Home NDC 70000-0083 Head Congestion and Mucus
Product NDC 70000-0083
11-digit product format 700000083
Labeler code 70000
Product ID 70000-0083_0e652c85-f0df-4060-888b-c98a6e9e2a05
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cardinal Health 110, LLC. DBA Leader
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-11
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
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 Head Congestion and Mucus
Listing expiration 2027-12-31 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 70000-0083-1 Head Congestion and Mucus 2 in 1 CARTON TABLET, FILM COATED 2 9 70000-0083-1 Head Congestion and Mucus 12 in 1 BLISTER PACK TABLET, FILM COATED 12 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0083 HEAD CONGESTION AND MUCUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER] 8 Current NDC, Legacy NDC, 2 package rows 20240704_7418d92d-a540-40d6-91d0-b7eb1f87f8ff.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 70000-0083-1 70000008301 2 BLISTER PACK in 1 CARTON (70000-0083-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2021-03-11 0000-00-00 No No Current