Home NDC 53943-323 SINUS AND HEADACHE
Product NDC 53943-323
11-digit product format 539430323
Labeler code 53943
Product ID 53943-323_24adcdf2-1434-b681-e063-6394a90a9b02
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler DISCOUNT DRUG MART
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-09-01
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 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 SINUS AND HEADACHE
Listing expiration 2026-12-31 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 53943-323-05 SINUS AND HEADACHE 12 in 1 BLISTER PACK TABLET, COATED 12 4 53943-323-05 SINUS AND HEADACHE 2 in 1 CARTON TABLET, COATED 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53943-323 SINUS AND HEADACHE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [DISCOUNT DRUG MART] 4 Current NDC, Legacy NDC, 2 package rows 20241019_a7e99dad-5916-6a90-e053-2a95a90a8803.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 73 of 178 · 3,550 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 53943-323-05 53943032305 2 BLISTER PACK in 1 CARTON (53943-323-05) / 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2020-09-01 0000-00-00 No No Current