Home NDC 63824-947 Mucinex Childrens Cough and Congestion
Product NDC 63824-947
11-digit product format 638240947
Labeler code 63824
Product ID 63824-947_5219f3a4-ccd0-d4ae-e063-6294a90a26d2
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form SUSPENSION
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-03-30
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 63824-947 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63824-947 63824-947-11 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
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 Mucinex Childrens Cough and Congestion
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL GUAIFENESIN 100 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 63824-947-11 Mucinex Childrens Cough and Congestion 1 in 1 CARTON SUSPENSION 1 7 63824-947-11 Mucinex Childrens Cough and Congestion 201 mL in 1 BOTTLE SUSPENSION 201 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-947 MUCINEX CHILDRENS COUGH AND CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [RB HEALTH (US) LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241222_d9e5a8d7-814c-4ab1-bb05-e4cb9155978e.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 17 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GOOD NEIGHBOR PHARMACY Childrens Allergy Relief DIPHENHYDRAMINE HCL AMERISOURCE BERGEN c499574c-f32b-4608-bf8b-51ad44e35725 2026-07-13 Warnings Exact identifier application number: M012 Good NeighborChildrens Allergy Relief Bubblegum flavor DIPHENHYDRAMINE HCL AMERISOURCE BERGEN f442c61b-7d2c-401c-b862-acbe2282927b 2026-07-13 Warnings Exact identifier application number: M012 Sanatos MENTHOL Pharmadel LLC 5683b099-f029-2d08-e063-6394a90ad482 2026-07-13 Warnings Exact identifier application number: M012 Cold and Flu Relief Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) f673cdeb-4f8b-46b4-be92-c725d74abc55 2026-07-13 Warnings Exact identifier application number: M012 Cold Multi-Symptom ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ARMY AND AIR FORCE EXCHANGE SERVICE e4fca5ba-2d45-4c38-b0fd-297159d1705a 2026-07-13 Warnings Exact identifier application number: M012 Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion DEXTROMETHORPHAN HBR, GUAIFENESIN AMERISOURCE BERGEN 0269c0fd-0d8f-4264-9025-d4dcb3c45c60 2026-07-13 Warnings Exact identifier application number: M012 Propolis Cooling Relief Cherry Cough Drops MENTHOL, UNSPECIFIED FORM Beekeeper's Naturals USA Inc 7087566d-f24a-4508-aa25-7f42d055c43e 2026-07-13 Warnings Exact identifier application number: M012 Sinus Pressure and Congestion Relief DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL Rite Aid Corporation 35bcf263-3296-4d9c-84c0-146a173d6e87 2026-07-13 Warnings Exact identifier application number: M012 Good Neighbor Childrens Cough Relief Cherry Flavor DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN AMERISOURCE BERGEN a8e2fd43-b801-41ae-8d79-8ecf4a771543 2026-07-13 Warnings Exact identifier application number: M012 Good Neighbor No Drip Nasal Mist Extra Moisturizing OXYMETAZOLINE HYDROCHLORIDE AMERISOURCE BERGEN 7872aadd-b23c-431f-8048-24eece25ca2d 2026-07-13 Warnings Exact identifier application number: M012 Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN AMERISOURCE BERGEN 404a3521-8340-4476-a068-0e69cd0e514f 2026-07-13 Warnings Exact identifier application number: M012 Daytime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab5 2026-07-13 Warnings Exact identifier application number: M012 Good Neighbor Long Acting Cough Adult Tussin DEXTROMETHORPHAN HBR AMERISOURCE BERGEN df3c76bd-bd5b-42d7-a5f1-560fd3cba646 2026-07-13 Warnings Exact identifier application number: M012 Good Neighbor Adult Tussin Mucus and chest congestion GUAIFENESIN AMERISOURCE BERGEN 97e9cd18-dd55-4a26-80e3-4c17b9e1a1e8 2026-07-13 Warnings Exact identifier application number: M012 GOOD NEIGHBOR PHARMACY No Drip Nasal Mist OXYMETAZOLINE HYDROCHLORIDE AMERISOURCE BERGEN a217ca8a-1c00-4816-bc26-cc0f71c80c90 2026-07-13 Warnings Exact identifier application number: M012 Severe Congestion and Cough DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Walgreen Company 1ddc04fb-069c-44fe-814b-ba4f503c4be0 2026-07-10 Warnings Exact identifier application number: M012 COUGH DROPS- menthol granule MENTHOL GRANULE Anhui Jiuhe Health Industry Co., Ltd 5351b943-5830-e4e7-e063-6394a90a5b66 2026-07-10 Warnings Exact identifier application number: M012 ValuMeds Nasal Decongestant PE Phenylephrine PHENYLEPHRINE HYDROCHLORIDE Cabinet Health P.B.C. 3f284420-87c1-4c17-99e5-bc569bf9d45f 2026-07-10 Warnings Exact identifier application number: M012 Severe Congestion and Cough Multi-Symptom Maximum Strength DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL CVS Pharmacy 707eb066-cdfc-444b-833a-9d6d133d48e4 2026-07-10 Warnings Exact identifier application number: M012 Sinus Congestion PHENYLEPHRINE HCL L.N.K. International, Inc. 81f0276a-99a2-4a57-a0d8-224735aa8c79 2026-07-10 Warnings Exact identifier application number: M012
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63824-947-11 63824094711 1 BOTTLE in 1 CARTON (63824-947-11) / 201 mL in 1 BOTTLE 1 bottle 2018-03-30 0000-00-00 No No Current