Home NDC 50844-467 Sinus and Headache
Product NDC 50844-467
11-digit product format 508440467
Labeler code 50844
Product ID 50844-467_448f6ba2-0be3-4557-a64b-36636de255f9
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler L.N.K. International, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2005-07-26
Marketing end 2027-03-31
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 5 mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
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 Sinus and Headache
Brand name suffix Daytime Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D 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 1046378 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 50844-467-02 Sinus and HeadacheDaytime 1 in 1 CARTON TABLET, FILM COATED 1 11 50844-467-02 Sinus and HeadacheDaytime 12 in 1 BLISTER PACK TABLET, FILM COATED 12 11 50844-467-08 Sinus and HeadacheDaytime 2 in 1 CARTON TABLET, FILM COATED 2 11 50844-467-08 Sinus and HeadacheDaytime 12 in 1 BLISTER PACK TABLET, FILM COATED 12 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50844-467 SINUS AND HEADACHE DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 11 Current NDC, Legacy NDC, 4 package rows 20250423_e20b1093-d77f-4c39-b105-adaa1b82ea76.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 74 of 180 · 3,583 matching rows.
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 50844-467-02 50844046702 1 BLISTER PACK in 1 CARTON (50844-467-02) / 12 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2005-07-26 2027-03-31 No No Current 50844-467-08 50844046708 2 BLISTER PACK in 1 CARTON (50844-467-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-07-26 2027-03-31 No No Current