sanatos children cough and congestion cherry

Generic: dextromethorphan hbr and guaifenesin

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

Drug Facts

Product Profile

Brand Name sanatos children cough and congestion cherry
Generic Name dextromethorphan hbr and guaifenesin
Labeler pharmadel llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 5 mg/5mL, guaifenesin 100 mg/5mL

Manufacturer
Pharmadel LLC

Identifiers & Regulatory

Product NDC 55758-013
Product ID 55758-013_177ee8db-2b19-2923-e063-6294a90a1c7b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2016-01-01

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 55758013
Hyphenated Format 55758-013

Supplemental Identifiers

RxCUI
1020138
UNII
9D2RTI9KYH 495W7451VQ
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 children cough and congestion cherry (source: ndc)
Generic Name dextromethorphan hbr and guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 BOX (55758-013-04) / 118 mL in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (1)

55758-013-04 1 BOTTLE, WITH APPLICATOR in 1 BOX (55758-013-04) / 118 mL in 1 BOTTLE, WITH APPLICATOR

Ingredients (2)

dextromethorphan hydrobromide (5 mg/5mL) guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

SanaTos Children Cough and Congestion Cherry ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "177ee8db-2b19-2923-e063-6294a90a1c7b", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1020138"], "spl_set_id": ["60437d86-9e13-8d8a-e053-2991aa0a2317"], "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 (55758-013-04)  / 118 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "55758-013-04", "marketing_start_date": "20160101"}], "brand_name": "SanaTos Children Cough and Congestion Cherry", "product_id": "55758-013_177ee8db-2b19-2923-e063-6294a90a1c7b", "dosage_form": "LIQUID", "pharm_class": ["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]"], "product_ndc": "55758-013", "generic_name": "DEXTROMETHORPHAN HBr and GUAIFENESIN", "labeler_name": "Pharmadel LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SanaTos Children Cough and Congestion Cherry", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160101", "listing_expiration_date": "20261231"}