Over-the-counter drug · OTC MONOGRAPH DRUG
Hismile (Sodium fluoride) NDC 83013-322
Sodium fluoride .243 g/100g · Gel · Dental · HISMILE PTY LTD
NDC codes
FDA NDC DirectoryProduct NDC (as listed)83013-322Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83013-0322Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83013-322-06 | 83013032206 | 60 g in 1 BOTTLE, PUMP (83013-322-06)Marketed from Jul 15, 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)
- sodium fluoride
- Active ingredients
- Sodium fluoride — .243 g/100g
- 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 83013-322_4879a08e-e779-c822-e063-6294a90a34a9SPL ID 4879a08e-e779-c822-e063-6294a90a34a9SPL set ID 1d44863e-93be-2b80-e063-6294a90a4a9dRxCUI 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
N483013032206followed by a unit qualifier and the quantityPackage 83013-0322-06. 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 83013-322
- What is NDC 83013-322?
- 83013-322 is the product NDC for Hismile (sodium fluoride), Sodium fluoride .243 g/100g 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 (Sodium Fluoride).
- 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 | 83013-323 | 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 |
| Hismilecoconut whip flavor sodium fluoride anticavity toothpaste | Sodium fluoride 2.4 mg/g | GelDental | Hismile Pty Ltd | 83013-312 | 83013-0312-06 |
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 |
|---|---|---|---|---|
| Crest 3D White Advanced Radiant Mint with Stain Blasting Foamsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 84126-629 |
| Orajel Kids Supermananticavity toothpaste | Sodium fluoride 1.5 mg/g | Gel, DentifriceDental | Church & Dwight Co., Inc. | 10237-732 |
| Dr Tichenors With Extra Whitening and Tartar Controlsodium fluoride | Sodium fluoride 2.43 mg/g | Paste, DentifriceOral | Dr. G. H. Tichenor's Antiseptic Company | 11291-243 |
| Colgate Kids Maximum Cavity Protectionsodium fluoride | Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Colgate-Palmolive | 35000-190 |
| Anticavity Fluoride Rinsesodium fluoride | Sodium fluoride .2 mg/mL | MouthwashOral | H E B | 37808-213 |
| Frida Fluoride Sweet Mintsodium fluoride | Sodium fluoride 2.2 mg/g | Paste, DentifriceDental | Fridababy, LLC | 72705-502 |
| Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartarsodium monofluorophosphate | Sodium monofluorophosphate 1.4 mg/g | Paste, DentifriceDental | Tom's of Maine, Inc. | 51009-202 |
| Crest 3D White Advanced Deep Clean with Stain-Blasting Foamsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 84126-631 |
| Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartarsodium monofluorophosphate | Sodium monofluorophosphate 1.4 mg/g | Paste, DentifriceDental | Tom's of Maine, Inc. | 51009-203 |
| Euthymol Whitening Special Gift Setsodium fluoride | — | KitDental | LG HOUSEHOLD & HEALTH CARE LTD. | 53208-574 |
| Therabreath Whiteningsodium fluoride | Sodium fluoride .243 g/100g | Paste, DentifriceOral | Church & Dwight Co., Inc. | 10237-272 |
| Colgate Maximum Cavity Protection Bubble Fruit Flavorsodium fluoride | Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Colgate-Palmolive Company | 35000-196 |
| Crest Cavity Protection Regularsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 37000-005 |
| Frida Fluoride Bubble Mintsodium fluoride | Sodium fluoride 2.2 mg/g | Paste, DentifriceDental | Fridababy, LLC | 72705-503 |
| Toms Wicked Fresh Cool Peppermint fresh breath / cavity protectionsodium monofluorophosphate | Sodium monofluorophosphate 1.4 mg/g | Paste, DentifriceDental | Tom's of Maine, Inc. | 51009-205 |
| POP Gel Pumpin Strawberrysodium fluoride | Sodium fluoride 1.3 mg/g | Paste, DentifriceDental | LG H&H Co., Ltd. | 53208-581 |
| Anticavity Fluoride Rinsesodium fluoride | Sodium fluoride .2 mg/mL | MouthwashOral | CVS Pharmacy, Inc. | 59779-004 |
| Crest 3D White Advanced Glamorous White with Stain-Blasting Foamsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceDental | The Procter & Gamble Manufacturing Company | 84126-632 |
| Osstem G Gum Health Care Toothsodium fluoride | Sodium fluoride .22 g/100g | Paste, DentifriceOral | Osstem Pharma Co., Ltd | 87548-020 |
| Colgate Kids Space Jam Mild Bubble Fruit Flavorsodium fluoride | Sodium fluoride 1.1 mg/g | Gel, DentifriceDental | Colgate-Palmolive Company | 35000-199 |
Showing 20 of 40.