Head Congestion plus Flu Severe

Product NDC
37808-574
11-digit product format
378080574
Labeler code
37808
Product ID
37808-574_25007d2b-6980-8031-e063-6394a90a5efe
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
HEB
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-14
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic 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
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
9D2RTI9KYHDEXTROMETHORPHAN HYDROBROMIDE6700-34-1DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQGUAIFENESIN93-14-1GUAIFENESIN
04JA59TNSJPHENYLEPHRINE HYDROCHLORIDE61-76-7PHENYLEPHRINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37808-574-02378080574022 BLISTER PACK in 1 CARTON (37808-574-02) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2023-04-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
1174-HEB-2023-0414HEB2024-10-21HUMAN OTC DRUG LABEL3