Home NDC 51316-317 SINUS AND NASAL DECONGESTANT
Product NDC 51316-317
11-digit product format 513160317
Labeler code 51316
Product ID 51316-317_06ffc40d-8441-46fd-abec-29196884df21
Type HUMAN OTC DRUG
Nonproprietary name Pseudoephedrine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-11-20
Substance PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 30 mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-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 NASAL DECONGESTANT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049160 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 51316-317-62 SINUS AND NASAL DECONGESTANT 2 in 1 CARTON TABLET, FILM COATED 2 3 51316-317-62 SINUS AND NASAL DECONGESTANT 12 in 1 BLISTER PACK TABLET, FILM COATED 12 3 51316-317-80 SINUS AND NASAL DECONGESTANT 12 in 1 BLISTER PACK TABLET, FILM COATED 12 3 51316-317-80 SINUS AND NASAL DECONGESTANT 8 in 1 CARTON TABLET, FILM COATED 8 3
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 Sample Exclude flag Status 51316-317-62 51316031762 2 BLISTER PACK in 1 CARTON (51316-317-62) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2025-12-12 No No Current 51316-317-80 51316031780 8 BLISTER PACK in 1 CARTON (51316-317-80) / 12 TABLET, FILM COATED in 1 BLISTER PACK 8 blister pack 2025-11-20 No No Current