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?
109 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, LLC58657-85358657-0853-01

All 110 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
Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralWALGREENS0363-0100
CVS Health No Dripnasal mistOxymetazoline hydrochloride .05 g/100mLSprayNasalCVS PHARMACY,INC.69842-815
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONacetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromideAcetaminophen 325 mg/1 + 3 more ingredientsTablet, CoatedOralThe Procter & Gamble Manufacturing Company69423-986
Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsSolutionOralLidl US LLC71141-180
basic care tussin dm maxdextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mLSolutionOralAmazon.com Services LLC72288-293
Menthol Cough Drops Honey Vanilla FlavormentholMenthol 2.5 mg/1LozengeOralXiamen Kang Zhongyuan Biotechnology Co., Ltd.83698-013
equate daytime nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesen, phenylephrine hydrochloride—KitSixarp, LLC59368-459
Nasal Decongestant Maximum Strengthpseudoephedrine hclPseudoephedrine hydrochloride 30 mg/1Tablet, Film coatedOralBetter Living Brands, LLC21130-112
Medicated Chest Rubcamphor, menthol, eucalyptus oilCamphor (Synthetic) 4.8 g/100g + 2 more ingredientsCreamTopicalJell Pharmaceuticals Pvt Ltd.30400-701
equaline nighttime cold and flu reliefacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsSolutionOralUnited Natural Foods, Inc. dba UNFI41163-459
NiteTime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsLiquidOralEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-044
Childrens Dye Free Allergydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralP & L Development, LLC49580-0293
Discount Drug Mart Original Nasaloxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalDISCOUNT DRUG MART53943-715
Cold, Flu and Sore Throatacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hclAcetaminophen 650 mg/20mL + 3 more ingredientsSolutionOralFamily Dollar Services Inc55319-705
DG Health Cold and Flu Severeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochlorideAcetaminophen 325 mg/15mL + 3 more ingredientsSolutionOralDolgencorp Inc55910-928
Robitussin Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochlorideAcetaminophen 650 mg/20mL + 3 more ingredientsLiquidOralHaleon US Holdings LLC0031-8751
Afrin No Drip Pump Mist Bundle Packoxymetazoline hydrochloride—KitNasalBayer HealthCare LLC.11523-0147
Cold Medicine XL3acetaminophen chlorpheniramine maleate phenylepherine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsTabletOralSelder, S.A. de C.V.63654-605
Nasal Spray, 1oz, 24/7 Life by 7-Elevenoxymetazoline hcl nasal solution 0.05%Oxymetazoline hydrochloride .05 g/100mLSprayNasalLil' Drug Store Products, Inc.66715-5526
Vicks childrens Cough Congestionphenylephrine hcl, dextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 10 mg/15mL + 2 more ingredientsLiquidOralThe Procter & Gamble Manufacturing Company69423-982

Showing 20 of 40.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in