Over-the-counter drug · OTC MONOGRAPH DRUG
Freshen Up (Sodium fluoride) NDC 77782-015
Sodium fluoride 24 mg/100g · Gel, Dentifrice · Dental · MKJ BRANDS LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 77782-015-13 | 77782001513 | 113 g in 1 BOTTLE (77782-015-13)Marketed from Feb 10, 2025 | |
| 77782-015-14 | 77782001514 | 141 g in 1 BOTTLE (77782-015-14)Marketed from Feb 10, 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)
- Freshen Up
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 24 mg/100g
- Dosage form
- Gel, Dentifrice
- Route
- Dental
- Labeler
- MKJ BRANDS LLCNDC labeler code 77782
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 021
- Marketing start
- Listing expires
- Identifiers
- Product ID 77782-015_56ac3138-3b52-c419-e063-6294a90a344cSPL ID 56ac3138-3b52-c419-e063-6294a90a344cSPL set ID 2dcd4816-caa5-c006-e063-6394a90ac487RxCUI 416783UNII 8ZYQ1474W7UPC 0855424008213
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
N477782001513followed by a unit qualifier and the quantityPackage 77782-0015-13. 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 helps protect against cavities
Excerpt only. Read the full label for complete information.
About NDC 77782-015
- What is NDC 77782-015?
- 77782-015 is the product NDC for Freshen Up (sodium fluoride), Sodium fluoride 24 mg/100g gel, dentifrice, listed with the FDA by MKJ BRANDS LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Freshen Up (Sodium fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- MKJ BRANDS LLC, NDC labeler code 77782. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Freshen Up?
- 3 other product NDCs are listed under this name. See all Freshen Up NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Freshen Up products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Freshen Upsodium fluoride, potassium nitrate | Sodium monofluorophosphate .76 g/100g | Gel, DentifriceDental | MKJ BRANDS LLC | 77782-005 | 77782-0005-20 |
| Freshen Upsodium fluoride, potassium nitrate | Potassium nitrate 5 g/100g; Sodium fluoride 24 mg/100g | Gel, DentifriceDental | MKJ BRANDS LLC | 77782-002 | 77782-0002-13 |
| Freshen Upsodium fluoride | Sodium fluoride 24 mg/100g | Gel, DentifriceDental | DABUR INDIA LIMITED | 87846-007 | 87846-0007-1387846-0007-14 |
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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