NDC codes

FDA NDC Directory
Product NDC (as listed)10564-0910Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10564-0910Add 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
10564-0910-2105640910021 PATCH, EXTENDED RELEASE in 1 CARTON (10564-0910-2)Marketed from Dec 1, 2015

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Dentek Canker Cover
Generic name (nonproprietary)
menthol
Active ingredients
Menthol — 2.5 mg/194.851
Dosage form
Patch, Extended release
Route
Transmucosal
Labeler
Bershtel EnterprisesNDC labeler code 10564
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 022
Marketing start
Listing expires
Identifiers
Product ID 10564-0910_47419d1d-2da5-fed5-e063-6294a90a3d13SPL ID 47419d1d-2da5-fed5-e063-6294a90a3d13SPL set ID 2669183c-7a58-037e-e054-00144ff88e88RxCUI 1725069UNII L7T10EIP3A

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

N410564091002 followed by a unit qualifier and the quantity

Package 10564-0910-02. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 10564-0910

What is NDC 10564-0910?
10564-0910 is the product NDC for Dentek Canker Cover (menthol), Menthol 2.5 mg/194.851 patch, extended release, listed with the FDA by Bershtel Enterprises. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dentek Canker Cover (Menthol).
What is the active ingredient?
Menthol.
Who is the labeler?
Bershtel Enterprises, NDC labeler code 10564. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dentek Canker Cover?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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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