Home NDC 51013-175 Night Time Severe Cold and Flu Relief
Product NDC 51013-175
11-digit product format 510130175
Labeler code 51013
Product ID 51013-175_27687339-8a9d-1973-e063-6394a90a44b2
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler PuraCap Pharmaceutical LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-06-09
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 Night Time Severe 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 1297288
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51013-175-04 Night Time Severe Cold and Flu Relief 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 3 51013-175-04 Night Time Severe Cold and Flu Relief 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51013-175 NIGHT TIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241122_3375a059-2939-438e-92b5-a7f1952bbb22.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 51013-175-04 51013017504 2 BLISTER PACK in 1 CARTON (51013-175-04) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2016-06-09 0000-00-00 No No Current