NDC 0363-0603

Severe Cold and Flu

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Severe Cold and Flu is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Walgreen Company. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 0363-0603_5775e31a-1333-4f37-9a95-0b1f4c4281a2
• NDC: 0363-0603
• Product Type: Human Otc Drug
• Proprietary Name: Severe Cold and Flu
• Generic Name: Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2013-11-21
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Walgreen Company
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
• Pharm Classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0363-0603-34

237 mL in 1 BOTTLE (0363-0603-34)

• Marketing Start Date: 2019-04-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0363-0603-34 [00363060334]

Severe Cold and Flu SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-04-04

NDC 0363-0603-40 [00363060340]

Severe Cold and Flu SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-11-21

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/15mL

OpenFDA Data

• SPL SET ID: 54254b61-7861-4eeb-bd3c-54fd5266f4a7
• Manufacturer:
  • Walgreen Company
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1369842

NDC Crossover Matching brand name "Severe Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
0363-0603	Severe Cold and Flu	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0363-0623	severe cold and flu	Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
68998-163	Severe Cold and Flu	Severe Cold and Flu
15127-184	Severe Cold and Flu	Severe Cold and Flu
37808-619	severe cold and flu	severe cold and flu
42507-603	Severe Cold and Flu	Severe Cold and Flu
49035-945	Severe Cold and Flu	Severe Cold and Flu
56062-319	severe cold and flu	severe cold and flu
0363-0763	Severe Cold and Flu	Severe Cold and Flu
0363-1597	Severe Cold and Flu	Severe Cold and Flu
62011-0241	Severe Cold and Flu	Severe Cold and Flu
63868-003	Severe Cold and Flu	Severe Cold and Flu
0363-1940	severe cold and flu	severe cold and flu
69842-972	Severe Cold and Flu	Severe Cold and Flu
63940-342	Severe Cold and Flu	Severe Cold and Flu
70000-0525	Severe Cold and Flu	Severe Cold and Flu
0113-7603	Basic Care Daytime Cold and Flu Severe	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0113-7303	basic care mucus relief cold flu and sore throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0640	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0299	good sense cold and flu severe	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0234	good sense cold head congestion	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0381	Good Sense Mucus Relief	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-1913	good sense mucus relief cold flu and sore throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0579	good sense severe cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0548	Good Sense Severe Daytime	acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
0113-0603	Good Sense Severe Daytime Cold and Flu	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0113-9007	Good Sense Severe Tussin CF Max	Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
0363-0616	Mucus Relief	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0538	Mucus Relief Cold Flu Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0372	Mucus Relief Plus	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0410	Mucus Relief Severe Cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0503	Severe Cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0524	Sinus Relief	Acetaminophen, Dextromethorphan HBR, Guaifenesin, Phenylephrine HCl
0067-8145	Theraflu ExpressMax Severe Cold and Flu Caplets	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0067-8132	Theraflu ExpressMax Severe Cold and Flu Syrup	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0051	Wal Tussin CF Max	Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl