Over-the-counter drug · OTC MONOGRAPH DRUG
Hismile NDC 83013-313
mango sorbet flavor sodium fluoride anticavity toothpaste · Sodium fluoride 2.4 mg/g · Gel · Dental · Hismile Pty Ltd
NDC codes
FDA NDC DirectoryProduct NDC (as listed)83013-313Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83013-0313Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83013-313-06 | 83013031306 | 60 g in 1 BOTTLE, PUMP (83013-313-06)Marketed from Jan 14, 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)
- Hismile
- Generic name (nonproprietary)
- mango sorbet flavor sodium fluoride anticavity toothpaste
- Active ingredients
- Sodium fluoride — 2.4 mg/g
- Dosage form
- Gel
- Route
- Dental
- Labeler
- Hismile Pty LtdNDC labeler code 83013
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 021
- Marketing start
- Listing expires
- Identifiers
- Product ID 83013-313_48789f49-1a80-2c86-e063-6394a90a4ca6SPL ID 48789f49-1a80-2c86-e063-6394a90a4ca6SPL set ID 0ef3f4f8-fdc4-2056-e063-6394a90a6fd7RxCUI 416783UNII 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 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
N483013031306followed by a unit qualifier and the quantityPackage 83013-0313-06. 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 83013-313
- What is NDC 83013-313?
- 83013-313 is the product NDC for Hismile, Sodium fluoride 2.4 mg/g gel, listed with the FDA by Hismile Pty Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hismile (Mango Sorbet Flavor Sodium Fluoride Anticavity Toothpaste).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- Hismile Pty Ltd, NDC labeler code 83013. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hismile?
- 16 other product NDCs are listed under this name. See all Hismile NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hismile products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hismilemagically delicious flavor sodium fluoride anticavity toothpaste | Sodium fluoride .243 g/100g | Gel, DentifriceDental | Hismile Pty Ltd | 83013-335 | 83013-0335-06 |
| Hismilesodium fluoride | Sodium fluoride .243 g/100g | GelDental | HISMILE PTY LTD | 83013-326 | 83013-0326-06 |
| Hismilecandy cane flavor sodium fluoride anticavity toothpaste | Sodium fluoride .243 g/100g | GelDental | HISMILE PTY LTD | 83013-327 | 83013-0327-06 |
| Hismilesodium fluoride | Sodium fluoride .243 g/100g | GelDental | HISMILE PTY LTD | 83013-321 | 83013-0321-06 |
| Hismilesodium fluoride | Sodium fluoride .243 g/100g | GelDental | HISMILE PTY LTD | 83013-322 | 83013-0322-06 |
| Hismilesodium fluoride | Sodium fluoride .243 g/100g | GelDental | HISMILE PTY LTD | 83013-323 | 83013-0323-06 |
| Hismilesodium fluoride | Sodium fluoride .243 g/100g | GelDental | HISMILE PTY LTD | 83013-325 | 83013-0325-06 |
| Hismilegrape bubblegum flavor sodium fluoride anticavity toothpaste | Sodium fluoride 2.4 mg/g | GelDental | Hismile Pty Ltd | 83013-317 | 83013-0317-06 |
| Hismilestrawberry flavor sodium fluoride anticavity toothpaste | Sodium fluoride 2.4 mg/g | GelDental | Hismile Pty Ltd | 83013-318 | 83013-0318-06 |
| Hismilevanilla flavor sodium fluoride anticavity toothpaste | Sodium fluoride 2.4 mg/g | GelDental | Hismile Pty Ltd | 83013-320 | 83013-0320-06 |
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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