cold and flu relief

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl

Labeler: chain drug consortium, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cold and flu relief
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl
Labeler chain drug consortium, llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

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

Manufacturer
Chain Drug Consortium, LLC

Identifiers & Regulatory

Product NDC 68016-797
Product ID 68016-797_d546bd5d-e7cc-41a6-a214-0b377f9a3335
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2022-09-02
Marketing End 2026-09-30

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 68016797
Hyphenated Format 68016-797

Supplemental Identifiers

RxCUI
1086997
UPC
0840986037658
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 and flu 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
  • 16 BLISTER PACK in 1 CARTON (68016-797-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

68016-797-16 16 BLISTER PACK in 1 CARTON (68016-797-16) / 1 CAPSULE, LIQUID FILLED 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 and Flu Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d546bd5d-e7cc-41a6-a214-0b377f9a3335", "openfda": {"upc": ["0840986037658"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086997"], "spl_set_id": ["99288aa3-e066-4a90-8887-6b4e302906fd"], "manufacturer_name": ["Chain Drug Consortium, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "16 BLISTER PACK in 1 CARTON (68016-797-16)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "68016-797-16", "marketing_end_date": "20260930", "marketing_start_date": "20220902"}], "brand_name": "Cold and Flu Relief", "product_id": "68016-797_d546bd5d-e7cc-41a6-a214-0b377f9a3335", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "68016-797", "generic_name": "Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl", "labeler_name": "Chain Drug Consortium, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold and Flu 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": "20260930", "marketing_start_date": "20220902"}