Over-the-counter drug · OTC MONOGRAPH DRUG

Burkhart Topical Anesthetic (Benzocaine) NDC 43498-314

Benzocaine 200 mg/g · Gel · Dental · Burkhart Dental Supply Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)43498-314Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43498-0314Add 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
43498-314-30434980314304349803143030 g in 1 JAR (43498-314-30)Marketed from Jun 1, 2018

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 Topical Anesthetic
Generic name (nonproprietary)
benzocaine
Active ingredients
Benzocaine — 200 mg/g
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
Other FDA classes
Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)
Identifiers
Product ID 43498-314_2b482a60-20e4-e4ce-e063-6294a90ac004SPL ID 2b482a60-20e4-e4ce-e063-6294a90ac004SPL set ID 26128466-939b-445f-aa64-04c7283d306cRxCUI 238910UNII U3RSY48JW5
Pharmacologic class
Standardized Chemical Allergen

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

N443498031430 followed by a unit qualifier and the quantity

Package 43498-0314-30. 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 For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43498-314

What is NDC 43498-314?
43498-314 is the product NDC for Burkhart Topical Anesthetic (benzocaine), Benzocaine 200 mg/g 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 Topical Anesthetic (Benzocaine).
What is the active ingredient?
Benzocaine.
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 Topical Anesthetic?
9 other product NDCs are listed under this name. See all Burkhart Topical Anesthetic 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 Topical Anesthetic NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Burkhart Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalBurkhart Dental Supply Inc43498-31043498-0310-30
Burkhart Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalBurkhart Dental Supply Inc43498-31143498-0311-30
Burkhart Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalBurkhart Dental Supply Inc43498-31243498-0312-30
Burkhart Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalBurkhart Dental Supply Inc43498-31343498-0313-30
Burkhart Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalBurkhart Dental Supply Inc43498-31543498-0315-30
Burkhart Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalBurkhart Dental Supply Inc43498-31643498-0316-30
Burkhart Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalBurkhart Dental Supply Inc43498-31743498-0317-30
Burkhart Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalBurkhart Dental Supply Inc43498-31843498-0318-30
Burkhart Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalBurkhart Dental Supply Inc43498-31943498-0319-30

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
HurriCaine Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDental, Oral, PeriodontalBeutlich Pharmaceuticals, LLC0283-1820
Organic Peppermint Herb Throat DropsmentholMenthol 1.9 mg/1LozengeOralRicola USA Inc.63667-010
Equate Sculpted White TP Equate Sculpted White TPsodium fluorideSodium fluoride .15 g/100gPaste, DentifriceOralWalmart79903-282
Ki No Sincalcium carbonateCalcium carbonate 55 mg/500mgTabletOralNPG Bio Pharmaceuticals Co.,Ltd.84540-322
R B onephosphatidylserine, zinc oxideZinc oxide 6.38 mg/1100mg + 2 more ingredientsTabletOralNPG Bio Pharmaceuticals Co.,Ltd.84540-140
Sensodynepotassium nitrate and sodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/gPasteDentalHaleon US Holdings LLC0135-0550
parodontaxstannous fluorideStannous fluoride 1.1 mg/gPasteDentalHaleon US Holdings LLC0135-0598
CVS Health Sensitive Enamel Repairsodium fluorideSodium fluoride .15 g/100g; Potassium nitrate 5 g/100gPaste, DentifriceOralCVS51316-169
Alzh Lphosphatidylserine, magnesium oxidePhosphatidyl serine 214.43 mg/450mg + 2 more ingredientsTabletOralNPG Bio Pharmaceuticals Co.,Ltd.84540-230
TopicalebenzocaineBenzocaine 180 mg/gOintmentOralMedical Products Laboratories, Inc.10733-162
Walgreens Maximum StrengthbenzocaineBenzocaine 20 g/100gPaste, DentifriceTopicalWalgreens0363-5337
Walgreens Maximum StrengthbenzocaineBenzocaine 20 g/100gLiquidOralWalgreens0363-5820
Dem Zerophosphatidylserine, magnesium oxidePhosphatidyl serine 214.43 mg/450mg + 2 more ingredientsTabletOralNPG Bio Pharmaceuticals Co.,Ltd.84540-240
Benzoin Tincturebenzoin resinBenzoin resin 1000 mg/mLLiquidTopical11695664470677-1200
Rite Aid Maximum StrengthbenzocaineBenzocaine 20 g/100gLiquidOralRite Aid11822-0345
Chloraseptic Sore Throat CitrusphenolPhenol 1.4 g/100mLSprayOralPrestige Brands Holdings, Inc.67172-112
Sore Throat Relief Cherry FlavorphenolPhenol 1.4 g/100mLSprayOralCardinal Health70000-0458
HurriCaine Topical Anesthetic GelbenzocaineBenzocaine 200 mg/gGelDental, Oral, PeriodontalBeutlich Pharmaceuticals, LLC0283-0293
Rite Aid Professional StrengthbenzocaineBenzocaine 20 g/100gLiquidOralRite Aid11822-5340
Benzocaine 20%Benzocaine 200 mg/mLSolutionTopicalPAI Holdings, LLC dba PAI Pharma0121-1077

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