Home NDC 36800-037 Mucus Relief Severe Congestion and Cough
Product NDC 36800-037
11-digit product format 368000037
Labeler code 36800
Product ID 36800-037_1ae06753-b458-429f-906a-0c4ecb463efc
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler TOP CARE (Topco Associates LLC)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-02-28
Marketing end 2026-12-28
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 20; 400; 10 mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Mucus Relief Severe Congestion and Cough
Brand name suffix Maximum Strength Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 400 mg/20mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL
Harmonized Identifiers# Field, Values table Field Values Unii 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ Rxcui 1043543
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-037-06 Mucus Relief Severe Congestion and CoughMaximum Strength 177 mL in 1 BOTTLE, PLASTIC LIQUID 177 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 PROPYL GALLATE INACTIVE INGREDIENT 8D4SNN7V92 MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 WATER INACTIVE INGREDIENT 059QF0KO0R MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-037 MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] 6 Current NDC, Legacy NDC, 1 package rows 20231014_98dd0ba6-0109-46b2-92df-11a030984240.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 36800-037-06 36800003706 177 mL in 1 BOTTLE, PLASTIC (36800-037-06) 177 ml 2015-02-28 2026-12-28 No No Current