Home NDC 36800-474 Head Congestion plus Flu Severe PE
Product NDC 36800-474
11-digit product format 368000474
Labeler code 36800
Product ID 36800-474_28602044-66bd-59f6-e063-6294a90aa8d9
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler TOPCO ASSOCIATES LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-30
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-474-02 Head Congestion plus Flu Severe PE 12 in 1 BLISTER PACK TABLET, COATED 12 5 36800-474-02 Head Congestion plus Flu Severe PE 2 in 1 CARTON TABLET, COATED 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-474 HEAD CONGESTION PLUS FLU SEVERE PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCO ASSOCIATES LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241206_bd09e4f3-3211-8c08-e053-2a95a90a73f9.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 36800-474-02 36800047402 2 BLISTER PACK in 1 CARTON (36800-474-02) / 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2021-04-30 0000-00-00 No No Current