daytime cold and flu

Generic: acetaminophen and dextromethorphan hydrobromide

Labeler: humanwell puracap pharmaceuticals (wuhan) co., ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name daytime cold and flu
Generic Name acetaminophen and dextromethorphan hydrobromide
Labeler humanwell puracap pharmaceuticals (wuhan) co., ltd
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1

Manufacturer
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd

Identifiers & Regulatory

Product NDC 53345-056
Product ID 53345-056_46995a36-4233-ddce-e063-6294a90a1b8e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-12-28

Pharmacologic Class

Classes
sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53345056
Hyphenated Format 53345-056

Supplemental Identifiers

RxCUI
1867684
UNII
362O9ITL9D 9D2RTI9KYH

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 cold and flu (source: ndc)
Generic Name acetaminophen and dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 1 BAG in 1 CARTON (53345-056-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (1)

53345-056-01 1 BAG in 1 CARTON (53345-056-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (2)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1)

Linked Drug Pages (1)

Daytime Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46995a36-4233-ddce-e063-6294a90a1b8e", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH"], "rxcui": ["1867684"], "spl_set_id": ["46996bbf-948c-0aba-e063-6394a90a09e3"], "manufacturer_name": ["Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 CARTON (53345-056-01)  / 4000 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "53345-056-01", "marketing_start_date": "20251228"}], "brand_name": "Daytime Cold and Flu", "product_id": "53345-056_46995a36-4233-ddce-e063-6294a90a1b8e", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "53345-056", "generic_name": "Acetaminophen and Dextromethorphan hydrobromide", "labeler_name": "Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Daytime Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251228", "listing_expiration_date": "20261231"}