cold relief

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl

Labeler: united natural foods, inc. dba unfi
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cold relief
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl
Labeler united natural foods, inc. dba unfi
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
United Natural Foods, Inc. dba UNFI

Identifiers & Regulatory

Product NDC 41163-907
Product ID 41163-907_1e4824a3-bf78-4b1e-b9f1-9e0beddd4caf
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2021-12-15
Marketing End 2027-04-30

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 41163907
Hyphenated Format 41163-907

Supplemental Identifiers

RxCUI
1094538
UPC
0041163503328
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 cold relief (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (41163-907-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

41163-907-08 2 BLISTER PACK in 1 CARTON (41163-907-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (3)

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

Linked Drug Pages (1)

Cold Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1e4824a3-bf78-4b1e-b9f1-9e0beddd4caf", "openfda": {"upc": ["0041163503328"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1094538"], "spl_set_id": ["b919f0fe-fae0-4bd8-9ccd-d7569b2a7070"], "manufacturer_name": ["United Natural Foods, Inc. dba UNFI"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (41163-907-08)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "41163-907-08", "marketing_end_date": "20270430", "marketing_start_date": "20211215"}], "brand_name": "Cold Relief", "product_id": "41163-907_1e4824a3-bf78-4b1e-b9f1-9e0beddd4caf", "dosage_form": "TABLET, FILM COATED", "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": "41163-907", "generic_name": "Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl", "labeler_name": "United Natural Foods, Inc. dba UNFI", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20270430", "marketing_start_date": "20211215"}