Home NDC 72476-174 HEAD CONGESTION PLUS FLU SEVERE PE
Product NDC 72476-174
11-digit product format 724760174
Labeler code 72476
Product ID 72476-174_248a3c31-d35b-37aa-e063-6394a90a1072
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler RETAIL BUSINESS SERVICES , LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-10-25
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 Additional Listing Data#
Finished product Yes
Brand name base HEAD CONGESTION PLUS FLU SEVERE PE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 100 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ Rxcui 1098435
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72476-174-02 HEAD CONGESTION PLUS FLU SEVERE PE 12 in 1 BLISTER PACK TABLET, COATED 12 3 72476-174-02 HEAD CONGESTION PLUS FLU SEVERE PE 2 in 1 CARTON TABLET, COATED 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72476-174 HEAD CONGESTION PLUS FLU SEVERE PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RETAIL BUSINESS SERVICES , LLC.] 3 Current NDC, Legacy NDC, 2 package rows 20241017_e65cf21d-3d69-a53e-e053-2a95a90a1c83.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72476-174-02 72476017402 2 BLISTER PACK in 1 CARTON (72476-174-02) / 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2022-10-25 0000-00-00 No No Current