Home NDC 46122-415 Cold Head Congestion Severe
Product NDC 46122-415
11-digit product format 461220415
Labeler code 46122
Product ID 46122-415_24c4b809-f53e-6fe2-e063-6394a90a608f
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler AmeriSource Bergen
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-02-01
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 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 Cold Head Congestion Severe
Listing expiration 2026-12-31 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 46122-415-62 Cold Head Congestion Severe 12 in 1 BLISTER PACK TABLET, COATED 12 4 46122-415-62 Cold Head Congestion Severe 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 46122-415 COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERISOURCE BERGEN] 4 Current NDC, Legacy NDC, 2 package rows 20241020_604d7e53-4bfd-4cdd-aed2-b304ae82ce44.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 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 Marketing end Sample Exclude flag Status 46122-415-62 46122041562 2 BLISTER PACK in 1 CARTON (46122-415-62) / 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2018-02-01 0000-00-00 No No Current