asp daytime pe

Generic: acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name asp daytime pe
Generic Name acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
Labeler humanwell puracap pharmaceutical (wuhan), ltd.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

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

Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

Identifiers & Regulatory

Product NDC 53345-052
Product ID 53345-052_27c81691-e7ca-70c6-e063-6394a90a4888
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-08-01

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 53345052
Hyphenated Format 53345-052

Supplemental Identifiers

RxCUI
1086997
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 asp daytime pe (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 BAG in 1 BOX (53345-052-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (1)

53345-052-01 1 BAG in 1 BOX (53345-052-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (3)

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

Linked Drug Pages (1)

ASP Daytime PE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "27c81691-e7ca-70c6-e063-6394a90a4888", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086997"], "spl_set_id": ["b84f2392-0b24-4af0-80f7-c45454093f51"], "manufacturer_name": ["Humanwell PuraCap Pharmaceutical (Wuhan), Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 BOX (53345-052-01)  / 4000 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "53345-052-01", "marketing_start_date": "20200801"}], "brand_name": "ASP Daytime PE", "product_id": "53345-052_27c81691-e7ca-70c6-e063-6394a90a4888", "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": "53345-052", "generic_name": "acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride", "labeler_name": "Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ASP Daytime PE", "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": "20200801", "listing_expiration_date": "20261231"}