride .5 mg/mL | RinseOral | Chattem, Inc. | 41167-0915 |
| ACT Restoring Anticavity Fluoride Cool Mintsodium fluoride | Sodium fluoride .2 mg/mL | MouthwashTopical | Chattem, Inc. | 41167-0957 |
| ACT Restoring Anticavity Fluoride Cool Mintsodium fluoride | Sodium fluoride .09 mg/mL | MouthwashTopical | Chattem, Inc. | 41167-0981 |
| ACT Restoring Anticavity Fluoride Mint Burstsodium fluoride | Sodium fluoride .2 mg/mL | MouthwashOral | Chattem, Inc. | 41167-0978 |
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