ultra concentrated nighttime cold and flu

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate

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

Drug Facts

Product Profile

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

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, doxylamine succinate 6.25 mg/1

Manufacturer
PuraCap Pharmaceutical LLC

Identifiers & Regulatory

Product NDC 51013-668
Product ID 51013-668_300bf27f-7450-7366-e063-6394a90acbcb
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
antihistamine [epc] histamine receptor antagonists [moa] 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 51013668
Hyphenated Format 51013-668

Supplemental Identifiers

RxCUI
1426334
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2

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

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (51013-668-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

51013-668-01 1 BLISTER PACK in 1 CARTON (51013-668-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) doxylamine succinate (6.25 mg/1)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "300bf27f-7450-7366-e063-6394a90acbcb", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1426334"], "spl_set_id": ["300bf27f-744f-7366-e063-6394a90acbcb"], "manufacturer_name": ["PuraCap Pharmaceutical LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (51013-668-01)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "51013-668-01", "marketing_start_date": "20250312"}], "brand_name": "Ultra Concentrated Nighttime COLD AND FLU", "product_id": "51013-668_300bf27f-7450-7366-e063-6394a90acbcb", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "51013-668", "generic_name": "acetaminophen, dextromethorphan hydrobromide, doxylamine succinate", "labeler_name": "PuraCap Pharmaceutical LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ultra Concentrated Nighttime COLD AND FLU", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250312", "listing_expiration_date": "20261231"}