Home NDC 51316-434 Tussin DM
Product NDC 51316-434
11-digit product format 513160434
Labeler code 51316
Product ID 51316-434_dde164b2-ddfc-431c-ad85-aceb11b0e1ea
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Doxylamine Succinate, Guaifenesin
Dosage form KIT
Route ORAL
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-18
Marketing end 2028-03-31
NDC exclude flag No
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 DM
Brand name suffix Daytime Nighttime Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020138 Internal RxNorm lookup 1115329 Internal RxNorm lookup 2056073 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 51316-434-19 Tussin DMDaytime Nighttime 1 in 1 PACKAGE, COMBINATION KIT 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-434 TUSSIN DM DAYTIME NIGHTTIME (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN) KIT [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] 3 Current NDC, 1 package rows 20240830_d59f6c64-8311-48ba-90d1-8000b04bfcda.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 98 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 Marketing end Sample Exclude flag Status 51316-434-19 51316043419 1 KIT in 1 PACKAGE, COMBINATION (51316-434-19) * 118 mL in 1 BOTTLE, PLASTIC * 118 mL in 1 BOTTLE, PLASTIC 1 kit 2023-04-18 2028-03-31 No No Historical