nitetime

Generic: acetaminophen, dextromethorphan hbr, doxylamine succinate

Labeler: publix super markets inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nitetime
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate
Labeler publix super markets inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 30 mg/30mL, doxylamine succinate 12.5 mg/30mL

Manufacturer
Publix Super Markets Inc

Identifiers & Regulatory

Product NDC 56062-335
Product ID 56062-335_ae89ba68-4019-414d-80ef-6d27165e023b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2011-11-21

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 56062335
Hyphenated Format 56062-335

Supplemental Identifiers

RxCUI
1043400
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 nitetime (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 30 mg/30mL
  • 12.5 mg/30mL
source: ndc
Packaging
  • 355 mL in 1 BOTTLE (56062-335-40)
source: ndc

Packages (1)

56062-335-40 355 mL in 1 BOTTLE (56062-335-40)

Ingredients (3)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (30 mg/30mL) doxylamine succinate (12.5 mg/30mL)

Linked Drug Pages (1)

Nitetime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ae89ba68-4019-414d-80ef-6d27165e023b", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1043400"], "spl_set_id": ["8aa6492b-1723-4c6b-82ee-4f800301c6ad"], "manufacturer_name": ["Publix Super Markets Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE (56062-335-40)", "package_ndc": "56062-335-40", "marketing_start_date": "20140402"}], "brand_name": "Nitetime", "product_id": "56062-335_ae89ba68-4019-414d-80ef-6d27165e023b", "dosage_form": "SOLUTION", "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": "56062-335", "generic_name": "Acetaminophen, Dextromethorphan HBr, Doxylamine succinate", "labeler_name": "Publix Super Markets Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nitetime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/30mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20111121", "listing_expiration_date": "20261231"}