Home NDC 55505-220 SAFETUSSIN Non Drowsy
Product NDC 55505-220
11-digit product format 555050220
Labeler code 55505
Product ID 55505-220_cff65bfa-6667-4ecf-a98c-a93b50d2d161
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, and Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler KRAMER LABORATORIES
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10; 100 mg/5mL; mg/5mL
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2026-12-31
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 SAFETUSSIN Non Drowsy
Brand name suffix Cough plus chest congestion
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL GUAIFENESIN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII 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 55505-220-33 SAFETUSSIN Non DrowsyCough plus chest congestion 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 5 55505-220-36 SAFETUSSIN Non DrowsyCough plus chest congestion 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55505-220 SAFETUSSIN NON DROWSY COUGH PLUS CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) LIQUID [KRAMER LABORATORIES] 4 Current NDC, 2 package rows 20241208_60311ca3-8544-417e-aa29-e9f65c6692ba.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 73 of 177 · 3,534 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55505-220-33 55505022033 118 mL in 1 BOTTLE, PLASTIC (55505-220-33) 118 ml 2025-07-01 No No Current 55505-220-36 55505022036 237 mL in 1 BOTTLE, PLASTIC (55505-220-36) 237 ml 2023-06-01 No No Current