Home NDC 55301-446 Sinus Headache and Pain
Product NDC 55301-446
11-digit product format 553010446
Labeler code 55301
Product ID 55301-446_caa43cfa-0966-4ef7-8300-22435275f771
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ARMY AND AIR FORCE EXCHANGE SERVICE
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2005-07-26
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 Headache and Pain
Brand name suffix Day, Non-drowsy
Listing expiration 2027-12-31 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55301-446-08 Sinus Headache and PainDay, Non-drowsy 2 in 1 CARTON TABLET, FILM COATED 2 15 55301-446-08 Sinus Headache and PainDay, Non-drowsy 12 in 1 BLISTER PACK TABLET, FILM COATED 12 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55301-446 SINUS HEADACHE AND PAIN DAY, NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE] 14 Current NDC, Legacy NDC, 2 package rows 20250124_c33340c0-47d3-45e2-997b-3d9fb148900f.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 55301-446-08 55301044608 2 BLISTER PACK in 1 CARTON (55301-446-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-07-26 0000-00-00 No No Current