NDC codes

FDA NDC Directory
Product NDC (as listed)0280-1590Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00280-1590Add 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
0280-1590-20002801590202 BLISTER PACK in 1 CARTON (0280-1590-20) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jun 19, 2017

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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

Generic name (nonproprietary)
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
Active ingredients
Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 10 mg/1Phenylephrine hydrochloride — 5 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
Bayer HealthCare LLC.NDC labeler code 0280
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 012
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha1-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers
Product ID 0280-1590_45267943-6d50-45dd-e063-6294a90ab025SPL ID 45267943-6d50-45dd-e063-6294a90ab025SPL set ID 5172dc01-4e7f-3307-e054-00144ff8d46cRxCUI 1086997UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJUPC 0016500555308
Pharmacologic class
Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; 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

N400280159020 followed by a unit qualifier and the quantity

Package 00280-1590-20. 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 · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · cough · sore throat · nasal and sinus congestion · temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0280-1590

What is NDC 0280-1590?
0280-1590 is the product NDC for Alka-Seltzer Plus Maximum Strength Day Cold and Flu, Acetaminophen 325 mg/1 + 2 more ingredients capsule, liquid filled, listed with the FDA by Bayer HealthCare LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Alka-Seltzer Plus Maximum Strength Day Cold and Flu (Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride).
What is the active ingredient?
Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride.
Who is the labeler?
Bayer HealthCare LLC., NDC labeler code 0280. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Alka-Seltzer Plus Maximum Strength Day Cold and Flu?
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 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
Equate Kids Daytime Dex Cough GelsdextromethorphanDextromethorphan hydrobromide 10 mg/1Tablet, ChewableOralWalmart79903-337
Nuvicare DayTime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralNUVICARE LLC84324-018
MGC Cough DropsmentholMenthol, Unspecified form 5.4 mg/1LozengeOralMedical Group Care LLC83173-109
Pain Reliever PMacetaminophen diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralQUALITY CHOICE (Chain Drug Marketing Association)83324-166
Cough DropsmentholMenthol 7.5 mg/1PastilleOralUnited Natural Foods, Inc.83455-203
Better Livingphenylephrine hydrochloridePhenylephrine hydrochloride 1 g/100mLSprayNasalBETTER LIVING BRANDS LLC21130-728
Sinus Congestion and Pain Relief Non-Drowsy/Daytimeacetaminophen, guaifenesin and phenylephrine hclAcetaminophen 325 mg/1 + 2 more ingredientsTablet, Film coatedOralRite Aid Corporation11822-0527
nasaloxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSpray, MeteredNasalRite Aid Corporation11822-6319
Childrens Sudafed Nasal Decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 15 mg/5mLSolutionOralKenvue Brands LLC50580-536
Dye Free Wal Dryl Allergy childrensdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralWalgreens0363-0293
Childrens Giltuss Honey Cough and Chest Congestiondextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mLSolutionOralDextrum Laboratories, Inc65852-003
Severe Sinus Daytime, Non-Drowsyacetaminophen, guaifenesin, phenylephrine hclAcetaminophen 325 mg/1 + 2 more ingredientsTablet, Film coatedOralWalgreen Company0363-5027
Leader Nasal Decongestantoxymetazoline hydrochlorideOxymetazoline hydrochloride .5 mg/mLSprayNasalCardinal Health 110,Inc70000-0676
Akin Cough Formula DMdextromethorphan, guaifenesinDextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mLLiquidOralSouthern Sales & Service, Inc.69822-202
CVS Health Chest Congestion Relief PEguaifenesin/phenylephrineGuaifenesin 400 mg/1; Phenylephrine hydrochloride 10 mg/1TabletOralCVS Pharmacy, Inc.69842-997
Sinus Severeacetaminophen, guaifenesin, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsTablet, CoatedOralHarris Teeter72036-119
Cough Drops Dollar General Assorted Flavors 80ctmentholMenthol 2.8 mg/1LozengeOralDollar General75712-042
Mucinex Instasoothe Coughdextromethorphan hydrobromideDextromethorphan hydrobromide 5 mg/1LozengeOralReckitt Benckiser LLC72854-267
Rayo Breath Chamomilementhol, camphorMenthol 1 g/g; Camphor (Synthetic) 1 g/gCreamTopicalQuimicas Handal de Centroamerica SA de CV83033-1620
MGC Healthcough drops cherryMenthol 5.8 mg/1LozengeOralMedical Group Care LLC83173-100

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