Home NDC 69729-787 Tesalon Jarabe Adulto
Product NDC 69729-787
11-digit product format 697290787
Labeler code 69729
Product ID 69729-787_5c3f80be-aab8-b7c3-e063-6394a90aa1b9
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Guaifenesin USP, Phenylephrine HCl
Dosage form SYRUP
Route ORAL
Labeler OPMX LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-27
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN
Active strength 500; 26.66; 10; 400 mg/20mL; mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tesalon Jarabe Adulto
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/20mL DEXTROMETHORPHAN HYDROBROMIDE 26.66 mg/20mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL GUAIFENESIN 400 mg/20mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69729-787-06 Tesalon Jarabe Adulto 177 mL in 1 BOTTLE, PLASTIC SYRUP 177 2 69729-787-06 Tesalon Jarabe Adulto 1 in 1 CARTON SYRUP 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-787 TESALON JARABE ADULTO (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN USP, PHENYLEPHRINE HCL) SYRUP [OPMX LLC] 2 Current NDC, 2 package rows 20241009_231c6455-4198-feec-e063-6394a90a8541.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69729-787-06 69729078706 1 BOTTLE, PLASTIC in 1 CARTON (69729-787-06) / 177 mL in 1 BOTTLE, PLASTIC 2024-09-27 No No Current