NDC codes

FDA NDC Directory
Product NDC (as listed)0280-1580Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00280-1580Add 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
0280-1580-2000280158020002801580201 KIT in 1 CARTON (0280-1580-20) * 2 BLISTER PACK in 1 CARTON / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from May 22, 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, doxylamine succinate, phenylephrine hydrochloride
Dosage form
Kit
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
Identifiers
Product ID 0280-1580_45267a4c-d228-b1b5-e063-6394a90a81bfSPL ID 45267a4c-d228-b1b5-e063-6394a90a81bfSPL set ID 51c44970-06e5-082e-e054-00144ff88e88RxCUI 1086997, 1297288, 2634363UPC 0016500555315

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

N400280158020 followed by a unit qualifier and the quantity

Package 00280-1580-20. 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 0280-1580

What is NDC 0280-1580?
0280-1580 is the product NDC for Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu kit, 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 and Night Cold and Flu (Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, 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 and Night Cold and Flu?
5 other product NDCs are listed under this name. See all Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu 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 Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Fludextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride, doxylamine succinate—KitOralBayer HealthCare LLC.0280-004000280-0040-01
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gelsacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate—KitBayer HealthCare LLC.0280-012500280-0125-01
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gelsacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate—KitBayer HealthCare LLC.0280-165000280-1650-16
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gelsacetaminophen, dextrmethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride—KitBayer HealthCare LLC.0280-168000280-1680-24
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride—KitOralBayer HealthCare LLC.0280-158100280-1581-40

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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