Home NDC 58552-322 PHENAGIL
Product NDC 58552-322
11-digit product format 585520322
Labeler code 58552
Product ID 58552-322_5a7f4613-27b7-02d4-e063-6394a90a07d6
Type HUMAN OTC DRUG
Nonproprietary name PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE
Dosage form TABLET
Route ORAL
Labeler Gil Pharmaceutical Corp
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-12-14
Marketing end 2027-06-30
Substance PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active strength 10; 3.5 mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 PHENAGIL Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 CHLORPHENIRAMINE MALEATE 3.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup V1Q0O9OJ9Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1367227 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 58552-322-01 PHENAGIL 100 in 1 BOTTLE TABLET 100 8 58552-322-02 PHENAGIL 2 in 1 POUCH TABLET 2 8 58552-322-02 PHENAGIL 12 in 1 BOX TABLET 12 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58552-322 PHENAGIL (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [GIL PHARMACEUTICAL CORP] 7 Current NDC, Legacy NDC, 3 package rows 20241027_69fd13a1-2b76-8574-e053-2a91aa0a27e7.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 · 3,551 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 58552-322-01 58552032201 100 TABLET in 1 BOTTLE (58552-322-01) 100 tablet 2012-12-14 2027-06-30 No No Current 58552-322-02 58552032202 12 POUCH in 1 BOX (58552-322-02) / 2 TABLET in 1 POUCH 12 pouch 2012-12-14 2027-06-30 No No Current