NDC codes

FDA NDC Directory
Product NDC (as listed)0135-0573Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00135-0573Add 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
0135-0573-02001350573021 TUBE in 1 CARTON (0135-0573-02) / 96.4 g in 1 TUBEMarketed from Jul 14, 2014
0135-0573-03001350573031 TUBE in 1 CARTON (0135-0573-03) / 23 g in 1 TUBEMarketed from Jul 14, 2014

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Sensodyne Complete Protection
Generic name (nonproprietary)
stannous fluoride
Active ingredients
Stannous fluoride — 1.1 mg/g
Dosage form
Paste
Route
Dental
Labeler
Haleon US Holdings LLCNDC labeler code 0135
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 022
Marketing start
Listing expires
Identifiers
Product ID 0135-0573_78b76a64-361a-41e8-aead-29ac143c0901SPL ID 78b76a64-361a-41e8-aead-29ac143c0901SPL set ID e3cc3146-8aed-4f6b-a252-e379418c2b8dRxCUI 416784UNII 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

N400135057302 followed by a unit qualifier and the quantity

Package 00135-0573-02. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Uses • aids in the prevention of dental cavities. • helps prevent gingivitis, an early form of gum disease. • helps interfere with harmful effects of plaque associated with gingivitis. • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0135-0573

What is NDC 0135-0573?
0135-0573 is the product NDC for Sensodyne Complete Protection (stannous fluoride), Stannous fluoride 1.1 mg/g paste, listed with the FDA by Haleon US Holdings LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sensodyne Complete Protection (Stannous fluoride).
What is the active ingredient?
Stannous fluoride.
Who is the labeler?
Haleon US Holdings LLC, NDC labeler code 0135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sensodyne Complete Protection?
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
Vicks VapoCool SEVERE plus Intense Pain Reliefbenzocaine and mentholBenzocaine 15 mg/1; Menthol 20 mg/1LozengeOralThe Procter & Gamble Manufacturing Company84126-366
Meijer Sore ThroatphenolPhenol 1.4 g/100mLSprayOralMEIJER DISTRIBUTION INC.41250-632
Advance Topical Anesthetic GelbenzocaineBenzocaine 200 mg/gGelDentalThe Atlanta Dental Supply Company DBA Advanced Dental Products71347-105
Anadent Kanka GelbenzocaineBenzocaine 200 mg/gGelDentalBELMORA LLC27854-177
Rexall Maximum StrengthbenzocaineBenzocaine 20 g/100mLLiquidOralRexall55910-346
HurriCaine Topical Anesthetic GelbenzocaineBenzocaine 200 mg/gGelDental, Oral, PeriodontalBeutlich Pharmaceuticals, LLC0283-0886
Orajel 3X Medicated For All Mouth Soresbenzocaine, menthol, zinc chlorideBenzocaine 200 mg/g + 2 more ingredientsGelTopicalChurch & Dwight Co., Inc.10237-783
Crest Kids Advanced Color Changingsodium monofluorophosphateSodium monofluorophosphate 1.6 mg/gPaste, DentifriceDentalProcter & Gamble Manufactura, S de R.L. de C.V.58933-012
Gelato Topical AnestheticbenzocaineBenzocaine 11.4 g/57gSpray, MeteredDentalMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc68400-323
Vicks Vapo BreathersmentholMenthol 20 mg/1LozengeOralThe Procter & Gamble Manufacturing Company84126-320
SENSODYNE PRONAMEL Active Shield Fresh Mintpotassium nitrate and sodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/gPasteOralHaleon US Holdings LLC0135-0700
Sore ThroatphenolPhenol 1.4 g/100mLSprayOralEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-376
Ludens Honey Licorice Throat DropsmentholMenthol 1.6 mg/1LozengeOralPrestige Brands Holdings, Inc.52183-255
Kaylaanzero waste refill for toothpasteSodium fluoride .37 mg/440mgTablet, ChewableDentalKaylaan LLC82091-113
Candee Caine Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalTop Quality Manufacturing, Inc.69301-061
Kaylaanzero waste refill for toothpasteSodium fluoride .37 mg/440mgTablet, ChewableDentalKaylaan LLC82091-115
Ludens Wild Cherry Throat DropspectinPectin 2.8 mg/1LozengeOralPrestige Brands Holdings, Inc.52183-229
Kaylaanzero waste refill for toothpasteSodium fluoride .37 mg/440mgTablet, ChewableDentalKaylaan LLC82091-116
SENSODYNE Sensitivity Gum and Enamel Mintstannous fluorideStannous fluoride 1.1 mg/gPasteOralHaleon US Holdings LLC0135-5022
Ludens Sugar Free Wild Cherry ThroatpectinPectin 2.8 mg/1LozengeOralPrestige Brands Holdings, Inc.52183-249

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