Home NDC 55505-217 Safetussin High Blood Pressure and diabetes
Product NDC 55505-217
11-digit product format 555050217
Labeler code 55505
Product ID 55505-217_df0f0e0c-323c-49e5-8432-c09cf950b20d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, and Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler KRAMER LABORATORIES
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-17
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 650; 20; 400 mg/30mL; mg/30mL; mg/30mL
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 Additional Listing Data#
Finished product Yes
Brand name base Safetussin High Blood Pressure and diabetes
Brand name suffix Cough, Cold and Flu
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL GUAIFENESIN 400 mg/30mL
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ Rxcui 1042695
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55505-217-36 Safetussin High Blood Pressure and diabetesCough, Cold and Flu 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55505-217 SAFETUSSIN HIGH BLOOD PRESSURE AND DIABETES COUGH, COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) LIQUID [KRAMER LABORATORIES] 3 Current NDC, 1 package rows 20241208_279e309c-040d-4001-808d-b7d986a9a1d8.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55505-217-36 55505021736 237 mL in 1 BOTTLE, PLASTIC (55505-217-36) 237 ml 2023-04-17 No No Historical