tesalon children

Generic: acetaminophen, dextromethorphan hbr, guafeisin usp, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name tesalon children
Generic Name acetaminophen, dextromethorphan hbr, guafeisin usp, phenylephrine hcl
Labeler opmx llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/10mL, dextromethorphan hydrobromide 13.33 mg/10mL, guaifenesin 200 mg/10mL, phenylephrine hydrochloride 5 mg/10mL

Manufacturer
OPMX LLC

Identifiers & Regulatory

Product NDC 69729-786
Product ID 69729-786_2309620a-ccbd-41e9-e063-6394a90a9520
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-09-27

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 69729786
Hyphenated Format 69729-786

Supplemental Identifiers

RxCUI
1790651
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 tesalon children (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, guafeisin usp, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/10mL
  • 13.33 mg/10mL
  • 200 mg/10mL
  • 5 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (69729-786-06) / 177 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

69729-786-06 1 BOTTLE, PLASTIC in 1 CARTON (69729-786-06) / 177 mL in 1 BOTTLE, PLASTIC

Ingredients (4)

acetaminophen (250 mg/10mL) dextromethorphan hydrobromide (13.33 mg/10mL) guaifenesin (200 mg/10mL) phenylephrine hydrochloride (5 mg/10mL)

Linked Drug Pages (1)

Tesalon Children ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2309620a-ccbd-41e9-e063-6394a90a9520", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1790651"], "spl_set_id": ["2309620a-ccbc-41e9-e063-6394a90a9520"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["OPMX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (69729-786-06)  / 177 mL in 1 BOTTLE, PLASTIC", "package_ndc": "69729-786-06", "marketing_start_date": "20240927"}], "brand_name": "Tesalon Children", "product_id": "69729-786_2309620a-ccbd-41e9-e063-6394a90a9520", "dosage_form": "SYRUP", "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": "69729-786", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guafeisin USP, Phenylephrine HCl", "labeler_name": "OPMX LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tesalon Children", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "13.33 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": "20240927", "listing_expiration_date": "20261231"}