Home NDC 50580-447-01 SUDAFED PE Head Congestion Plus Mucus
Product NDC 50580-447
Requested package NDC 50580-447-01
11-digit product format 505800447
Labeler code 50580
Product ID 50580-447_21bd70b6-1f2f-75bc-e063-6294a90a61f3
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, guaifenesin, and phenylephrine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-06-17
Substance ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 SUDAFED PE Head Congestion Plus Mucus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 GUAIFENESIN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1243679 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-447-01 SUDAFED PE Head Congestion Plus Mucus 12 in 1 BLISTER PACK TABLET, FILM COATED 12 8 50580-447-01 SUDAFED PE Head Congestion Plus Mucus 2 in 1 CARTON TABLET, FILM COATED 2 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-447 SUDAFED PE HEAD CONGESTION PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] 8 Current NDC, Legacy NDC, 2 package rows 20241109_f0739186-41b9-4761-adf7-08101b30a18e.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
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 50580-447-01 50580044701 2 BLISTER PACK in 1 CARTON (50580-447-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2019-06-17 0000-00-00 No No Current