Home NDC 58552-336 Gilphex
Product NDC 58552-336
11-digit product format 585520336
Labeler code 58552
Product ID 58552-336_40b9f8d7-5f71-656f-e063-6294a90a3b8b
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin, Phenylephrine HCl
Dosage form TABLET
Route ORAL
Labeler Gil Pharmaceutical Corp.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-05
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 390; 10 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 Gilphex
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 390 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 2603663 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58552-336-01 Gilphex 100 in 1 BOTTLE TABLET 100 5 58552-336-02 Gilphex 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 58552-336 GILPHEX (GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP.] 4 Current NDC, Legacy NDC, 2 package rows 20241027_e7c8fb97-02cf-4df6-b477-9ff69d6b675d.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 58552-336-01 58552033601 100 TABLET in 1 BOTTLE (58552-336-01) 100 tablet 2022-05-05 0000-00-00 No No Current 58552-336-02 58552033602 2 TABLET in 1 BLISTER PACK (58552-336-02) 2 tablet 2022-05-05 0000-00-00 Yes No Current