nitetime cold and flu (49035-044)

Drug Facts

Product Profile

Brand Name nitetime cold and flu

Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate

Labeler equate (wal-mart stores, inc.) (see also wal-mart inc)

Dosage Form LIQUID

Routes

ORAL

Active Ingredients

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

Manufacturer

EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)

Identifiers & Regulatory

Product NDC 49035-044

Product ID 49035-044_c89a3a3d-c54f-4577-ba38-61360cc7487f

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2014-12-31

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 49035044

Hyphenated Format 49035-044

Supplemental Identifiers

RxCUI

1043400

UPC

0681131036757

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 cold and flu (source: ndc)

Generic Name acetaminophen, dextromethorphan hydrobromide, 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, PLASTIC (49035-044-12)
2 BOTTLE, PLASTIC in 1 PACKAGE (49035-044-24) / 355 mL in 1 BOTTLE, PLASTIC

source: ndc

Packages (2)

49035-044-12 355 mL in 1 BOTTLE, PLASTIC (49035-044-12) 49035-044-24 2 BOTTLE, PLASTIC in 1 PACKAGE (49035-044-24) / 355 mL in 1 BOTTLE, PLASTIC

Ingredients (3)

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

Linked Drug Pages (1)

NiteTime Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "c89a3a3d-c54f-4577-ba38-61360cc7487f", "openfda": {"upc": ["0681131036757"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1043400"], "spl_set_id": ["7b3c4793-9369-4331-bd5a-40f20b9df2b0"], "manufacturer_name": ["EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE, PLASTIC (49035-044-12)", "package_ndc": "49035-044-12", "marketing_start_date": "20141231"}, {"sample": false, "description": "2 BOTTLE, PLASTIC in 1 PACKAGE (49035-044-24)  / 355 mL in 1 BOTTLE, PLASTIC", "package_ndc": "49035-044-24", "marketing_start_date": "20141231"}], "brand_name": "NiteTime Cold and Flu", "product_id": "49035-044_c89a3a3d-c54f-4577-ba38-61360cc7487f", "dosage_form": "LIQUID", "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": "49035-044", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate", "labeler_name": "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NiteTime Cold and Flu", "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": "20141231", "listing_expiration_date": "20261231"}