Over-the-counter drug · OTC MONOGRAPH DRUG

Phenylephrine Hydrochloride NDC 57631-018

Phenylephrine hydrochloride 10 mg/1 · Tablet · Oral · InvaTech Pharma Solutions LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)57631-018Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57631-0018Add 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
57631-018-00576310018005763100180030000 TABLET in 1 DRUM (57631-018-00)Marketed from Jan 13, 2021

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)
Phenylephrine Hydrochloride
Generic name (nonproprietary)
phenylephrine hydrochloride
Active ingredients
Phenylephrine hydrochloride — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
InvaTech Pharma Solutions LLCNDC labeler code 57631
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 57631-018_4024f888-60d7-f820-e063-6394a90ab81dSPL ID 4024f888-60d7-f820-e063-6394a90ab81dSPL set ID b8d360fa-0d80-f6a8-e053-2a95a90a8bd4RxCUI 1049182UNII 04JA59TNSJ
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

N457631001800 followed by a unit qualifier and the quantity

Package 57631-0018-00. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 57631-018

What is NDC 57631-018?
57631-018 is the product NDC for Phenylephrine Hydrochloride, Phenylephrine hydrochloride 10 mg/1 tablet, listed with the FDA by InvaTech Pharma Solutions LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Phenylephrine Hydrochloride.
What is the active ingredient?
Phenylephrine hydrochloride.
Who is the labeler?
InvaTech Pharma Solutions LLC, NDC labeler code 57631. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Phenylephrine Hydrochloride?
107 other product NDCs are listed under this name. See all Phenylephrine Hydrochloride 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 Phenylephrine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Phenylephrine HydrochloridePhenylephrine hydrochloride 25 mg/mLSolution/ dropsOphthalmicFirst Nation Group, LLC81469-16881469-0168-0281469-0168-15
Phenylephrine HydrochloridePhenylephrine hydrochloride 100 mg/mLSolution/ dropsOphthalmicFirst Nation Group, LLC81469-16981469-0169-05
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousFresenius Kabi USA, LLC65219-38865219-0388-01
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousCaplin Steriles Limited65145-11565145-0115-25
Phenylephrine HydrochloridePhenylephrine hydrochloride 50 mg/5mLInjectionIntravenousCaplin Steriles Limited65145-11665145-0116-0165145-0116-10
Phenylephrine HydrochloridePhenylephrine hydrochloride 100 mg/10mLInjectionIntravenousCaplin Steriles Limited65145-11765145-0117-01
phenylephrine hydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousBaxter Healthcare Corporation36000-35836000-0358-25
phenylephrine hydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousBaxter Healthcare Corporation36000-36036000-0360-10
phenylephrine hydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousBaxter Healthcare Corporation36000-36236000-0362-05
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousMethod Pharmaceuticals, LLC58657-85158657-0851-26

All 108 Phenylephrine Hydrochloride NDCs

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
Cough Reliefdextromethorphan hydrobromideDextromethorphan hydrobromide 15 mg/1Capsule, Liquid filledOralAdvanced Rx LLC80513-311
TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr—KitTARGET CORPORATION82442-559
Geri-Dryl allergy reliefdiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralVerityRx83939-0683
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci—KitTARGET Corporation11673-420
Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxidePetrolatum 49 g/100g; Zinc oxide 15 g/100gCreamTopicalWelmedix LLC24330-410
topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralTopco Associates LLC36800-143
Allergy Childrensdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralH E B37808-012
Mucus Relief Cough Childrensdextromethorphan hbr, guaifensinDextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mLLiquidOralH E B37808-594
Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesinDextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1TabletOralStrategic Sourcing Services LLC49348-728
Dual Action Honey Lemon Cough Suppressant Oral AnestheticmentholMenthol 8.3 mg/1LozengeOralRicola Ag54305-323
Discount drug mart Extra Moisturizingoxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalDISCOUNT DRUG MART53943-720
Mucus ReliefguaifenesinGuaifenesin 400 mg/1TabletOralGeri-Care Pharmaceuticals, Corp57896-714
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hclAcetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mLLiquidOralHaleon US Holdings LLC0031-0101
Throat Comfort Orange Mint Cinnamon DropsmentholMenthol 3.6 mg/1LozengeOralRicola USA Inc.63667-342
Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coatedGuaifenesin 200 mg/1 + 2 more ingredientsTablet, Film coatedOralLil' Drug Store products, Inc.66715-5632
COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 3 more ingredientsCapsule, Liquid filledOralWalgreens0363-9016
Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hclAcetaminophen 650 mg/20mL + 2 more ingredientsLiquidOralWalgreens0363-9130
Pyrilamine Maleate and Dextromethorphan HydrobromideDextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mLLiquidOralWestminster Pharmaceuticals, LLC69367-398
Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hclAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralAptaPharma Inc.76281-604
Cough DropsmentholMenthol 5.8 mg/1PastilleOralTopco Associates LLC76162-016

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