nuvicare daytime cold and flu softgel

Generic: acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

Labeler: nuvicare llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nuvicare daytime cold and flu softgel
Generic Name acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
Labeler nuvicare 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
NUVICARE LLC

Identifiers & Regulatory

Product NDC 84324-023
Product ID 84324-023_6b80519a-1e97-464a-b7ce-baa26ede64db
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-06-09

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 84324023
Hyphenated Format 84324-023

Supplemental Identifiers

RxCUI
1086997
UPC
0384324000190
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 nuvicare daytime cold and flu softgel (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride (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
  • 1 BLISTER PACK in 1 CARTON (84324-023-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

84324-023-01 1 BLISTER PACK in 1 CARTON (84324-023-01) / 10 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)

Nuvicare DayTime Cold and Flu Softgel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6b80519a-1e97-464a-b7ce-baa26ede64db", "openfda": {"upc": ["0384324000190"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086997"], "spl_set_id": ["bdc35570-c8df-4797-a13e-7f2479ec42b7"], "manufacturer_name": ["NUVICARE LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (84324-023-01)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "84324-023-01", "marketing_start_date": "20250609"}], "brand_name": "Nuvicare DayTime Cold and Flu Softgel", "product_id": "84324-023_6b80519a-1e97-464a-b7ce-baa26ede64db", "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": "84324-023", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "NUVICARE LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nuvicare DayTime Cold and Flu Softgel", "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_start_date": "20250609", "listing_expiration_date": "20261231"}