daytime severe cold and flu relief

Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Labeler: puracap pharmaceutical llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name daytime severe cold and flu relief
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Labeler puracap pharmaceutical llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
PuraCap Pharmaceutical LLC

Identifiers & Regulatory

Product NDC 51013-174
Product ID 51013-174_27684255-ae75-da99-e063-6394a90af8e6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2016-06-13

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 51013174
Hyphenated Format 51013-174

Supplemental Identifiers

RxCUI
1656815
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 daytime severe cold and flu relief (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/1
  • 10 mg/1
  • 200 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (51013-174-04) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

51013-174-04 2 BLISTER PACK in 1 CARTON (51013-174-04) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "27684255-ae75-da99-e063-6394a90af8e6", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1656815"], "spl_set_id": ["856cb3c3-8f32-4285-8c13-25f01779a31a"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["PuraCap Pharmaceutical LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (51013-174-04)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "51013-174-04", "marketing_start_date": "20160613"}], "brand_name": "Daytime Severe Cold and Flu Relief", "product_id": "51013-174_27684255-ae75-da99-e063-6394a90af8e6", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "51013-174", "generic_name": "acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride", "labeler_name": "PuraCap Pharmaceutical LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Daytime Severe Cold and Flu Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160613", "listing_expiration_date": "20261231"}