Home NDC 0904-6537 Tussin Multi Symptom Cold CF
Product NDC 0904-6537
11-digit product format 009046537
Labeler code 0904
Product ID 0904-6537_7bcf4ed4-fdc2-4408-bc9b-ebbdae3aee70
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin, Phenylephrine
Dosage form LIQUID
Route ORAL
Labeler Major Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-11-30
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 20; 200; 10 mg/10mL; mg/10mL; mg/10mL
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 Tussin Multi Symptom Cold CF
Brand name suffix Adult
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/10mL GUAIFENESIN 200 mg/10mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1044949 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-6537-20 Tussin Multi Symptom Cold CFAdult 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 9 0904-6537-20 Tussin Multi Symptom Cold CFAdult 1 in 1 BOX LIQUID 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6537 TUSSIN MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [MAJOR PHARMACEUTICALS] 8 Current NDC, Legacy NDC, 2 package rows 20241030_a9958b7d-7060-422b-a098-c1925c246081.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 Marketing end Sample Exclude flag Status 0904-6537-20 00904653720 1 BOTTLE, PLASTIC in 1 BOX (0904-6537-20) / 118 mL in 1 BOTTLE, PLASTIC 2015-11-30 0000-00-00 No No Current