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 coatedOralBetter Living Brands, LLC21130-45321130-0453-07
Nasal Decongestant PEphenylephrine hclPhenylephrine hydrochloride 10 mg/1Tablet, Film coatedOralH E B37808-45337808-0453-23

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
Nighttime Cold and Flu Multi Symptom Reliefacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralShield Pharmaceuticals Corp83059-0177
Revasol Acetaminophen SuspensionacetaminophenAcetaminophen 160 mg/5mLLiquidOralRnv LLC84379-311
Curewell Tussin DMdextromethorphan, guaifenesinDextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mLLiquidOralRMT HEALTH LLC85111-802
Sinus Congestion and Pain Maximum Strengthacetaminophen, phenylephrine hclAcetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1TabletOralRugby Laboratories0536-1289
Dometusschlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochlorideChlorpheniramine maleate 2 mg/5mL + 2 more ingredientsLiquidOralDomel Laboratories53809-222
Night Time Multi-Symptom Cold and Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralDiscount Drug Mart53943-603
GeriCare Tussin DM Maxdextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mLLiquidOralGERI-CARE PHARMACEUTICALS, CORP57896-591
Childrens Giltuss Honey Cough and Chest Congestiondextromethorphan hbr, guaifenesinGuaifenesin 100 mg/5mL; Dextromethorphan hydrobromide 10 mg/5mLSolutionOralGil Pharmaceutical Corp58552-141
Mucinex Childrens Coughdextromethorphan hydrobromide and guaifenesinDextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mLSolutionOralReckitt Benckiser LLC63824-946
Tussin Cough DM Sugar Freedextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mLLiquidOralQUALITY CHOICE (Chain Drug Marketing Association)63868-869
Allergy Sinus, Lil Drug Storeacetaminophen, phenylephrine hydrochloride, chlorpheniramine maleateAcetaminophen 325 mg/1 + 2 more ingredientsTabletOralLil' Drug Store Products, Inc.66715-9927
Daytime Cold and Flu Maximum Strengthacetaminophen, dextromethorphan hbr, phenylephrine hclAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralShield Pharmaceuticals Corp83059-0178
Sinus Decongestionpseudoephedrine hclPseudoephedrine hydrochloride 30 mg/1Tablet, Film coatedOralKroger Company30142-641
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBrPhenylephrine hydrochloride 5 mg/1 + 3 more ingredientsCapsule, Liquid filledOralSoftgel Healthcare Pvt Ltd35916-0166
Mucus Relief Sinus Severe Congestion and Painacetaminophen, guaifenesin, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsTablet, CoatedOralAMERISOURCE BERGEN46122-712
CVS Health Sinusoxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalCVS PHARMACY, INC.69842-715
CVS PHARMACY Childrens Cold and Allergybrompheniramine maleateBrompheniramine maleate 2 mg/10mLLiquidOralCVS PHARMACY, INC.51316-693
The Original Natural Herb Cough DropsmentholMenthol 4.8 mg/1LozengeOralRicola Ag54305-175
Sinus Pressure and Painacetaminophen, phenylephrine hclAcetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1TabletOralFamily Dollar Services Inc55319-702
Giltuss Severe Sinusoxymetazoline hclOxymetazoline hydrochloride .05 g/100mLSprayNasalGil Pharmaceutical Corp58552-142

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