Over-the-counter drug · OTC MONOGRAPH DRUG

Hismile (Sodium fluoride) NDC 83013-325

Sodium fluoride .243 g/100g · Gel · Dental · HISMILE PTY LTD

NDC codes

FDA NDC Directory
Product NDC (as listed)83013-325Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83013-0325Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
83013-325-068301303250660 g in 1 BOTTLE, PUMP (83013-325-06)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 83013-325_4879a9d4-38a4-34b5-e063-6394a90a152bSPL ID 4879a9d4-38a4-34b5-e063-6394a90a152bSPL set ID 1d458ccc-8f1e-f9c8-e063-6294a90a8da4RxCUI 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

N483013032506 followed by a unit qualifier and the quantity

Package 83013-0325-06. 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.

Full label on DailyMed (opens in a new tab)

About NDC 83013-325

What is NDC 83013-325?
83013-325 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Hismile NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hismilemagically delicious flavor sodium fluoride anticavity toothpasteSodium fluoride .243 g/100gGel, DentifriceDentalHismile Pty Ltd83013-33583013-0335-06
Hismilesodium fluorideSodium fluoride .243 g/100gGelDentalHISMILE PTY LTD83013-32683013-0326-06
Hismilecandy cane flavor sodium fluoride anticavity toothpasteSodium fluoride .243 g/100gGelDentalHISMILE PTY LTD83013-32783013-0327-06
Hismilesodium fluorideSodium fluoride .243 g/100gGelDentalHISMILE PTY LTD83013-32183013-0321-06
Hismilesodium fluorideSodium fluoride .243 g/100gGelDentalHISMILE PTY LTD83013-32283013-0322-06
Hismilesodium fluorideSodium fluoride .243 g/100gGelDentalHISMILE PTY LTD83013-32383013-0323-06
Hismilegrape bubblegum flavor sodium fluoride anticavity toothpasteSodium fluoride 2.4 mg/gGelDentalHismile Pty Ltd83013-31783013-0317-06
Hismilestrawberry flavor sodium fluoride anticavity toothpasteSodium fluoride 2.4 mg/gGelDentalHismile Pty Ltd83013-31883013-0318-06
Hismilevanilla flavor sodium fluoride anticavity toothpasteSodium fluoride 2.4 mg/gGelDentalHismile Pty Ltd83013-32083013-0320-06
Hismilecoconut whip flavor sodium fluoride anticavity toothpasteSodium fluoride 2.4 mg/gGelDentalHismile Pty Ltd83013-31283013-0312-06

All 17 Hismile NDCs

Other NDCs under M 021

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 021
ProductStrengthForm · routeLabelerProduct NDC
Pepsodent Complete Care Originalsodium fluorideSodium fluoride 2.4 mg/gPaste, DentifriceDentalChurch & Dwight Co., Inc.10237-651
Colgate Total SF Clean Mintstannous fluorideStannous fluoride 1.1 mg/gPaste, DentifriceDentalColgate-Palmolive Company35000-172
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartarsodium monofluorophosphateSodium monofluorophosphate 1.4 mg/gPaste, DentifriceDentalTom's of Maine, Inc.51009-202
DG health Sensitive Maximum Strengthpotassium nitrate, sodium fluorideSodium fluoride .24 g/100g; Potassium nitrate 5 g/100gPaste, DentifriceDentalDolgencorp, LLC55910-360
Freshen Upsodium fluorideSodium fluoride 24 mg/100gGel, DentifriceDentalMKJ BRANDS LLC77782-015
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoridesodium fluorideSodium fluoride 2 mg/10mLRinseDentalColgate Oral Pharmaceuticals, Inc.0126-0032
Colgate MaxFresh Citrus Freshsodium fluorideSodium fluoride 1.1 mg/gGel, DentifriceDentalColgate-Palmolive Company35000-137
Crest Complete Plus Scope Outlast Ultrasodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceDentalThe Procter & Gamble Manufacturing Company69423-918
evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINTsodium fluorideSodium fluoride .24 g/100gPaste, DentifriceDentalAshtel Studios, Inc.70108-204
Anticavity Fluoride Rinsesodium fluorideSodium fluoride .2 mg/mLMouthwashOralNice-Pak Products, LLC11344-004
Colgate MaxFresh Watermelon Blastsodium fluorideSodium fluoride 1.1 mg/gGel, DentifriceDentalColgate-Palmolive Company35000-138
Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINTsodium fluorideSodium fluoride .24 g/100gPaste, DentifriceDentalAshtel Studios, Inc.70108-205
Colgate Total SF Advanced Deep Cleanstannous fluorideStannous fluoride 1.1 mg/gPaste, DentifriceDentalColgate-Palmolive Company35000-169
Crest Pro-Health Advanced Gum Restore Deep Cleanstannous fluorideStannous fluoride 1.4 mg/gPaste, DentifriceDentalThe Procter & Gamble Manufacturing Company69423-925
Brush Buddies Oral Rinse Sparkle Mintsodium fluorideSodium fluoride .2 mg/mLMouthwashDentalASHTEL STUDIOS, INC70108-206
Enamur Fluoride AntiCavity Toothpastfluoride toothpastSodium fluoride 1.4 mg/gPaste, DentifriceOralProtegera, Inc83610-1050
Watermelon Flavor Sodium Fluoride Anticavity Toothpastsodium fluorideSodium fluoride .243 g/100gGelTopicalHISMILE PTY LTD83013-337
Meijer Restore and Defend Sensitivestannous fluorideStannous fluoride .15 g/100gPaste, DentifriceDentalMeijer Distribution Inc41250-530
Crest 4in1sodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceDentalThe Procter & Gamble Manufacturing Company69423-852
AutoBrush kids strawberrysodium fluorideSodium fluoride .243 g/100mLLiquidOralLander Enterprises, LLC82913-009

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Hismile NDC 83013-325 | National Drug Code | Med-Code