nighttime cold and flu maximum strength

Generic: acetaminophen, diphenhydramine hci, phenylephrine hci

Labeler: dolgencorp, inc. (dollar general & rexall)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime cold and flu maximum strength
Generic Name acetaminophen, diphenhydramine hci, phenylephrine hci
Labeler dolgencorp, inc. (dollar general & rexall)
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/20mL, diphenhydramine hydrochloride 25 mg/20mL, phenylephrine hydrochloride 10 mg/20mL

Manufacturer
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Identifiers & Regulatory

Product NDC 55910-460
Product ID 55910-460_eee9692c-a80b-42f7-b4f9-6dc805077099
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2018-03-31
Marketing End 2027-03-31

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55910460
Hyphenated Format 55910-460

Supplemental Identifiers

RxCUI
1375932
UNII
362O9ITL9D TC2D6JAD40 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 nighttime cold and flu maximum strength (source: ndc)
Generic Name acetaminophen, diphenhydramine hci, phenylephrine hci (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/20mL
  • 25 mg/20mL
  • 10 mg/20mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (55910-460-06)
source: ndc

Packages (1)

55910-460-06 177 mL in 1 BOTTLE, PLASTIC (55910-460-06)

Ingredients (3)

acetaminophen (650 mg/20mL) diphenhydramine hydrochloride (25 mg/20mL) phenylephrine hydrochloride (10 mg/20mL)

Linked Drug Pages (1)

Nighttime Cold and Flu Maximum Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eee9692c-a80b-42f7-b4f9-6dc805077099", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1375932"], "spl_set_id": ["776b7c67-56c7-420c-82b2-9a176d998396"], "manufacturer_name": ["Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (55910-460-06)", "package_ndc": "55910-460-06", "marketing_end_date": "20270331", "marketing_start_date": "20180331"}], "brand_name": "Nighttime Cold and Flu Maximum Strength", "product_id": "55910-460_eee9692c-a80b-42f7-b4f9-6dc805077099", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "55910-460", "generic_name": "Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI", "labeler_name": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Cold and Flu", "brand_name_suffix": "Maximum Strength", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/20mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20270331", "marketing_start_date": "20180331"}