nighttime cold and flu

Generic: acetaminophen,dextromethorphan,doxylamine

Labeler: velocity pharma
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime cold and flu
Generic Name acetaminophen,dextromethorphan,doxylamine
Labeler velocity pharma
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 15 mg/1, doxylamine succinate 6.25 mg/1

Manufacturer
Velocity Pharma

Identifiers & Regulatory

Product NDC 76168-056
Product ID 76168-056_58ee90a2-07a9-2253-e053-2a91aa0ad9cf
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part341
Listing Expiration 2026-12-31
Marketing Start 2014-05-01

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 76168056
Hyphenated Format 76168-056

Supplemental Identifiers

RxCUI
1094549
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 nighttime cold and flu (source: ndc)
Generic Name acetaminophen,dextromethorphan,doxylamine (source: ndc)
Application Number part341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 15 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 12 CARTON in 1 BLISTER PACK (76168-056-02) / 1 CAPSULE, LIQUID FILLED in 1 CARTON
source: ndc

Packages (1)

76168-056-02 12 CARTON in 1 BLISTER PACK (76168-056-02) / 1 CAPSULE, LIQUID FILLED in 1 CARTON

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (15 mg/1) doxylamine succinate (6.25 mg/1)

Linked Drug Pages (1)

NightTime Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "58ee90a2-07a9-2253-e053-2a91aa0ad9cf", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1094549"], "spl_set_id": ["516fc924-61f0-40ee-9688-3c6da817b462"], "manufacturer_name": ["Velocity Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 CARTON in 1 BLISTER PACK (76168-056-02)  / 1 CAPSULE, LIQUID FILLED in 1 CARTON", "package_ndc": "76168-056-02", "marketing_start_date": "20170801"}], "brand_name": "NightTime Cold and Flu", "product_id": "76168-056_58ee90a2-07a9-2253-e053-2a91aa0ad9cf", "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": "76168-056", "generic_name": "Acetaminophen,Dextromethorphan,Doxylamine", "labeler_name": "Velocity Pharma", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NightTime Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}], "application_number": "part341", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "20140501", "listing_expiration_date": "20261231"}