Home NDC 46122-443 Sinus Pressure Pain
Product NDC 46122-443
11-digit product format 461220443
Labeler code 46122
Product ID 46122-443_7e5d6a41-1b87-49dc-871f-6f760562f645
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Phenylephrine HCl
Dosage form TABLET
Route ORAL
Labeler Amerisource Bergen
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2005-06-23
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 Pressure Pain
Brand name suffix Maximum Strength, Non-Drowsy
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 46122-443-62 Sinus Pressure PainMaximum Strength, Non-Drowsy 12 in 1 BLISTER PACK TABLET 12 11 46122-443-62 Sinus Pressure PainMaximum Strength, Non-Drowsy 2 in 1 CARTON TABLET 2 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46122-443 SINUS PRESSURE PAIN MAXIMUM STRENGTH, NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [AMERISOURCE BERGEN] 10 Current NDC, Legacy NDC, 2 package rows 20241108_467df7de-8cf4-411d-9fd2-8b102d927832.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 46122-443-62 46122044362 2 BLISTER PACK in 1 CARTON (46122-443-62) / 12 TABLET in 1 BLISTER PACK 2 blister pack 2005-06-23 0000-00-00 No No Current