Over-the-counter drug · OTC MONOGRAPH DRUG

Burkhart (Stannous fluoride) NDC 43498-250

Stannous fluoride .116 g/120g · Gel · Dental · Burkhart Dental Supply Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)43498-250Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43498-0250Add 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
43498-250-0443498025004120 g in 1 TUBE (43498-250-04)Marketed from Sep 1, 2013

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)
Burkhart
Generic name (nonproprietary)
stannous fluoride
Active ingredients
Stannous fluoride — .116 g/120g
Dosage form
Gel
Route
Dental
Labeler
Burkhart Dental Supply IncNDC labeler code 43498
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 022
Marketing start
Listing expires
Identifiers
Product ID 43498-250_2b483c18-3a2d-1701-e063-6294a90a3f49SPL ID 2b483c18-3a2d-1701-e063-6294a90a3f49SPL set ID 048c9978-e32e-4f77-9a4e-40acd5fcdfafUNII 3FTR44B32Q

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

N443498025004 followed by a unit qualifier and the quantity

Package 43498-0250-04. 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)

Uses: Home Care is a stable, water-free fluoride gel for home use. Aids in the prevention of dental decay.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43498-250

What is NDC 43498-250?
43498-250 is the product NDC for Burkhart (stannous fluoride), Stannous fluoride .116 g/120g gel, listed with the FDA by Burkhart Dental Supply Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Burkhart (Stannous Fluoride).
What is the active ingredient?
Stannous fluoride.
Who is the labeler?
Burkhart Dental Supply Inc, NDC labeler code 43498. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Burkhart?
13 other product NDCs are listed under this name. See all Burkhart 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 Burkhart NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Burkhartstannous fluorideStannous fluoride .3408 g/284gConcentrateDentalBurkhart Dental Supply Inc43498-20043498-0200-10
Burkhartstannous fluorideStannous fluoride .3408 g/284gConcentrateDentalBurkhart Dental Supply Inc43498-20143498-0201-10
Burkhartstannous fluorideStannous fluoride .116 g/120gGelDentalBurkhart Dental Supply Inc43498-25143498-0251-04
Burkhartsodium fluorideSodium fluoride 5.6 g/454gGelDentalBurkhart Dental Supply Inc43498-10043498-0100-15
Burkhartsodium fluorideSodium fluoride 5.6 g/454gGelDentalBurkhart Dental Supply Inc43498-10143498-0101-15
Burkhartsodium fluorideSodium fluoride 5.6 g/454gGelDentalBurkhart Dental Supply Inc43498-10243498-0102-15
Burkhartsodium fluorideSodium fluoride 5.6 g/454gGelDentalBurkhart Dental Supply Inc43498-10343498-0103-15
Burkhartsodium fluorideSodium fluoride 5.6 g/454gGelDentalBurkhart Dental Supply Inc43498-10443498-0104-15
Burkhartsodium fluorideSodium fluoride 5.6 g/454gGelDentalBurkhart Dental Supply Inc43498-10543498-0105-15
Burkhartsodium fluorideSodium fluoride 5.6 g/454gGelDentalBurkhart Dental Supply Inc43498-10643498-0106-15

All 14 Burkhart NDCs

Other NDCs under M 022

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

FDA NDC Directory listings under M 022
ProductStrengthForm · routeLabelerProduct NDC
Alpha-Caine Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDental, PeriodontalDental Technologies, Inc.55346-2903
LISTERINE Original Antisepticeucalyptol, menthol, unspecified form, methyl salicylate, and thymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralKenvue Brands LLC69968-0400
Lolleez WatermelonpectinPectin 11.5 mg/7gLozengeOralBFY LLC72427-3295
meijer Sensitive FRESH MINTpotassium nitrate, sodium fluoridePotassium nitrate 5 g/100g; Sodium fluoride .24 g/100gPaste, DentifriceDentalMeijer, Inc.79481-0039
parodontax Active Gum Repair Whiteningstannous fluorideStannous fluoride 1.1 mg/gPasteDentalHaleon US Holdings LLC0135-0638
Opalescence Sensitivity Relief Whiteningpotassium nitrate and sodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/gGel, DentifriceDentalUltradent Products, Inc.51206-308
Sensitivity Relief Fluoride Freepotassium nitratePotassium nitrate 50 mg/gPaste, DentifriceDentalHealth and Natural Beauty USA Corp63404-2105
Sucrets Sore Throat Wild Cherrydyclonine hydrochlorideDyclonine hydrochloride 2 mg/1LozengeOralInsight Pharmaceuticals LLC63736-560
BencoCaine Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalBenco Dental66975-356
Lemon GlyceringlycerinGlycerin .3 g/4gSwabOralDynarex Corporation67777-161
Anesgerm LA MUELA Fast Pain Reliefbenzocaine 20%Benzocaine 200 mg/mLLiquidTopicalGerma Products, LLC73635-7101
SENSODYNE PRONAMEL Intensive Enamel Repair Extra Freshpotassium nitrate and sodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/gPasteOralHaleon US Holdings LLC0135-0486
UltraCare Anesthetic GelbenzocaineBenzocaine 200 mg/gGelDental, Periodontal, TopicalThe Bellport Company, Inc. dba Gingi-Pak10129-071
Opal by Opalescence Sensitivitypotassium nitrate and sodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/gGel, DentifriceDentalUltradent Products, Inc.51206-311
Alpha-Caine Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDental, PeriodontalDental Technologies, Inc.55346-2901
Sensitivity and Gum with Cavity Protectionpotassium nitrate and sodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 7.6 mg/gPaste, DentifriceDentalHealth and Natural Beauty USA Corp63404-2210
Sucretsdyclonine hcl, menthol, and pectinDyclonine hydrochloride 2 mg/1 + 2 more ingredientsLozengeOralInsight Pharmaceuticals LLC63736-567
BencoCaine Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalBenco Dental66975-357
Sore Mouth Cleanserhydrogen peroxideHydrogen peroxide 150 mg/10mLMouthwashTopicalCVS Pharmacy, Inc.69842-008
Lolleez Variety PackpectinPectin 11.5 mg/7gLozengeOralBFY LLC72427-3195

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