severe cold and flu relief daytime

Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name severe cold and flu relief daytime
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Labeler p & l development, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/15mL, dextromethorphan hydrobromide 10 mg/15mL, guaifenesin 200 mg/15mL, phenylephrine hydrochloride 5 mg/15mL

Manufacturer
P & L Development, LLC

Identifiers & Regulatory

Product NDC 49580-0415
Product ID 49580-0415_c005f7ca-3f3b-4dbb-80fe-8cde626f13d5
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

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 495800415
Hyphenated Format 49580-0415

Supplemental Identifiers

RxCUI
1369842
UPC
0349580415089
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

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 flu relief daytime (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/15mL
  • 10 mg/15mL
  • 200 mg/15mL
  • 5 mg/15mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE, PLASTIC (49580-0415-8)
source: ndc

Packages (1)

49580-0415-8 237 mL in 1 BOTTLE, PLASTIC (49580-0415-8)

Ingredients (4)

acetaminophen (325 mg/15mL) dextromethorphan hydrobromide (10 mg/15mL) guaifenesin (200 mg/15mL) phenylephrine hydrochloride (5 mg/15mL)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c005f7ca-3f3b-4dbb-80fe-8cde626f13d5", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0349580415089"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1369842"], "spl_set_id": ["5872fed8-862b-44a2-a06e-51ebf8618271"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["P & L Development, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE, PLASTIC (49580-0415-8)", "package_ndc": "49580-0415-8", "marketing_start_date": "20210326"}], "brand_name": "Severe Cold and Flu Relief Daytime", "product_id": "49580-0415_c005f7ca-3f3b-4dbb-80fe-8cde626f13d5", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "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": "49580-0415", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe Cold and Flu Relief", "brand_name_suffix": "Daytime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/15mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/15mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210326", "listing_expiration_date": "20261231"}