Over-the-counter drug · OTC MONOGRAPH DRUG
Mouth Rinse (Sodium fluoride) NDC 0363-0163
Sodium fluoride .1 mg/mL · Mouthwash · Oral · Walgreen Co.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0363-0163Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0163Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0163-86 | 0036301638600363016386 | 1000 mL in 1 BOTTLE, PLASTIC (0363-0163-86)Marketed from Mar 15, 2006 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Mouth Rinse
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — .1 mg/mL
- Dosage form
- Mouthwash
- Route
- Oral
- Labeler
- Walgreen Co.NDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 021
- Marketing start
- Listing expires
- Identifiers
- Product ID 0363-0163_4aa46dbb-3e7c-cd84-e063-6394a90ad744SPL ID 4aa46dbb-3e7c-cd84-e063-6394a90ad744SPL set ID eae87899-3eba-4d50-bc31-9eaf54ff9e00RxCUI 1038904UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400363016386followed by a unit qualifier and the quantityPackage 00363-0163-86. 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 aids in the prevention of dental cavities
Excerpt only. Read the full label for complete information.
About NDC 0363-0163
- What is NDC 0363-0163?
- 0363-0163 is the product NDC for Mouth Rinse (sodium fluoride), Sodium fluoride .1 mg/mL mouthwash, listed with the FDA by Walgreen Co.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mouth Rinse (Sodium fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- Walgreen Co., NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mouth Rinse?
- 5 other product NDCs are listed under this name. See all Mouth Rinse NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mouth Rinse products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mouth Rinseeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | The Kroger Co. | 59450-901 | 59450-0901-86 |
| Mouth Rinsesodium fluoride | Sodium fluoride .1 mg/mL | MouthwashOral | Topco Associates LLC | 36800-001 | 36800-0001-86 |
| Mouth Rinseeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | United Natural Foods, Inc. dba UNFI | 41163-318 | 41163-0318-1241163-0318-7741163-0318-86 |
| Mouth Rinseeucalyptol, menthol, methyl salicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | Old East Main Co. | 55910-318 | 55910-0318-12 |
| Mouth Rinseeucalyptol, menthol, methylsalicylate, thymol | Eucalyptol .92 mg/mL + 3 more ingredients | MouthwashOral | The Kroger Co. | 30142-072 | 30142-0072-1230142-0072-7730142-0072-86 |
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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