What is NDC 0363-9016?

0363-9016 is the product NDC for COLD, Flu and Sore Throat, Acetaminophen 325 mg/1 + 3 more ingredients capsule, liquid filled, listed with the FDA by Walgreens. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

COLD, Flu and Sore Throat (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE).

What is the active ingredient?

Acetaminophen, Guaifenesin, Dextromethorphan hydrobromide, Phenylephrine hydrochloride.

Walgreens, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for COLD, Flu and Sore Throat?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

COLD, Flu and Sore Throat NDC 0363-9016

NDC codes

FDA NDC Directory

Product NDC (as listed)0363-9016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00363-9016Add 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
0363-9016-16	00363901616	2 BLISTER PACK in 1 CARTON (0363-9016-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Aug 24, 2021

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): COLD, Flu and Sore Throat
Generic name (nonproprietary): acetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride
Active ingredients: Acetaminophen — 325 mg/1Guaifenesin — 200 mg/1Dextromethorphan hydrobromide — 10 mg/1Phenylephrine hydrochloride — 5 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: WalgreensNDC labeler code 0363
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Aug 24, 2021
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 0363-9016_4886f07a-f5fd-f25b-e063-6394a90a1b31SPL ID 4886f07a-f5fd-f25b-e063-6394a90a1b31SPL set ID 190175bb-c08a-4050-aacf-29a130cbe05cRxCUI 1656815UNII 362O9ITL9D, 495W7451VQ, 9D2RTI9KYH, 04JA59TNSJ
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

N400363901616 followed by a unit qualifier and the quantity

Package 00363-9016-16. 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 Jan 16, 2026.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0363-9016

What is NDC 0363-9016?: 0363-9016 is the product NDC for COLD, Flu and Sore Throat, Acetaminophen 325 mg/1 + 3 more ingredients capsule, liquid filled, listed with the FDA by Walgreens. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: COLD, Flu and Sore Throat (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE).
What is the active ingredient?: Acetaminophen, Guaifenesin, Dextromethorphan hydrobromide, Phenylephrine hydrochloride.
Who is the labeler?: Walgreens, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for COLD, Flu and Sore Throat?: 5 other product NDCs are listed under this name. See all COLD, Flu and Sore Throat 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 COLD, Flu and Sore Throat NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cold, Flu and Sore Throatacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, Film coatedOral	Meijer Distribution, Inc.	79481-6171	79481-6171-09
Cold, Flu and Sore Throatacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl	Acetaminophen 650 mg/20mL + 3 more ingredients	SolutionOral	Family Dollar Services Inc	55319-705	55319-0705-45
Cold, Flu and Sore Throatacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl	Acetaminophen 650 mg/20mL + 3 more ingredients	SolutionOral	Walgreen Company	0363-8005	00363-8005-45
Cold Flu And Sore Throatacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, CoatedOral	RETAIL BUSINESS SERVICES , LLC.	72476-197	72476-0197-04
Cold Flu and Sore Throatacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, CoatedOral	PUBLIX SUPER MARKETS INC	56062-197	56062-0197-04

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
Cold and Flu HBPacetaminophen, chlorpheniramine maleate	Acetaminophen 325 mg/1; Chlorpheniramine maleate 2 mg/1	Tablet, Film coatedOral	WALMART INC.	79903-120
Equate Daytime Nighttime Vapor Ice Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	—	Kit	WALMART INC.	79903-417
Night Time Cold and Flu ReadyInCaseacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	LiquidOral	P & L Development, LLC	49580-0343
Sinus Severeacetaminophen, guaifenesin, phenylephrine hcl	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, Film coatedOral	L.N.K. International, Inc.	50844-572
SUDAFED PE Head Congestion Plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, Film coatedOral	Kenvue Brands LLC	50580-450
Nighttime severe cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl	Dextromethorphan hydrobromide 20 mg/30mL + 3 more ingredients	LiquidOral	TARGET CORPORATION	11673-828
Freegells Cough Drops Menthol Cherry 30ctmenthol	Levomenthol 5.8 mg/1	LozengeOral	RL Albert & Son Inc.	83002-040
Sanatosmenthol	Menthol 5.4 mg/1	LozengeOral	Pharmadel LLC	55758-518
Pressure and Pain Plus Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, CoatedOral	VALU MERCHANDISERS COMPANY	63941-173
Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl	Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients	SyrupOral	Dextrum Laboratories, Inc	65852-020
Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hbr and doxylamine succinate	Acetaminophen 325 mg/1 + 2 more ingredients	CapsuleOral	Chain Drug Consortium, LLC	68016-878
Head Congestion plus Flu Severe PEacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, CoatedOral	HARRIS TEETER	72036-274
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttimeacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl	Acetaminophen 1000 mg/30mL + 3 more ingredients	SyrupOral	Haleon US Holdings LLC	0067-0114
Childrens Cough and Congestion, Childrens Cold and Cough Day, Nightdextromethorphan hbr, doxylamine succinate, guaifenesin	—	Kit	WALMART INC.	79903-414
Meijer Adult MS Severe Multi-Symptom Cough Cold Fluaacetaminophen, dextromethorphan hbr and guaifenesi	Acetaminophen 650 mg/20mL + 2 more ingredients	LiquidOral	MEIJER DISTRIBUTION INC	79481-6308
Menthol Cough Dropsmenthol	Menthol 5.8 mg/1	PastilleOral	Target Corporation Inc.	82442-001
adult dm max cough and chest congestiondextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL	SolutionOral	Meijer Distribution Inc	41250-261
Bio-Rytusschlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride	Chlorpheniramine maleate 2 mg/5mL + 2 more ingredients	LiquidOral	Advanced Generic Corporation	45737-250
Allergy Reliefdiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/1	TabletOral	AMERISOURCE BERGEN	46122-829
Cold Relief Multi-Symptomacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl	—	Kit	L.N.K. International, Inc.	50844-529

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