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 71 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Honey Lemon cough drops MENTHOL Walmart Stores Inc. 317bbd33-6087-3af1-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Good Sense Nasal Decongestant PSEUDOEPHEDRINE HCL L. Perrigo Company 455b35b4-3969-411b-8036-887615d71e11 2025-12-21 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Safeway Inc. 4a4f7f82-1b6c-7082-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 Cherry Cough Drop MENTHOL Safeway Inc. 4a52c0c2-8659-2819-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Cherry Cough Drops MENTHOL Safeway a733e905-af15-d3ea-e053-2a95a90aa7c3 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Honey Lemon Cough Drops MENTHOL Safeway a742449f-c76b-2b91-e053-2a95a90ae4d2 2025-12-20 Warnings Exact identifier application number: M012 Cherry Sore Throat Lozenge BENZOCAINE TopCo 60b876e7-c642-5ce8-e053-2a91aa0abd6e 2025-12-20 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Topco Associates 366cc6b1-beff-29d2-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL TopCo Associates 3fef2117-7311-1e66-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Topco Associates 3ff1bf05-e407-3b67-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free menthol cough drops MENTHOL Topco Associates 36727f0c-d6d2-28a3-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL Topco Associates 36824bee-607e-7095-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Mixed Berry Sore Throat Lozenges BENZOCAINE Topco Associates 7a00c771-9231-e877-e053-2a91aa0ac96e 2025-12-20 Warnings Exact identifier application number: M012 MUCUS RELIEF GUAIFENESIN 400 MG NUVICARE LLC e25b440e-f389-443f-b333-c66ad1747158 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu severe ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL Wal-Mart Stores Inc 9fca25dc-f63e-487a-8b7c-84d65ea51cb5 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Geiss, Destin & Dunn Inc. a7d2eaee-484e-43aa-8ae3-0e050219383f 2025-12-19 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Publix 66d8e5f7-9766-57f3-e053-2991aa0a7e17 2025-12-19 Warnings Exact identifier application number: M012 Honey Lemon Cough Drops MENTHOL Publix 66e89fa3-ee09-1d16-e053-2a91aa0ae17c 2025-12-19 Warnings Exact identifier application number: M012 Poly-Vent DM DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL Poly Pharmaceuticals, Inc. 739329ae-0b62-4eab-a07d-867b5d3d61e0 2025-12-19 Warnings Exact identifier application number: M012 Chest Congestion and Cough Relief DM DEXTROMETHORPHAN HBR, GUAIFENESIN ARMY AND AIR FORCE EXCHANGE SERVICE 89494a7c-cdbf-48f1-aaa9-2e57d4388a68 2025-12-19 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