nighttime cold and flu relief

Generic: acetaminophen, dextromethorphan hbr and doxylamine succinate

Labeler: salado sales inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime cold and flu relief
Generic Name acetaminophen, dextromethorphan hbr and doxylamine succinate
Labeler salado sales inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 15 mg/1, doxylamine succinate 6.25 mg/1

Manufacturer
SALADO SALES INC.

Identifiers & Regulatory

Product NDC 57243-603
Product ID 57243-603_8b66b154-1c8f-4d1c-a08d-fb9c142b630f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2025-12-23

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 57243603
Hyphenated Format 57243-603

Supplemental Identifiers

RxCUI
1094549
UPC
0761706169087
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 nighttime cold and flu relief (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr and doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 15 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 24 BLISTER PACK in 1 CARTON (57243-603-03) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

57243-603-03 24 BLISTER PACK in 1 CARTON (57243-603-03) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (15 mg/1) doxylamine succinate (6.25 mg/1)

Linked Drug Pages (1)

Nighttime Cold and Flu Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8b66b154-1c8f-4d1c-a08d-fb9c142b630f", "openfda": {"upc": ["0761706169087"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1094549"], "spl_set_id": ["cc73b668-cc6a-41d6-800a-4988c59c0449"], "manufacturer_name": ["SALADO SALES INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (57243-603-03)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "57243-603-03", "marketing_start_date": "20251223"}], "brand_name": "Nighttime Cold and Flu Relief", "product_id": "57243-603_8b66b154-1c8f-4d1c-a08d-fb9c142b630f", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "57243-603", "generic_name": "Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate", "labeler_name": "SALADO SALES INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Cold and Flu Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251223", "listing_expiration_date": "20271231"}