Home NDC 58593-265 Rompe Pecho
Product NDC 58593-265
11-digit product format 585930265
Labeler code 58593
Product ID 58593-265_411e96f1-d9a3-1820-e063-6294a90a8a69
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 1999-03-01
Substance GUAIFENESIN
Active strength 100 mg/5mL
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 SF
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL
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 58593-265-04 Rompe PechoSF 118 mL in 1 BOTTLE LIQUID 118 15 58593-265-06 Rompe PechoSF 178 mL in 1 BOTTLE LIQUID 178 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 CAULOPHYLLUM THALICTROIDES ROOT INACTIVE INGREDIENT JTJ6HH6YEH ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 ECHINACEA, UNSPECIFIED INACTIVE INGREDIENT 4N9P6CC1DX ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 EUCALYPTUS OIL INACTIVE INGREDIENT 2R04ONI662 ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 GINKGO INACTIVE INGREDIENT 19FUJ2C58T ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 GLYCYRRHIZA GLABRA INACTIVE INGREDIENT 2788Z9758H ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 GOLDENSEAL INACTIVE INGREDIENT ZW3Z11D0JV ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 HOREHOUND INACTIVE INGREDIENT K08036XEJV ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 MENTHOL INACTIVE INGREDIENT L7T10EIP3A ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 MYRRH INACTIVE INGREDIENT JC71GJ1F3L ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 POTASSIUM CITRATE INACTIVE INGREDIENT EE90ONI6FF ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 PRUNUS SEROTINA BARK INACTIVE INGREDIENT 5D48E975HA ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 ULMUS RUBRA BARK INACTIVE INGREDIENT 91QY4PXU8Q ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 VERBASCUM DENSIFLORUM LEAF INACTIVE INGREDIENT 9936O846LI ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4 ZINC SULFATE INACTIVE INGREDIENT 89DS0H96TB ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58593-265 ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.] 14 Current NDC, Legacy NDC, 2 package rows 20241016_31ff48fc-9603-413c-ab7c-2598b3e08f9c.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 132 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 82813342-2be2-4731-ae90-dbd5eed667a9 2024-12-10 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. b640a5d2-a7fe-486d-a65f-e7c993f950d6 2024-12-10 Warnings Exact identifier application number: M012 Sugar Free Mountain Herb Cough Suppressant Throat Drops MENTHOL Ricola USA Inc. c3f3c062-55e5-43c1-a016-ee47a7b388a5 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola USA Inc. ee4733b5-6e5a-438a-97da-110f3ef6c809 2024-12-10 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola USA Inc. f62fcc38-2d43-40b3-841f-c8eea9ebd1e1 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 8a6db093-7e52-443f-8dd6-94867606fef8 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola USA Inc. 5885343e-4a6e-44f7-87a4-d52599156197 2024-12-10 Warnings Exact identifier application number: M012 EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola USA Inc. 0baf383c-886d-47ca-8a6d-221298c79446 2024-12-10 Warnings Exact identifier application number: M012 Tussin Multi Symptom Cold CF DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE Best Choice (Valu Merchandisers Company) 539b8972-2a46-468e-ad27-6672d746feb7 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. db2ab9be-507d-4768-9d00-188f751b7726 2024-12-10 Warnings Exact identifier application number: M012 Adult Allergy Relief CALMCO ALLERGY RELIEF CalmCo 08288825-0f38-b6a3-e063-6394a90aa358 2024-12-07 Warnings Exact identifier application number: M012 Original Herb Cough Drops MENTHOL Ricola Ag c142663f-086e-4ab7-a758-9107d7077537 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 984c9793-163c-4b97-b244-9b471966a122 2024-12-05 Warnings Exact identifier application number: M012 BENZEDREX PROPYLHEXEDRINE BF ASCHER AND CO INC 00d8c237-3eee-1d9f-e063-6394a90aeb86 2024-12-05 Warnings Exact identifier application number: M012 Cold Multi Symptom Daytime Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE Chain Drug Marketing Association d5cbb5b0-564c-429e-b680-fa683e796393 2024-12-05 Warnings Exact identifier application number: M012 Cold Relief Multi-Symptom ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCare de8a623f-7b10-4d56-a74b-3737e7716ffe 2024-12-05 Warnings Exact identifier application number: M012 Cold Max Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 9773958b-c5e5-4da7-a8e9-6b6c223a2b30 2024-12-05 Warnings Exact identifier application number: M012 Cold Plus Head Congestion Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 399e0e51-c2a7-451c-b74d-d3db140cef69 2024-12-05 Warnings Exact identifier application number: M012 Head Congestion Plus Mucus PE ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE United Natural Foods, Inc. dba UNFI 09531edc-8dbd-451f-ae02-f922e9e8c248 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 71ca8af7-172d-40da-be1e-ff3ab5568e74 2024-12-05 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 58593-265-04 58593026504 118 mL in 1 BOTTLE (58593-265-04) 118 ml 2015-01-01 0000-00-00 No No Current 58593-265-06 58593026506 178 mL in 1 BOTTLE (58593-265-06) 178 ml 1999-03-01 0000-00-00 No No Current