Home NDC 58593-829 Rompe Pecho
Product NDC 58593-829
11-digit product format 585930829
Labeler code 58593
Product ID 58593-829_26e4f72a-b911-8dc6-e063-6394a90a4326
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Efficient Laboratories Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-01-01
Substance GUAIFENESIN
Active strength 200 mg/10mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Rompe Pecho
Brand name suffix EX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 200 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310604 Internal RxNorm lookup 1112205 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58593-829-04 Rompe PechoEX 118 mL in 1 BOTTLE LIQUID 118 12 58593-829-06 Rompe PechoEX 178 mL in 1 BOTTLE LIQUID 178 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58593-829 ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 12 Current NDC, Legacy NDC, 2 package rows 20241116_89ea23a5-0da7-407e-83d9-77a0b562f3af.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 58593-829-04 58593082904 118 mL in 1 BOTTLE (58593-829-04) 118 ml 2019-04-01 0000-00-00 No No Current 58593-829-06 58593082906 178 mL in 1 BOTTLE (58593-829-06) 178 ml 2015-01-01 0000-00-00 No No Current