Home NDC 0031-8719 Robitussin Maximum Strength Cough Plus Chest Congestion DM
Product NDC 0031-8719
11-digit product format 000318719
Labeler code 0031
Product ID 0031-8719_cb5018d5-8b32-41b8-a393-008d092d4638
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan hydrobromide and guaifenesin
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-05-23
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10; 200 mg/1; mg/1
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 Additional Listing Data#
Finished product Yes
Brand name base Robitussin Maximum Strength Cough Plus Chest Congestion DM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 9D2RTI9KYH, 495W7451VQ Rxcui 1111663
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0031-8719-10 Robitussin Maximum Strength Cough Plus Chest Congestion DM 2 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 2 11 0031-8719-10 Robitussin Maximum Strength Cough Plus Chest Congestion DM 5 in 1 CARTON CAPSULE, LIQUID FILLED 5 11 0031-8719-20 Robitussin Maximum Strength Cough Plus Chest Congestion DM 10 in 1 CARTON CAPSULE, LIQUID FILLED 10 11 0031-8719-20 Robitussin Maximum Strength Cough Plus Chest Congestion DM 2 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 2 11 0031-8719-31 Robitussin Maximum Strength Cough Plus Chest Congestion DM 15 in 1 CARTON CAPSULE, LIQUID FILLED 15 11 0031-8719-31 Robitussin Maximum Strength Cough Plus Chest Congestion DM 2 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 2 11 0031-8719-70 Robitussin Maximum Strength Cough Plus Chest Congestion DM 500 in 1 BOX CAPSULE, LIQUID FILLED 500 11 0031-8719-70 Robitussin Maximum Strength Cough Plus Chest Congestion DM 2 in 1 POUCH CAPSULE, LIQUID FILLED 2 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH] 2 LIGHT MINERAL OIL INACTIVE INGREDIENT N6K5787QVP ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH] 2 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-8719 ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC] 10 Current NDC, Legacy NDC, 8 package rows 20240316_868ac65a-63e2-46ac-b87d-66b289086756.zip
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 0031-8719-10 00031871910 5 BLISTER PACK in 1 CARTON (0031-8719-10) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 5 blister pack 2016-05-02 0000-00-00 No No Current 0031-8719-20 00031871920 10 BLISTER PACK in 1 CARTON (0031-8719-20) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 10 blister pack 2013-05-23 0000-00-00 No No Current 0031-8719-31 00031871931 15 in 1 CARTON Historical 0031-8719-70 00031871970 500 in 1 BOX Historical