Home NDC 70000-0080 Sinus Relief Severe Congestion and Pain
Product NDC 70000-0080
11-digit product format 700000080
Labeler code 70000
Product ID 70000-0080_45ada5e4-1b7f-c75b-e063-6394a90ae3d4
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler CARDINAL HEALTH
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-27
Marketing end 2028-02-28
Substance ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
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 Relief Severe Congestion and Pain Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 GUAIFENESIN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 495W7451VQ 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 1243679 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 70000-0080-1 Sinus Relief Severe Congestion and Pain 10 in 1 BLISTER PACK TABLET, COATED 10 5 70000-0080-1 Sinus Relief Severe Congestion and Pain 2 in 1 CARTON TABLET, COATED 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0080 SINUS RELIEF SEVERE CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CARDINAL HEALTH] 4 Current NDC, Legacy NDC, 2 package rows 20231111_645f8075-e33f-4e1a-9249-7368261cdcb9.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 70000-0080-1 70000008001 2 BLISTER PACK in 1 CARTON (70000-0080-1) / 10 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2021-01-27 2028-02-28 No No Current