sanatos x

Generic: acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hci

Labeler: pharmadel llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sanatos x
Generic Name acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hci
Labeler pharmadel llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1, dextromethorphan hydrobromide 20 mg/1, guaifenesin 400 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Pharmadel LLC

Identifiers & Regulatory

Product NDC 55758-311
Product ID 55758-311_0a1d578c-3260-6795-e063-6294a90a3142
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2018-12-03

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55758311
Hyphenated Format 55758-311

Supplemental Identifiers

RxCUI
1593450
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

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 sanatos x (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hci (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
  • 20 mg/1
  • 400 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 BOX (55758-311-06) / 1 LIQUID in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (1)

55758-311-06 1 BOTTLE, WITH APPLICATOR in 1 BOX (55758-311-06) / 1 LIQUID in 1 BOTTLE, WITH APPLICATOR

Ingredients (4)

acetaminophen (650 mg/1) dextromethorphan hydrobromide (20 mg/1) guaifenesin (400 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

SanaTos X ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0a1d578c-3260-6795-e063-6294a90a3142", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1593450"], "spl_set_id": ["85b8ef3d-7318-7f3b-e053-2991aa0a0777"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Pharmadel LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 BOX (55758-311-06)  / 1 LIQUID in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "55758-311-06", "marketing_start_date": "20181203"}], "brand_name": "SanaTos X", "product_id": "55758-311_0a1d578c-3260-6795-e063-6294a90a3142", "dosage_form": "LIQUID", "pharm_class": ["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]"], "product_ndc": "55758-311", "generic_name": "Acetaminophen, Dextromethorphan HBr,Guaifenesin, Phenylephrine HCI", "labeler_name": "Pharmadel LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SanaTos X", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "GUAIFENESIN", "strength": "400 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20181203", "listing_expiration_date": "20261231"}