nighttime severe cold and cough

Generic: acetaminophen, diphenhydramine hcl, phenylephrine hcl

Labeler: p & l development, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime severe cold and cough
Generic Name acetaminophen, diphenhydramine hcl, phenylephrine hcl
Labeler p & l development, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, diphenhydramine hydrochloride 25 mg/30mL, phenylephrine hydrochloride 10 mg/30mL

Manufacturer
P & L Development, LLC

Identifiers & Regulatory

Product NDC 49580-0502
Product ID 49580-0502_48c92b40-7cf7-492b-96d4-d4209532fcdc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-04-30

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 495800502
Hyphenated Format 49580-0502

Supplemental Identifiers

RxCUI
1298348
UNII
362O9ITL9D TC2D6JAD40 04JA59TNSJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nighttime severe cold and cough (source: ndc)
Generic Name acetaminophen, diphenhydramine hcl, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 25 mg/30mL
  • 10 mg/30mL
source: ndc
Packaging
  • 245 mL in 1 BOTTLE, PLASTIC (49580-0502-8)
source: ndc

Packages (1)

49580-0502-8 245 mL in 1 BOTTLE, PLASTIC (49580-0502-8)

Ingredients (3)

acetaminophen (650 mg/30mL) diphenhydramine hydrochloride (25 mg/30mL) phenylephrine hydrochloride (10 mg/30mL)

Linked Drug Pages (1)

Nighttime Severe Cold and Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48c92b40-7cf7-492b-96d4-d4209532fcdc", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1298348"], "spl_set_id": ["8d27b94d-23a1-4e6c-a064-79e2580f7e2e"], "manufacturer_name": ["P & L Development, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "245 mL in 1 BOTTLE, PLASTIC (49580-0502-8)", "package_ndc": "49580-0502-8", "marketing_start_date": "20210430"}], "brand_name": "Nighttime Severe Cold and Cough", "product_id": "49580-0502_48c92b40-7cf7-492b-96d4-d4209532fcdc", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "49580-0502", "generic_name": "Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Severe Cold and Cough", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/30mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210430", "listing_expiration_date": "20261231"}