sanatos mucus relief cold toddlers

Generic: dextromethorphan hbr, guaifenesin

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

Drug Facts

Product Profile

Brand Name sanatos mucus relief cold toddlers
Generic Name dextromethorphan hbr, guaifenesin
Labeler pharmadel llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 2.5 mg/2.5mL, guaifenesin 50 mg/2.5mL

Manufacturer
Pharmadel LLC

Identifiers & Regulatory

Product NDC 55758-307
Product ID 55758-307_2d58d9b1-2c02-42e2-e063-6294a90a205c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2017-10-17

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 55758307
Hyphenated Format 55758-307

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 mucus relief cold toddlers (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/2.5mL
  • 50 mg/2.5mL
source: ndc
Packaging
  • 59 mL in 1 BOTTLE, WITH APPLICATOR (55758-307-02)
source: ndc

Packages (1)

55758-307-02 59 mL in 1 BOTTLE, WITH APPLICATOR (55758-307-02)

Ingredients (2)

dextromethorphan hydrobromide (2.5 mg/2.5mL) guaifenesin (50 mg/2.5mL)

Linked Drug Pages (1)

SanaTos Mucus Relief Cold Toddlers ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d58d9b1-2c02-42e2-e063-6294a90a205c", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1020138"], "spl_set_id": ["60672feb-1421-651e-e053-2a91aa0af41d"], "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": "59 mL in 1 BOTTLE, WITH APPLICATOR (55758-307-02)", "package_ndc": "55758-307-02", "marketing_start_date": "20171017"}], "brand_name": "SanaTos Mucus Relief Cold Toddlers", "product_id": "55758-307_2d58d9b1-2c02-42e2-e063-6294a90a205c", "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": "55758-307", "generic_name": "Dextromethorphan HBr, Guaifenesin", "labeler_name": "Pharmadel LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SanaTos Mucus Relief Cold Toddlers", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "2.5 mg/2.5mL"}, {"name": "GUAIFENESIN", "strength": "50 mg/2.5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20171017", "listing_expiration_date": "20261231"}