Home NDC 49580-0385 Tussin DM Cough and Chest Congestion
Product NDC 49580-0385
11-digit product format 495800385
Labeler code 49580
Product ID 49580-0385_8228de33-953b-42ee-9bad-286bd3665934
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler P & L Development, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-03-31
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
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 Tussin DM Cough and Chest Congestion
Brand name suffix Adult
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/10mL GUAIFENESIN 200 mg/10mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1605844 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 49580-0385-2 Tussin DM Cough and Chest CongestionAdult 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 14 49580-0385-4 Tussin DM Cough and Chest CongestionAdult 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 14 49580-0385-4 Tussin DM Cough and Chest CongestionAdult 1 in 1 BOX LIQUID 1 14 49580-0385-8 Tussin DM Cough and Chest CongestionAdult 1 in 1 BOX LIQUID 1 14 49580-0385-8 Tussin DM Cough and Chest CongestionAdult 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 14
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 ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.] 1 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.] 1 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.] 1 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0385 TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC] 11 Current NDC, Legacy NDC, 5 package rows 20240127_4af67ba7-8892-442c-b9fb-80aba9140e05.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 131 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tussin Multi Symptom Cold CF DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE Best Choice (Valu Merchandisers Company) 539b8972-2a46-468e-ad27-6672d746feb7 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. db2ab9be-507d-4768-9d00-188f751b7726 2024-12-10 Warnings Exact identifier application number: M012 Adult Allergy Relief CALMCO ALLERGY RELIEF CalmCo 08288825-0f38-b6a3-e063-6394a90aa358 2024-12-07 Warnings Exact identifier application number: M012 Original Herb Cough Drops MENTHOL Ricola Ag c142663f-086e-4ab7-a758-9107d7077537 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 984c9793-163c-4b97-b244-9b471966a122 2024-12-05 Warnings Exact identifier application number: M012 BENZEDREX PROPYLHEXEDRINE BF ASCHER AND CO INC 00d8c237-3eee-1d9f-e063-6394a90aeb86 2024-12-05 Warnings Exact identifier application number: M012 Cold Multi Symptom Daytime Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE Chain Drug Marketing Association d5cbb5b0-564c-429e-b680-fa683e796393 2024-12-05 Warnings Exact identifier application number: M012 Cold Relief Multi-Symptom ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCare de8a623f-7b10-4d56-a74b-3737e7716ffe 2024-12-05 Warnings Exact identifier application number: M012 Cold Max Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 9773958b-c5e5-4da7-a8e9-6b6c223a2b30 2024-12-05 Warnings Exact identifier application number: M012 Cold Plus Head Congestion Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 399e0e51-c2a7-451c-b74d-d3db140cef69 2024-12-05 Warnings Exact identifier application number: M012 Head Congestion Plus Mucus PE ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE United Natural Foods, Inc. dba UNFI 09531edc-8dbd-451f-ae02-f922e9e8c248 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 71ca8af7-172d-40da-be1e-ff3ab5568e74 2024-12-05 Warnings Exact identifier application number: M012 SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola Ag b790a91c-33be-4bc3-bdeb-eae6f366f085 2024-12-05 Warnings Exact identifier application number: M012 EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola Ag ea42e516-2ef8-41c9-ae4e-571f0147bc6b 2024-12-05 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola Ag 8b2d5c0f-509e-447d-b071-d73c4785f120 2024-12-05 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola Ag 8ae0e21a-44a0-4a2c-9880-54eeeaea07ea 2024-12-05 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 6d82469b-d51c-4824-9830-6c1874ad4fe4 2024-12-05 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola Ag e8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce5 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag a535717d-ba55-45e9-9fc3-711b5d7dbf57 2024-12-05 Warnings Exact identifier application number: M012 THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL Ricola Ag 4330ee8d-0b37-4a93-886b-5fc6e6598da7 2024-12-05 Warnings Exact identifier application number: M012
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 49580-0385-2 49580038502 118 mL in 1 BOTTLE, PLASTIC (49580-0385-2) 118 ml 2015-03-31 0000-00-00 No No Current 49580-0385-4 49580038504 1 BOTTLE, PLASTIC in 1 BOX (49580-0385-4) / 118 mL in 1 BOTTLE, PLASTIC 2015-03-31 0000-00-00 No No Current 49580-0385-8 49580038508 1 BOTTLE, PLASTIC in 1 BOX (49580-0385-8) / 237 mL in 1 BOTTLE, PLASTIC 2015-03-31 0000-00-00 No No Current