Home NDC 58593-235 Rompe Pecho
Product NDC 58593-235
11-digit product format 585930235
Labeler code 58593
Product ID 58593-235_3e6375e6-6668-3453-e063-6394a90add02
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL
Dosage form LIQUID
Route ORAL
Labeler Efficient Laboratories Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2007-10-01
Marketing end 2027-03-31
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 10; 100; 5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 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 · 35 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 CF Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL GUAIFENESIN 100 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 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 1044949 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 58593-235-04 Rompe PechoCF 118 mL in 1 BOTTLE LIQUID 118 26 58593-235-06 Rompe PechoCF 178 mL in 1 BOTTLE LIQUID 178 26 58593-235-08 Rompe PechoCF 237 mL in 1 BOTTLE LIQUID 237 26 58593-235-10 Rompe PechoCF 10 mL in 1 POUCH LIQUID 10 26 58593-235-29 Rompe PechoCF 296 mL in 1 BOTTLE LIQUID 296 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 CAULOPHYLLUM THALICTROIDES ROOT INACTIVE INGREDIENT JTJ6HH6YEH ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 ECHINACEA, UNSPECIFIED INACTIVE INGREDIENT 4N9P6CC1DX ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 EUCALYPTUS GLOBULUS LEAF INACTIVE INGREDIENT S546YLW6E6 ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 GINKGO INACTIVE INGREDIENT 19FUJ2C58T ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 GLYCYRRHIZA GLABRA INACTIVE INGREDIENT 2788Z9758H ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 GOLDENSEAL INACTIVE INGREDIENT ZW3Z11D0JV ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 HONEY INACTIVE INGREDIENT Y9H1V576FH ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 HOREHOUND INACTIVE INGREDIENT K08036XEJV ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 MENTHOL INACTIVE INGREDIENT L7T10EIP3A ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 MYRRH INACTIVE INGREDIENT JC71GJ1F3L ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 PRUNUS SEROTINA BARK INACTIVE INGREDIENT 5D48E975HA ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 ULMUS RUBRA BARK INACTIVE INGREDIENT 91QY4PXU8Q ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 VERBASCUM DENSIFLORUM LEAF INACTIVE INGREDIENT 9936O846LI ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 WATER INACTIVE INGREDIENT 059QF0KO0R ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5 ZINC SULFATE INACTIVE INGREDIENT 89DS0H96TB ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58593-235 ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] 25 Current NDC, Legacy NDC, 5 package rows 20250328_96c4dee1-6e66-4442-a7e3-56e874414c17.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 58593-235-04 58593023504 118 mL in 1 BOTTLE (58593-235-04) 118 ml 2015-01-01 0000-00-00 No No Current 58593-235-06 58593023506 178 mL in 1 BOTTLE (58593-235-06) 178 ml 2007-10-01 0000-00-00 No No Current 58593-235-08 58593023508 237 mL in 1 BOTTLE (58593-235-08) 237 ml 2015-01-01 0000-00-00 No No Current 58593-235-10 58593023510 10 mL in 1 POUCH (58593-235-10) 10 ml 2019-01-01 2027-03-31 No No Current 58593-235-29 58593023529 296 mL in 1 BOTTLE (58593-235-29) 296 ml 2015-01-01 0000-00-00 No No Current