nitetime severe cold and flu relief softgels

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nitetime severe cold and flu relief softgels
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
Labeler topco associates 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, phenylephrine hydrochloride 5 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-637
Product ID 76162-637_9d7397f8-c4b7-413a-b700-dfc119c05328
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-12-11

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] 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] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162637
Hyphenated Format 76162-637

Supplemental Identifiers

RxCUI
1297288
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2 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 nitetime severe cold and flu relief softgels (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 6.25 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (76162-637-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

76162-637-24 2 BLISTER PACK in 1 CARTON (76162-637-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) doxylamine succinate (6.25 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

NiteTime SEVERE Cold and Flu Relief SOFTGELS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9d7397f8-c4b7-413a-b700-dfc119c05328", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["1297288"], "spl_set_id": ["3ffe67bf-2c66-61e6-e063-6394a90a7f8f"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (76162-637-24)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "76162-637-24", "marketing_start_date": "20251211"}], "brand_name": "NiteTime SEVERE Cold and Flu Relief SOFTGELS", "product_id": "76162-637_9d7397f8-c4b7-413a-b700-dfc119c05328", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "76162-637", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NiteTime SEVERE Cold and Flu Relief SOFTGELS", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251211", "listing_expiration_date": "20261231"}