NDC codes

FDA NDC Directory
Product NDC (as listed)53145-004Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53145-0004Add 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
53145-004-0153145000401531450004011 BOTTLE, SPRAY in 1 CARTON (53145-004-01) / 30 mL in 1 BOTTLE, SPRAYMarketed from Feb 21, 2012

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)
Aseptil Rojo
Generic name (nonproprietary)
phenol
Active ingredients
Phenol — 1.4 mg/100mL
Dosage form
Spray
Route
Topical
Labeler
Menper Distributors, Inc.NDC labeler code 53145
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 022
Marketing start
Listing expires
Identifiers
Product ID 53145-004_3a88920c-eeb8-7d71-e063-6294a90ac4afSPL ID 3a88920c-eeb8-7d71-e063-6294a90ac4afSPL set ID 62c96dc1-4698-43c1-8e6d-f4062dc5eea2UNII 339NCG44TVUPC 0042279132013

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N453145000401 followed by a unit qualifier and the quantity

Package 53145-0004-01. 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 for temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53145-004

What is NDC 53145-004?
53145-004 is the product NDC for Aseptil Rojo (phenol), Phenol 1.4 mg/100mL spray, listed with the FDA by Menper Distributors, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Aseptil Rojo (Phenol).
What is the active ingredient?
Phenol.
Who is the labeler?
Menper Distributors, Inc., NDC labeler code 53145. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Aseptil Rojo?
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
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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