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 175 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sinus Pressure plus Pain PE ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE RETAIL BUSINESS SERVICES , LLC. eb64750f-19ac-655f-e053-2995a90a33b5 2023-11-02 Warnings Exact identifier application number: M012 Multi-Symptom Mapap Cold Formula ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL Proficient Rx LP 9bf81b26-38b4-486c-ae89-222119ce1a4f 2023-11-01 Warnings Exact identifier application number: M012 Guaifenesin Syrup and Dextromethorphan GUAIFENESIN SYRUP AND DEXTROMETHORPHAN Natco Pharma USA LLC ad9026f4-f0b6-4d02-aa44-f0460eeefc0e 2023-11-01 Warnings Exact identifier application number: M012 Diphenhydramine HCl Oral Solution DIPHENHYDRAMINE HYDROCHLORIDE Natco Pharma USA LLC 54b64354-ac10-42ff-a53d-96cef933a91a 2023-11-01 Warnings Exact identifier application number: M012 children allergy relief dye free cherry DIPHENHYDRAMINE HCL A-S Medication Solutions 5c6c1809-4c6f-4e8f-a5ae-9796e821d400 2023-11-01 Warnings Exact identifier application number: M012 Daytime and Nighttime Cherry Cold and Flu DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE TARGET CORPORATION 0903b222-1a44-64aa-e063-6294a90abba0 2023-10-31 Warnings Exact identifier application number: M012 Ephrine Nose Drops PHENYLEPHRINE HYDROCHLORIDE Walgreens b620eb9f-2caf-0942-e053-2a95a90ae48e 2023-10-31 Warnings Exact identifier application number: M012 pseudoephedrine hydrochloride PSEUDOEPHEDRINE HCL A-S Medication Solutions 204849d1-ac4b-4dbe-8769-fcb30291f880 2023-10-31 Warnings Exact identifier application number: M012 Daytime Cold and Flu Relief DAYTIME COLD AND FLU RELIEF TopCo Associates, LLC d592fbb8-d4bf-444e-982e-edf6fe97dce4 2023-10-31 Warnings Exact identifier application number: M012 Nite Time Cold and Flu Relief NITE TIME COLD AND FLU RELIEF TopCo Associates, LLC 407dc4ae-882d-4a49-8884-ef048bb404cf 2023-10-31 Warnings Exact identifier application number: M012 12 Hour Original Nasal Decongestant NASAL SPRAY Sheffield Pharmaceuticals LLC cea0ce76-ae75-4484-a7c2-ff1086e9d8b0 2023-10-30 Warnings Exact identifier application number: M012 Mucosa DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Magno-Humphries, Inc. 3a5533fb-1c83-4b95-9cd2-9be663d3ff5f 2023-10-27 Warnings Exact identifier application number: M012 Mucosa Guifenesin GUAIFENESIN Magno-Humphries, Inc. 9d22c208-d0ae-8b6a-e053-2995a90ab90a 2023-10-27 Warnings Exact identifier application number: M012 DG Health Cough Drops Cherry Flavor MENTHOL Dollar General Corporation c7a603d8-72fb-9626-e053-2995a90a09ea 2023-10-26 Warnings Exact identifier application number: M012 Allergy Relief 4 Hour CHLORPHENIRAMINE MALEATE Geri-Care Pharmaceutical Corp 92d90b41-0627-121e-e053-2995a90a2df1 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry MENTHOL Riclan S.A. 8e471265-3594-451a-8921-f0db474abe85 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Eucalyptus MENTHOL Riclan S.A. 1141593a-f3ba-4adf-b332-f9fcb0b5a013 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon MENTHOL Riclan S.A. f6271e85-9ca2-41d3-9bff-a13670ac5b80 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Strawberry MENTHOL Riclan S.A. da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457 2023-10-26 Warnings Exact identifier application number: M012 DG Health Cough Drops Assorted Flavors MENTHOL Dollar General Corporation c731d255-40f2-3cb3-e053-2a95a90a8877 2023-10-26 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