Home NDC 55319-496 Sinus and Headache
Product NDC 55319-496
11-digit product format 553190496
Labeler code 55319
Product ID 55319-496_080f22ce-cfa2-44ac-92bb-75af97258ee5
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Family Dollar Services Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-02
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
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 Sinus and Headache
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55319-496-08 Sinus and Headache 12 in 1 BLISTER PACK TABLET, FILM COATED 12 3 55319-496-08 Sinus and Headache 2 in 1 CARTON TABLET, FILM COATED 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-496 SINUS AND HEADACHE (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [FAMILY DOLLAR SERVICES INC] 2 Current NDC, 2 package rows 20250110_a0d46b6a-5742-4363-8d55-b485bd6ca281.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 97 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55319-496-08 55319049608 2 BLISTER PACK in 1 CARTON (55319-496-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2024-01-02 No No Current