NDC codes

FDA NDC Directory
Product NDC (as listed)11527-420Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11527-0420Add 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
11527-420-4511527042045115270420451 TUBE in 1 CARTON (11527-420-45) / 141 g in 1 TUBEMarketed from May 15, 2017

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)
Dr. Sheffield Sensitive Care
Generic name (nonproprietary)
sensitive tooth paste
Active ingredients
Potassium nitrate — 50 mg/g
Dosage form
Paste, Dentifrice
Route
Oral
Labeler
Sheffield Pharmaceuticals LLCNDC labeler code 11527
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 022
Marketing start
Listing expires
Identifiers
Product ID 11527-420_1dbaf50f-34ac-4468-80c8-49e58ee2f07dSPL ID 1dbaf50f-34ac-4468-80c8-49e58ee2f07dSPL set ID 702a0dec-64cf-4834-8d80-f3d4f0c08a3aRxCUI 312544UNII RU45X2JN0Z

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N411527042045 followed by a unit qualifier and the quantity

Package 11527-0420-45. 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)

Drug Fact

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11527-420

What is NDC 11527-420?
11527-420 is the product NDC for Dr. Sheffield Sensitive Care (sensitive tooth paste), Potassium nitrate 50 mg/g paste, dentifrice, listed with the FDA by Sheffield Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dr. Sheffield Sensitive Care (Sensitive Tooth Paste).
What is the active ingredient?
Potassium nitrate.
Who is the labeler?
Sheffield Pharmaceuticals LLC, NDC labeler code 11527. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dr. Sheffield Sensitive Care?
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
Oral Gel Oral Pain Reliefbenzocaine benzalkonium chlorideBenzocaine 20 g/100g; Benzalkonium chloride .1 g/100gGelTopicalSavvy Care and Cosmetics83650-101
Boka Sensitivepotassium nitratePotassium nitrate 5 g/100gPaste, DentifriceDentalKaraka LLC87161-444
Sensodyne Pronamel Gentle Whitening Advancedpotassium nitrate and sodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/gPasteDentalHaleon US Holdings LLC0135-0580
Lolleez Variety PackpectinPectin 11.5 mg/7gLozengeOralBFY LLC72427-3195
UltraCare Anesthetic GelbenzocaineBenzocaine 200 mg/gGelDental, Periodontal, TopicalThe Bellport Company, Inc. dba Gingi-Pak10129-071
Chloraseptic Childrens Sore Throat CherryphenolPhenol 1.4 g/100mLSprayOralPrestige Brands Holdings, Inc.67172-930
Quality ChoicebenzocaineBenzocaine 200 mg/gGelTopicalChain Drug Marketing Association, Inc.83324-299
Chloraseptic Sore Throat Maxphenol and glycerinPhenol 15 mg/mL; Glycerin 330 mg/mLSprayOralPrestige Brands Holdings, Inc.67172-937
Orajel 3X Medicated For Toothache and Gumbenzocaine, menthol, zinc chlorideMenthol 2.6 mg/g + 2 more ingredientsGelTopicalChurch & Dwight Co., Inc.10237-790
SENSODYNE Rapid Reliefstannous fluorideStannous fluoride 1.1 mg/gPasteOralHaleon US Holdings LLC0135-0622
Antisepticeucalyptol, menthol, methyl salicylate, thymolEucalyptol .92 mg/mL + 3 more ingredientsLiquidOralWALMART INC. (see also Equate)79903-151
Pearson Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalPearson Dental Supplies INC.43305-0008
Mucinex Instasoothe Sore Throat Plus Pain Reliefbenzocaine and menthol, unspecified formBenzocaine 7 g/100mL; Menthol, Unspecified form 1 g/100mLSprayOralReckitt Benckiser LLC72854-265
HEB Extra WhiteningfluorideSodium fluoride .15 g/100g; Potassium nitrate 5 g/100gPaste, DentifriceDentalHEB37808-961
Pearson Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalPearson Dental Supplies INC.43305-0005
Mucinex Instasoothe Sore Throat Plus Pain ReliefhexylresorcinolHexylresorcinol 2 mg/1LozengeOralReckitt Benckiser LLC72854-262
Crest Scope Originalcetylpyridinium chlorideCetylpyridinium chloride .014 g/mLRinseOralThe Procter & Gamble Manufacturing Company84126-602
Pearson Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalPearson Dental Supplies INC.43305-0006
HurriCaine Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDental, Oral, PeriodontalBeutlich Pharmaceuticals, LLC0283-0920
Pearson Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDentalPearson Dental Supplies INC.43305-0007

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