NDC codes

FDA NDC Directory
Product NDC (as listed)11527-062Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11527-0062Add 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
11527-062-47115270062471 TUBE in 1 CARTON (11527-062-47) / 9.35 g in 1 TUBEMarketed from Jan 30, 2006

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)
Sheffield Pain Relief
Generic name (nonproprietary)
benzocaine
Active ingredients
Benzocaine — 200 mg/g
Dosage form
Gel
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
Other FDA classes
Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)
Identifiers
Product ID 11527-062_2782a87e-5b11-4ee5-8649-3f31a52d4bdaSPL ID 2782a87e-5b11-4ee5-8649-3f31a52d4bdaSPL set ID e21abfdd-373d-42af-9535-fe1571382a65RxCUI 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 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

N411527006247 followed by a unit qualifier and the quantity

Package 11527-0062-47. 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 temporary relief of occasional minor irritation, pain and sore mouth

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11527-062

What is NDC 11527-062?
11527-062 is the product NDC for Sheffield Pain Relief (benzocaine), Benzocaine 200 mg/g gel, 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?
Sheffield Pain Relief (Benzocaine).
What is the active ingredient?
Benzocaine.
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 Sheffield Pain Relief?
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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