maximum strength nighttime severe cold and flu

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

Labeler: prodose, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name maximum strength nighttime severe cold and flu
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
Labeler prodose, inc.
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
Prodose, Inc.

Identifiers & Regulatory

Product NDC 68210-4210
Product ID 68210-4210_34c5c0c9-71c9-9151-e063-6294a90a0f44
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-08-19

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 682104210
Hyphenated Format 68210-4210

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 maximum strength nighttime severe cold and flu (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
  • 1 BLISTER PACK in 1 CARTON (68210-4210-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

68210-4210-1 1 BLISTER PACK in 1 CARTON (68210-4210-1) / 10 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)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "34c5c0c9-71c9-9151-e063-6294a90a0f44", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["1297288"], "spl_set_id": ["c3d0b70f-d213-4e38-88ab-1c89d93a391d"], "manufacturer_name": ["Prodose, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68210-4210-1)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "68210-4210-1", "marketing_start_date": "20220819"}], "brand_name": "Maximum Strength Nighttime Severe Cold and Flu", "product_id": "68210-4210_34c5c0c9-71c9-9151-e063-6294a90a0f44", "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": "68210-4210", "generic_name": "Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride", "labeler_name": "Prodose, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Maximum Strength Nighttime Severe 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"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220819", "listing_expiration_date": "20261231"}