Home NDC 0363-4050 Cough Cold and Sore Throat
Product NDC 0363-4050
11-digit product format 003634050
Labeler code 0363
Product ID 0363-4050_5913a9bc-b821-42ea-977d-431691b1ebcf
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler Walgreens
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-10-31
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL
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
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 Cough Cold and Sore Throat
Brand name suffix Childrens
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL GUAIFENESIN 200 mg/10mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1116572 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 0363-4050-04 Cough Cold and Sore ThroatChildrens 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 8 0363-4050-04 Cough Cold and Sore ThroatChildrens 1 in 1 BOX LIQUID 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 PROPYL GALLATE INACTIVE INGREDIENT 8D4SNN7V92 COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-4050 COUGH COLD AND SORE THROAT CHILDRENS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 8 Current NDC, Legacy NDC, 2 package rows 20240509_400a0998-e276-4c8d-9b41-145b1b405fff.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 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Menthol Drops Dollar General Severe Honey Lemon 45ct MENTHOL Dollar General Corporation 0ea61a4c-690a-4349-9952-cc17fb1f0671 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Dollar General Menthol 30ct MENTHOL Dollar General Corporation 892092cc-5a1c-4309-baf9-a040888d3577 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Dollar General Menthol 80ct MENTHOL Dollar General Corporation 773f4ad2-6c91-431f-ad3d-c0e53e7ca918 2025-10-08 Warnings Exact identifier application number: M012 Menthol Drops Dollar General Severe 45ct MENTHOL Dollar General Corporation 13c7d3b1-12ac-4931-877c-728d3d89942c 2025-10-08 Warnings Exact identifier application number: M012 Menthol Drops Dollar General Severe Honey Lemon 45ct MENTHOL Dollar General Corporation d0c878f0-a737-4583-9847-834af70e7d6f 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Freegells Strawberry 30ct MENTHOL R.L. ALBERT & SON, INC dc077c36-c403-4b83-894a-e9922e928841 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Freegells Strawberry 30ct MENTHOL RL Albert & Son Inc. 2ea760f3-df50-4c46-a43d-d5ed07f421a5 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Honey Lemon 200ct MENTHOL RL Albert & Son Inc. 3ac08274-08d9-4dab-b09a-6e297948a25a 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Honey Lemon 30ct MENTHOL RL Albert & Son Inc. 8114e1a2-728d-4489-a494-f28a5e7d9bb3 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 30ct MENTHOL RL Albert & Son Inc. 0c2e594a-cdf8-4595-bda6-0ebc19ac3850 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 200ct MENTHOL R.L. ALBERT & SON, INC f62b7f75-3275-46c9-880c-64148d0dce59 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 80ct MENTHOL R.L. ALBERT & SON, INC 15917bfb-f660-4a12-bdcc-5b4a96e0e1d0 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 30ct MENTHOL RL Albert & Son Inc. 92c54c53-c8bb-4576-abae-715a2f3878bf 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 80ct MENTHOL RL Albert & Son Inc. c96cc162-5908-4990-9dc1-3ce912844274 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 30ct MENTHOL R.L. ALBERT & SON, INC bac77712-6197-4b30-a5f8-9b99eb9d7b5a 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL R.L. ALBERT & SON, INC 6842d766-ade6-40b2-831b-f4feac25c6db 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL RL Albert & Son Inc. 9f324ca1-0e2a-47e3-997e-2aaa68a85751 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 30ct MENTHOL R.L. ALBERT & SON, INC 2063a013-aa0b-465d-b04f-cfe2e70d749f 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 200ct MENTHOL R.L. ALBERT & SON, INC cd81488c-74d8-48d9-9c73-ff662a5cd4cd 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 80ct MENTHOL R.L. ALBERT & SON, INC 61deea94-d0a9-4563-926b-53f255a7c425 2025-10-08 Warnings Exact identifier application number: M012
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 0363-4050-04 00363405004 1 BOTTLE, PLASTIC in 1 BOX (0363-4050-04) / 118 mL in 1 BOTTLE, PLASTIC 2014-10-31 0000-00-00 No No Current