Over-the-counter drug · OTC MONOGRAPH DRUG

Nasal Decongestant PE (Phenylephrine hydrochloride) NDC 80513-789

Phenylephrine hydrochloride 10 mg/1 · Tablet · Oral · Advanced Rx LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80513-789Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80513-0789Add 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
80513-789-0180513078901100 TABLET in 1 BOTTLE (80513-789-01)Marketed from Jun 1, 2025

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)
Nasal Decongestant PE
Generic name (nonproprietary)
phenylephrine hydrochloride
Active ingredients
Phenylephrine hydrochloride — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Advanced Rx LLCNDC labeler code 80513
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 012
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha1-Agonists (Mechanism)
Identifiers
Product ID 80513-789_5c235464-c070-db41-e063-6294a90ad34aSPL ID 5c235464-c070-db41-e063-6294a90ad34a
Pharmacologic class
alpha-1 Adrenergic Agonist

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

N480513078901 followed by a unit qualifier and the quantity

Package 80513-0789-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 80513-789

What is NDC 80513-789?
80513-789 is the product NDC for Nasal Decongestant PE (phenylephrine hydrochloride), Phenylephrine hydrochloride 10 mg/1 tablet, listed with the FDA by Advanced Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nasal Decongestant PE (Phenylephrine hydrochloride).
What is the active ingredient?
Phenylephrine hydrochloride.
Who is the labeler?
Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nasal Decongestant PE?
7 other product NDCs are listed under this name. See all Nasal Decongestant PE NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nasal Decongestant PE NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nasal Decongestant PEphenylephrine hydrochloridePhenylephrine hydrochloride 10 mg/1TabletOralHHH Pharmaceuticals83586-16083586-0160-01
Nasal Decongestant PEphenylephrine hydrochloridePhenylephrine hydrochloride 10 mg/1TabletOralBi-Mart37835-65137835-0651-0137835-0651-36
Nasal Decongestant PEphenylephrine hcl 10 mgPhenylephrine hydrochloride 10 mg/1TabletOralNUVICARE LLC84324-01084324-0010-01
Nasal Decongestant PEphenylephrine hclPhenylephrine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-744950090-7449-00
Nasal Decongestant PEphenylephrine hclPhenylephrine hydrochloride 10 mg/1Tablet, Film coatedOralWalgreen Company0363-453100363-4531-0700363-4531-2300363-4531-44
Nasal Decongestant PEphenylephrine hclPhenylephrine hydrochloride 10 mg/1Tablet, Film coatedOralH E B37808-45337808-0453-23
Nasal Decongestant PEphenylephrine hclPhenylephrine hydrochloride 10 mg/1Tablet, Film coatedOralBetter Living Brands, LLC21130-45321130-0453-07

Other NDCs under M 012

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 012
ProductStrengthForm · routeLabelerProduct NDC
Cold and Flu HBPacetaminophen, chlorpheniramine maleateAcetaminophen 325 mg/1; Chlorpheniramine maleate 2 mg/1Tablet, Film coatedOralWALMART INC.79903-120
Equate Daytime Nighttime Vapor Ice Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate—KitWALMART INC.79903-417
Night Time Cold and Flu ReadyInCaseacetaminophen, dextromethorphan hydrobromide, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsLiquidOralP & L Development, LLC49580-0343
Sinus Severeacetaminophen, guaifenesin, phenylephrine hclAcetaminophen 325 mg/1 + 2 more ingredientsTablet, Film coatedOralL.N.K. International, Inc.50844-572
SUDAFED PE Head Congestion Plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 3 more ingredientsTablet, Film coatedOralKenvue Brands LLC50580-450
Nighttime severe cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hclDextromethorphan hydrobromide 20 mg/30mL + 3 more ingredientsLiquidOralTARGET CORPORATION11673-828
Freegells Cough Drops Menthol Cherry 30ctmentholLevomenthol 5.8 mg/1LozengeOralRL Albert & Son Inc.83002-040
SanatosmentholMenthol 5.4 mg/1LozengeOralPharmadel LLC55758-518
Pressure and Pain Plus Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsTablet, CoatedOralVALU MERCHANDISERS COMPANY63941-173
Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hclDexbrompheniramine maleate 1 mg/mL + 2 more ingredientsSyrupOralDextrum Laboratories, Inc65852-020
Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hbr and doxylamine succinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsuleOralChain Drug Consortium, LLC68016-878
Head Congestion plus Flu Severe PEacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 3 more ingredientsTablet, CoatedOralHARRIS TEETER72036-274
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttimeacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hclAcetaminophen 1000 mg/30mL + 3 more ingredientsSyrupOralHaleon US Holdings LLC0067-0114
Childrens Cough and Congestion, Childrens Cold and Cough Day, Nightdextromethorphan hbr, doxylamine succinate, guaifenesin—KitWALMART INC.79903-414
Meijer Adult MS Severe Multi-Symptom Cough Cold Fluaacetaminophen, dextromethorphan hbr and guaifenesiAcetaminophen 650 mg/20mL + 2 more ingredientsLiquidOralMEIJER DISTRIBUTION INC79481-6308
Menthol Cough DropsmentholMenthol 5.8 mg/1PastilleOralTarget Corporation Inc.82442-001
adult dm max cough and chest congestiondextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mLSolutionOralMeijer Distribution Inc41250-261
Bio-Rytusschlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochlorideChlorpheniramine maleate 2 mg/5mL + 2 more ingredientsLiquidOralAdvanced Generic Corporation45737-250
Allergy Reliefdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1TabletOralAMERISOURCE BERGEN46122-829
Cold Relief Multi-Symptomacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl—KitL.N.K. International, Inc.50844-529

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