Over-the-counter drug · OTC MONOGRAPH DRUG
Sodium Monofluorophosphate (White toothpaste) NDC 67777-181
Sodium monofluorophosphate 760 mg/g · Paste · Dental · Dynarex Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67777-181-02 | 6777701810267777018102 | 144 TUBE in 1 CASE (67777-181-02) / 42.5 g in 1 TUBE (67777-181-01)Marketed from Jul 16, 2024 | |
| 67777-181-04 | 6777701810467777018104 | 144 TUBE in 1 CASE (67777-181-04) / 78 g in 1 TUBE (67777-181-03)Marketed from Jul 16, 2024 | |
| 67777-181-07 | 6777701810767777018107 | 60 BOX in 1 CASE (67777-181-07) / 1 TUBE in 1 BOX (67777-181-06) / 130 g in 1 TUBE (67777-181-05)Marketed from Jul 16, 2024 | |
| 67777-181-10 | 6777701811067777018110 | 720 BOX in 1 CASE (67777-181-10) / 144 TUBE in 1 BOX (67777-181-09) / 24 g in 1 TUBE (67777-181-08)Marketed from Jul 16, 2024 | |
| 67777-181-13 | 6777701811367777018113 | 720 BOX in 1 CASE (67777-181-13) / 144 TUBE in 1 BOX (67777-181-12) / 17 g in 1 TUBE (67777-181-11)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 Monofluorophosphate
- Generic name (nonproprietary)
- white toothpaste
- Active ingredients
- Sodium monofluorophosphate — 760 mg/g
- Dosage form
- Paste
- 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 67777-181_1c58c582-92e0-4533-e063-6394a90a9fe5SPL ID 1c58c582-92e0-4533-e063-6394a90a9fe5SPL set ID 1be422b9-6320-ed5c-e063-6294a90a7e42RxCUI 545626UNII C810JCZ56QUPC 0840117337107, 0840117337084, 0840117337053, 0840117337138, 0840117337169
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
N467777018102followed by a unit qualifier and the quantityPackage 67777-0181-02. 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 67777-181
- What is NDC 67777-181?
- 67777-181 is the product NDC for Sodium Monofluorophosphate (white toothpaste), Sodium monofluorophosphate 760 mg/g paste, listed with the FDA by Dynarex Corporation. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Monofluorophosphate (White Toothpaste).
- What is the active ingredient?
- Sodium monofluorophosphate.
- 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 Monofluorophosphate?
- 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 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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