sanatos x children

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

acetaminophen 325 mg/10mL, dextromethorphan hydrobromide 10 mg/10mL, guaifenesin 200 mg/10mL, phenylephrine hydrochloride 5 mg/10mL

Manufacturer
Pharmadel LLC

Identifiers & Regulatory

Product NDC 55758-443
Product ID 55758-443_1fc1408c-c541-39ab-e063-6394a90aa477
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-08-01

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 55758443
Hyphenated Format 55758-443

Supplemental Identifiers

RxCUI
1116572
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 children (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/10mL
  • 10 mg/10mL
  • 200 mg/10mL
  • 5 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (55758-443-04) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

55758-443-04 1 BOTTLE, PLASTIC in 1 CARTON (55758-443-04) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (4)

acetaminophen (325 mg/10mL) dextromethorphan hydrobromide (10 mg/10mL) guaifenesin (200 mg/10mL) phenylephrine hydrochloride (5 mg/10mL)

Linked Drug Pages (1)

SanaTos X Children ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1fc1408c-c541-39ab-e063-6394a90aa477", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1116572"], "spl_set_id": ["1fc1408c-c540-39ab-e063-6394a90aa477"], "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, PLASTIC in 1 CARTON (55758-443-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "55758-443-04", "marketing_start_date": "20240801"}], "brand_name": "SanaTos X Children", "product_id": "55758-443_1fc1408c-c541-39ab-e063-6394a90aa477", "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": "55758-443", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCi", "labeler_name": "Pharmadel LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SanaTos X Children", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240801", "listing_expiration_date": "20261231"}