Home NDC 49580-0502 Nighttime Severe Cold and Cough
Product NDC 49580-0502
11-digit product format 495800502
Labeler code 49580
Product ID 49580-0502_48c92b40-7cf7-492b-96d4-d4209532fcdc
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler P & L Development, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-30
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650; 25; 10 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nighttime Severe Cold and Cough
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/30mL DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/30mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1298348 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49580-0502-8 Nighttime Severe Cold and Cough 245 mL in 1 BOTTLE, PLASTIC LIQUID 245 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0502 NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [P & L DEVELOPMENT, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20240417_8d27b94d-23a1-4e6c-a064-79e2580f7e2e.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
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 49580-0502-8 49580050208 245 mL in 1 BOTTLE, PLASTIC (49580-0502-8) 245 ml 2021-04-30 0000-00-00 No No Current