Home NDC 58593-275 Rompe Pecho
Product NDC 58593-275
11-digit product format 585930275
Labeler code 58593
Product ID 58593-275_411e98a6-621c-3e32-e063-6394a90aa647
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Efficient Laboratories Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2001-10-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10; 100 mg/5mL; mg/5mL
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 36 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 DM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL GUAIFENESIN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996520 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 58593-275-04 Rompe PechoDM 118 mL in 1 BOTTLE LIQUID 118 17 58593-275-06 Rompe PechoDM 178 mL in 1 BOTTLE LIQUID 178 17 58593-275-08 Rompe PechoDM 237 mL in 1 BOTTLE LIQUID 237 17 58593-275-10 Rompe PechoDM 10 mL in 1 POUCH LIQUID 10 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 ASCLEPIAS TUBEROSA ROOT INACTIVE INGREDIENT 1ZL82U5D18 ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 CAULOPHYLLUM THALICTROIDES ROOT INACTIVE INGREDIENT JTJ6HH6YEH ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 ECHINACEA, UNSPECIFIED INACTIVE INGREDIENT 4N9P6CC1DX ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 EUCALYPTUS GLOBULUS LEAF INACTIVE INGREDIENT S546YLW6E6 ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 GINKGO INACTIVE INGREDIENT 19FUJ2C58T ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 GLYCYRRHIZA GLABRA INACTIVE INGREDIENT 2788Z9758H ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 GOLDENSEAL INACTIVE INGREDIENT ZW3Z11D0JV ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 HONEY INACTIVE INGREDIENT Y9H1V576FH ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 MENTHOL INACTIVE INGREDIENT L7T10EIP3A ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 MYRRH INACTIVE INGREDIENT JC71GJ1F3L ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 PROPOLIS WAX INACTIVE INGREDIENT 6Y8XYV2NOF ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 PRUNUS SEROTINA BARK INACTIVE INGREDIENT 5D48E975HA ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 SPEARMINT INACTIVE INGREDIENT J7I2T6IV1N ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 ULMUS RUBRA BARK INACTIVE INGREDIENT 91QY4PXU8Q ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 VERBASCUM DENSIFLORUM LEAF INACTIVE INGREDIENT 9936O846LI ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 WATER INACTIVE INGREDIENT 059QF0KO0R ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5 ZINC SULFATE INACTIVE INGREDIENT 89DS0H96TB ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58593-275 ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC] 16 Current NDC, Legacy NDC, 4 package rows 20241012_d108c712-bc36-41d7-9ccd-720496b5599e.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 68 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate SF Menthol Cough Drops MENTHOL WalMart 003a229c-b014-e9f3-e063-6294a90aa5ed 2025-12-23 Warnings Exact identifier application number: M012 Equate Menthol Cough Drops MENTHOL Walmart 124e6968-f59c-39d4-e063-6294a90a66d4 2025-12-23 Warnings Exact identifier application number: M012 Equate Severe Menthol Throat Drop MENTHOL Walmart 125f3f5a-52aa-e398-e063-6394a90a0012 2025-12-23 Warnings Exact identifier application number: M012 Equate Menthol Chewable Gels MENTHOL Walmart 1ba4b2be-7242-0a23-e063-6294a90af29c 2025-12-23 Warnings Exact identifier application number: M012 Walgreens Severe Menthol Throat Drops MENTHOL Walgreens 21dd3c68-cbc6-4799-e063-6394a90a6972 2025-12-23 Warnings Exact identifier application number: M012 cherry throat relief lozenges BENZOCAINE Zee Medical 499d0748-538f-678c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 Guaiasorb DM DEXTROMETHORPHAN HBR, GUAIFENESIN NuCare Pharmaceuticals, Inc. 46a480c7-7092-b809-e063-6294a90a60cd 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 360a6304-206d-5475-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 36342d8c-34ab-6178-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Winco Foods 37244333-1307-5121-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco foods 37718c73-880e-4a5c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco Foods 40676ddc-577f-5cc9-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 Sugar Free Menthol Cough Drops MENTHOL Winco Foods 3788e8b6-ab9e-1513-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 SAFETUSSIN Non Drowsy Cough plus chest congestion DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN KRAMER LABORATORIES eeca6370-29ea-4540-8139-e8461d58a286 2025-12-23 Warnings Exact identifier application number: M012 Tussin DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Discount Drug Mart dd31f86b-f59e-459a-8e5f-176828706a4a 2025-12-23 Warnings Exact identifier application number: M012 Tussin CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Discount Drug Mart f8e7a08e-7422-4a1b-bfec-93e0b50d10cd 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ae97-7951-4058-e053-2995a90a7b2e 2025-12-23 Warnings Exact identifier application number: M012 Childrens Chest Congestion Relief Grape GUAIFENESIN Discount Drug Mart 3e5d245f-515c-4106-a855-fb97681b646a 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ed16-86bb-3faf-e053-2995a90acfbc 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC a7999da7-148a-4c6d-a2ea-0f4cc1d5b283 2025-12-23 Warnings Exact identifier application number: M012
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 58593-275-04 58593027504 118 mL in 1 BOTTLE (58593-275-04) 118 ml 2015-01-01 0000-00-00 No No Current 58593-275-06 58593027506 178 mL in 1 BOTTLE (58593-275-06) 178 ml 2001-10-01 0000-00-00 No No Current 58593-275-08 58593027508 237 mL in 1 BOTTLE (58593-275-08) 237 ml 2015-01-01 0000-00-00 No No Current 58593-275-10 58593027510 10 mL in 1 POUCH (58593-275-10) 10 ml 2001-10-01 0000-00-00 No No Current