leader daytime severe cold and flu relief

Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name leader daytime severe cold and flu relief
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Labeler cardinal health 110, llc. dba leader
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0636
Product ID 70000-0636_5d04a7de-57f2-47ea-a33e-e901ffa17883
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-06-15

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 700000636
Hyphenated Format 70000-0636

Supplemental Identifiers

RxCUI
1110988
UPC
0096295142747
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 leader 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
  • 12 BLISTER PACK in 1 CARTON (70000-0636-1) / 2 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

70000-0636-1 12 BLISTER PACK in 1 CARTON (70000-0636-1) / 2 TABLET, FILM COATED 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)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5d04a7de-57f2-47ea-a33e-e901ffa17883", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0096295142747"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1110988"], "spl_set_id": ["dd82a389-9ec5-4b3f-a9ea-1a56871ebd17"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (70000-0636-1)  / 2 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "70000-0636-1", "marketing_start_date": "20230615"}], "brand_name": "Leader Daytime Severe Cold and Flu Relief", "product_id": "70000-0636_5d04a7de-57f2-47ea-a33e-e901ffa17883", "dosage_form": "TABLET, FILM COATED", "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": "70000-0636", "generic_name": "acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader 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": "20230615", "listing_expiration_date": "20261231"}