ultra concentrated daytime cold and flu

Generic: acetaminophen, dextromethorphan hydrobromide

Labeler: puracap pharmaceutical llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name ultra concentrated daytime cold and flu
Generic Name acetaminophen, dextromethorphan hydrobromide
Labeler puracap pharmaceutical llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

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

Manufacturer
PuraCap Pharmaceutical LLC

Identifiers & Regulatory

Product NDC 51013-667
Product ID 51013-667_300b2b2b-3aa6-fbf0-e063-6294a90a319b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-03-12

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 51013667
Hyphenated Format 51013-667

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 ultra concentrated daytime cold and flu (source: ndc)
Generic Name acetaminophen, 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 BLISTER PACK in 1 CARTON (51013-667-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

51013-667-01 1 BLISTER PACK in 1 CARTON (51013-667-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Ultra Concentrated Daytime COLD AND FLU ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "300b2b2b-3aa6-fbf0-e063-6294a90a319b", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH"], "rxcui": ["1867684"], "spl_set_id": ["300b2357-933b-fe9a-e063-6294a90aa4b9"], "manufacturer_name": ["PuraCap Pharmaceutical LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (51013-667-01)  / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "51013-667-01", "marketing_start_date": "20250312"}], "brand_name": "Ultra Concentrated Daytime COLD AND FLU", "product_id": "51013-667_300b2b2b-3aa6-fbf0-e063-6294a90a319b", "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": "51013-667", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE", "labeler_name": "PuraCap Pharmaceutical LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ultra Concentrated 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": "20250312", "listing_expiration_date": "20261231"}