Home NDC 73057-389 Pharbinex-PE
Product NDC 73057-389
11-digit product format 730570389
Labeler code 73057
Product ID 73057-389_2c2a2804-8a2b-be5d-e063-6394a90a9763
Type HUMAN OTC DRUG
Nonproprietary name GUAIFENESIN 400mg and PHENYLEPHRINE HCL 10MG
Dosage form TABLET, COATED
Route ORAL
Labeler Ulai Health LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-18
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 400; 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 73057-389-04 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 73057-389-04 0efc9e666f02…f202fb6c5f17…
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 Pharbinex-PE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 400 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 1304111 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73057-389-04 Pharbinex-PE 30 in 1 BOTTLE, PLASTIC TABLET, COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73057-389 PHARBINEX-PE (GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG) TABLET, COATED [ULAI HEALTH LLC] 3 Current NDC, Legacy NDC, 1 package rows 20250122_e459bb83-b1d6-42fc-aa46-99ad117e6144.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 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 73057-389-04 73057038904 30 TABLET, COATED in 1 BOTTLE, PLASTIC (73057-389-04) 2019-07-18 0000-00-00 No No Current