severe cold and cough relief daytime

Generic: acetaminohpen, dextromethorphan hbr, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name severe cold and cough relief daytime
Generic Name acetaminohpen, dextromethorphan hbr, phenylephrine hcl
Labeler p & l development, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 20 mg/30mL, phenylephrine hydrochloride 10 mg/30mL

Manufacturer
P & L Development, LLC

Identifiers & Regulatory

Product NDC 49580-0501
Product ID 49580-0501_a105492f-6843-463d-8a44-01d89916d833
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-03-26

Pharmacologic Class

Classes
adrenergic alpha1-agonists [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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 495800501
Hyphenated Format 49580-0501

Supplemental Identifiers

RxCUI
1113705
UPC
0349580501836
UNII
362O9ITL9D 9D2RTI9KYH 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 severe cold and cough relief daytime (source: ndc)
Generic Name acetaminohpen, dextromethorphan hbr, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 20 mg/30mL
  • 10 mg/30mL
source: ndc
Packaging
  • 245 mL in 1 BOTTLE, PLASTIC (49580-0501-8)
source: ndc

Packages (1)

49580-0501-8 245 mL in 1 BOTTLE, PLASTIC (49580-0501-8)

Ingredients (3)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (20 mg/30mL) phenylephrine hydrochloride (10 mg/30mL)

Linked Drug Pages (1)

Severe Cold and Cough Relief Daytime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a105492f-6843-463d-8a44-01d89916d833", "openfda": {"upc": ["0349580501836"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1113705"], "spl_set_id": ["2af496a1-6fdd-4acf-9944-8b7cdf302275"], "manufacturer_name": ["P & L Development, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "245 mL in 1 BOTTLE, PLASTIC (49580-0501-8)", "package_ndc": "49580-0501-8", "marketing_start_date": "20210326"}], "brand_name": "Severe Cold and Cough Relief Daytime", "product_id": "49580-0501_a105492f-6843-463d-8a44-01d89916d833", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [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]"], "product_ndc": "49580-0501", "generic_name": "ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe Cold and Cough Relief", "brand_name_suffix": "Daytime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/30mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210326", "listing_expiration_date": "20261231"}