What is NDC 0280-8294?

0280-8294 is the product NDC for Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels, Guaifenesin 200 mg/1 + 3 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 COLD Cold Mucus Congestion Maximum Strength Fast Gels (Acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride).

What is the active ingredient?

Guaifenesin, Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride.

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 COLD Cold Mucus Congestion Maximum Strength Fast Gels?

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.

NDC 0280-8294

NDC codes

FDA NDC Directory

Product NDC (as listed)0280-8294Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00280-8294Add 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 NDC	11-digit (billing)	Package	Copy
0280-8294-24	00280829424	3 BLISTER PACK in 1 CARTON (0280-8294-24) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jun 1, 2026

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

Brand name (proprietary): Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels
Generic name (nonproprietary): acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Active ingredients: Guaifenesin — 200 mg/1Acetaminophen — 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: Jun 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 0280-8294_51a45db8-2bef-6fd0-e063-6394a90ab587SPL ID 51a45db8-2bef-6fd0-e063-6394a90ab587SPL set ID 51a45db8-2bee-6fd0-e063-6394a90ab587RxCUI 1656815UNII 495W7451VQ, 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJUPC 0016500584209
Pharmacologic class: Expectorant; 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

N400280829424 followed by a unit qualifier and the quantity

Package 00280-8294-24. 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 May 12, 2026.

Indications (excerpt from the label)

Uses Uses · helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive · temporarily relieves these symptoms due to a cold or flu: · nasal congestion · sinus congestion and pressure · minor aches and pains · headache · cough · sore throat · temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0280-8294

What is NDC 0280-8294?: 0280-8294 is the product NDC for Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels, Guaifenesin 200 mg/1 + 3 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 COLD Cold Mucus Congestion Maximum Strength Fast Gels (Acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride).
What is the active ingredient?: Guaifenesin, 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 COLD Cold Mucus Congestion Maximum Strength Fast Gels?: 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
Product	Strength	Form · route	Labeler	Product NDC
Theraflu Flu Relief Max Strength Daytime Nighttime Combo Packacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr	—	Kit	Haleon US Holdings LLC	0067-7923
QUALITY CHOICE DayTime Severe Cold and Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Capsule, Liquid filledOral	Chain Drug Marketing Association, Inc.	83324-037
SudoGestpseudoephedrine hcl	Pseudoephedrine hydrochloride 30 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-5053
Cold and Flu Relief Daytimeacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	Capsule, Liquid filledOral	H E B	37808-848
Maximum Strength Mucus Reliefdextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL	LiquidOral	Hyvee Inc	42507-630
CVS PHARMACY Childrens Allergy Chewsdiphenhydramine hcl	Diphenhydramine hydrochloride 12.5 mg/1	Tablet, ChewableOral	CVS PHARMACY, INC.	51316-154
Natural Honey Lemon with Echinacea Cough Suppressant Throat Dropsmenthol	Menthol 3.5 mg/1	LozengeOral	Ricola Ag	54305-467
Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	SolutionOral	ARMY AND AIR FORCE EXCHANGE SERVICE	55301-310
Giltuss Childrens MultiSymptom Cold and Fluacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride	Chlorpheniramine maleate 2 mg/5mL + 3 more ingredients	SolutionOral	Giltuss Pharmaceutical Corp	58552-137
Cough Dropsmenthol	Menthol 7.5 mg/1	PastilleOral	Topco Associates LLC	76162-027
Mucinex Nightshift Severe Cold and Fluacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride	Acetaminophen 650 mg/20mL + 3 more ingredients	SolutionOral	Reckitt Benckiser LLC	63824-504
Childrens Mucus and Cough Reliefguaifenesin and dextromethorphan hydrobromide	Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL	LiquidOral	Chain Drug Manufacturing Assn	63868-771
Childrens Cold and Allergybrompheniramine maleate, phenylephrine hcl	Brompheniramine maleate 2 mg/10mL; Phenylephrine hydrochloride 5 mg/10mL	LiquidOral	CVS Pharmacy	69842-779
Cough and Cold Therapy For Kidscamphor, menthol, eucalyptus oil	Camphor (Natural) 4.7 g/100g + 2 more ingredients	OintmentTopical	Everlaan Organics Inc	83670-201
QUALITY CHOICE Cough Drops Vanilla Honeymenthol	Menthol, Unspecified form 2.5 mg/1	LozengeOral	Chain Drug Marketing Association, Inc.	83324-308
Refenesen Mucus Relief DMdextromethorphan hydrobromide / guaifenesin	Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1	TabletOral	Reese Pharmaceutical Co	10956-846
Daytime Severe Cold And Flu Maximum Strengthacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, CoatedOral	HEB	37808-178
Throat Comfort Lemon Mint Ginger Dropsmenthol	Menthol 3.4 mg/1	LozengeOral	Ricola Ag	54305-341
dg health night time cold and flu reliefacetaminophen, dextromethorphan hbr, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	SolutionOral	Dolgencorp Inc	55910-335
Allergy Reliefdiphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Strategic Sourcing Services LLC	70677-1014

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Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels NDC 0280-8294