Home NDC 58552-337 PHENAGIL
Product NDC 58552-337
11-digit product format 585520337
Labeler code 58552
Product ID 58552-337_5a7f4849-c918-39bb-e063-6294a90a2f9e
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCL
Dosage form TABLET
Route ORAL
Labeler Gil Pharmaceutical Corp.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-26
Marketing end 2027-06-30
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 3.5; 29; 10 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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 CHLORPHENIRAMINE MALEATE 3.5 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 29 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1Q0O9OJ9Z Internal UNII lookup 9D2RTI9KYH 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 2603661 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 58552-337-01 PHENAGIL 100 in 1 BOTTLE TABLET 100 5 58552-337-02 PHENAGIL 2 in 1 BLISTER PACK TABLET 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58552-337 PHENAGIL (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP.] 4 Current NDC, Legacy NDC, 2 package rows 20241027_a6880389-0dc1-43a7-a73b-77f77bafe51e.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 98 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 58552-337-01 58552033701 100 TABLET in 1 BOTTLE (58552-337-01) 100 tablet 2022-05-26 2027-06-30 No No Current 58552-337-02 58552033702 2 TABLET in 1 BLISTER PACK (58552-337-02) 2 tablet 2022-05-26 2027-06-30 No No Current