Home NDC 55758-311 SanaTos X
Product NDC 55758-311
11-digit product format 557580311
Labeler code 55758
Product ID 55758-311_0a1d578c-3260-6795-e063-6294a90a3142
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr,Guaifenesin, Phenylephrine HCI
Dosage form LIQUID
Route ORAL
Labeler Pharmadel LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-03
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650; 20; 400; 10 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base SanaTos X
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 650 mg/1 ACETAMINOPHEN 20 mg/1 GUAIFENESIN 400 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1593450 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 55758-311-06 SanaTos X 1 in 1 BOTTLE, WITH APPLICATOR LIQUID 1 2 55758-311-06 SanaTos X 1 in 1 BOX LIQUID 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-311 SANATOS X (ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [PHARMADEL LLC] 2 Current NDC, Legacy NDC, 2 package rows 20231115_85b8ef3d-7318-7f3b-e053-2991aa0a0777.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 84 · 1,678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55758-311-06 55758031106 1 BOTTLE, WITH APPLICATOR in 1 BOX (55758-311-06) / 1 LIQUID in 1 BOTTLE, WITH APPLICATOR 2018-12-03 0000-00-00 No No Current