Home NDC 55505-221 Safetussin PM Nighttime
Product NDC 55505-221
11-digit product format 555050221
Labeler code 55505
Product ID 55505-221_b7fd290f-7f8e-430f-8bbf-b5aeea4181de
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Doxylamine Succinate
Dosage form LIQUID
Route ORAL
Labeler Kramer Laboratories
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-28
Substance DEXTROMETHORPHAN; DOXYLAMINE SUCCINATE
Active strength 7.5; 3.125 mg/5mL; mg/5mL
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 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 Safetussin PM Nighttime
Brand name suffix Cough relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN 7.5 mg/5mL DOXYLAMINE SUCCINATE 3.125 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7355X3ROTS Internal UNII lookup V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1115329 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 55505-221-33 Safetussin PM NighttimeCough relief 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 4 55505-221-33 Safetussin PM NighttimeCough relief 1 in 1 CARTON LIQUID 1 4 55505-221-36 Safetussin PM NighttimeCough relief 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 4 55505-221-36 Safetussin PM NighttimeCough relief 1 in 1 CARTON LIQUID 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55505-221 SAFETUSSIN PM NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KRAMER LABORATORIES] 3 Current NDC, 4 package rows 20240630_33dd2245-9abd-4b32-ac76-0f45a54c0f33.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 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55505-221-33 55505022133 118 mL in 1 BOTTLE, PLASTIC 118 ml Historical 55505-221-36 55505022136 1 BOTTLE, PLASTIC in 1 CARTON (55505-221-36) / 237 mL in 1 BOTTLE, PLASTIC 2023-07-28 No No Current