Home NDC 55758-056 Sanatos Nighttime Multi Symptoms
Product NDC 55758-056
11-digit product format 557580056
Labeler code 55758
Product ID 55758-056_0abf71d1-f688-1218-e063-6294a90a436c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
Dosage form LIQUID
Route ORAL
Labeler Pharmadel LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Sanatos Nighttime Multi Symptoms
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYLAMINE SUCCINATE 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL ACETAMINOPHEN 12.5 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V9BI9B5YI2 Internal UNII lookup 9D2RTI9KYH Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043400 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55758-056-25 Sanatos Nighttime Multi Symptoms 177 mL in 1 BOTTLE, PLASTIC LIQUID 177 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-056 SANATOS NIGHTTIME MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [PHARMADEL LLC] 2 Current NDC, 1 package rows 20231123_0ab188f3-f7f9-d665-e063-6294a90a198a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 85 · 1,687 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55758-056-25 55758005625 177 mL in 1 BOTTLE, PLASTIC (55758-056-25) 177 ml 2014-12-01 No No Current