Home NDC 51316-809 Pain, Headache and Congestion
Product NDC 51316-809
11-digit product format 513160809
Labeler code 51316
Product ID 51316-809_1d247756-17b5-4a31-83ad-40c0700cd1c7
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-29
Substance ACETAMINOPHEN; GUAIFENESIN
Active strength 325; 200 mg/1; mg/1
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 Pain, Headache and Congestion
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 GUAIFENESIN 200 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 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 602617 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 51316-809-09 Pain, Headache and Congestion 2 in 1 CARTON TABLET, FILM COATED 2 4 51316-809-09 Pain, Headache and Congestion 10 in 1 BLISTER PACK TABLET, FILM COATED 10 4
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 51316-809-09 51316080909 2 BLISTER PACK in 1 CARTON (51316-809-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2026-04-29 No No Current