Home NDC 11822-0677 Severe Nighttime Cold and Flu Relief
Product NDC 11822-0677
11-digit product format 118220677
Labeler code 11822
Product ID 11822-0677_d2b296f2-4b0f-42c9-b43e-6a3e39bba525
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rite Aid Corporation
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-12-10
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 Severe Nighttime Cold and Flu Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ Rxcui 1546881
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11822-0677-8 Severe Nighttime Cold and Flu Relief 2 in 1 CARTON TABLET, FILM COATED 2 8 11822-0677-8 Severe Nighttime Cold and Flu Relief 12 in 1 BLISTER PACK TABLET, FILM COATED 12 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11822-0677 SEVERE NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 7 Current NDC, Legacy NDC, 2 package rows 20240824_627beff0-6716-41b3-a69d-8e7a7793cf63.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 11822-0677-8 11822067708 2 BLISTER PACK in 1 CARTON (11822-0677-8) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2019-12-10 0000-00-00 No No Current