Home NDC 63868-868 Tussin DM Cough and Chest Congestion
Product NDC 63868-868
11-digit product format 638680868
Labeler code 63868
Product ID 63868-868_84556600-bfd3-4f17-872f-4b87b0a1ff65
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler QUALITY CHOICE (Chain Drug Marketing Association)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-09-30
Marketing end 2026-12-28
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 200 mg/10mL; mg/10mL
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
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 Cough and Chest Congestion
Brand name suffix Non Drowsy Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/10mL GUAIFENESIN 200 mg/10mL
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63868-868-54 Tussin DM Cough and Chest CongestionNon Drowsy 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 9 63868-868-54 Tussin DM Cough and Chest CongestionNon Drowsy 1 in 1 BOX LIQUID 1 9 63868-868-56 Tussin DM Cough and Chest CongestionNon Drowsy 1 in 1 BOX LIQUID 1 9 63868-868-56 Tussin DM Cough and Chest CongestionNon Drowsy 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3 GUAIFENESIN ACTIVE MOIETY 495W7451VQ TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3 WATER INACTIVE INGREDIENT 059QF0KO0R TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-868 TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 9 Current NDC, Legacy NDC, 4 package rows 20240502_5da9be32-9075-4eca-bb13-ce16330e39fa.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 · 3,550 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 63868-868-54 63868086854 1 BOTTLE, PLASTIC in 1 BOX (63868-868-54) / 118 mL in 1 BOTTLE, PLASTIC 2014-09-30 2026-12-28 No No Current 63868-868-56 63868086856 1 BOTTLE, PLASTIC in 1 BOX (63868-868-56) / 237 mL in 1 BOTTLE, PLASTIC 2014-09-30 2026-12-28 No No Current