FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58593-26558593-265-04DDiscontinued by firm2026-10-23

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
IngredientStrength
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310604Internal RxNorm lookup
1112205Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31ff48fc-9603-413c-ab7c-2598b3e08f9cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
58593-265-042023-08-03Drug Facts
58593-265-042023-08-03Drug Facts
58593-265-062023-08-03Drug Facts
58593-265-062023-08-03Drug Facts
58593-265-042023-07-28Drug Facts
58593-265-042023-07-28Drug Facts
58593-265-062023-07-28Drug Facts
58593-265-062023-07-28Drug Facts
58593-265-042020-02-16Drug Facts
58593-265-042020-02-16Drug Facts
58593-265-062020-02-16Drug Facts
58593-265-062020-02-16Drug Facts
58593-265-042020-01-31Drug Facts
58593-265-042020-01-31Drug Facts
58593-265-062020-01-31Drug Facts
58593-265-062020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-265-04Rompe PechoSF118 mL in 1 BOTTLELIQUID11815
58593-265-06Rompe PechoSF178 mL in 1 BOTTLELIQUID17815

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
GUAIFENESINACTIVE MOIETY495W7451VQROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
CAULOPHYLLUM THALICTROIDES ROOTINACTIVE INGREDIENTJTJ6HH6YEHROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DXROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
GINKGOINACTIVE INGREDIENT19FUJ2C58TROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JVROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
HOREHOUNDINACTIVE INGREDIENTK08036XEJVROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
MENTHOLINACTIVE INGREDIENTL7T10EIP3AROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
MYRRHINACTIVE INGREDIENTJC71GJ1F3LROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
PRUNUS SEROTINA BARKINACTIVE INGREDIENT5D48E975HAROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
ULMUS RUBRA BARKINACTIVE INGREDIENT91QY4PXU8QROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
VERBASCUM DENSIFLORUM LEAFINACTIVE INGREDIENT9936O846LIROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TBROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-265ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]14Current NDC, Legacy NDC, 2 package rows20241016_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 178 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and AllergyPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEAllegiant Health7af63769-fa56-4f1f-a2ad-5b4c108c8e4f2019-12-12WarningsExact identifier
application number: M012
Mucus Relief Immediate ReleaseGUAIFENESINAllegiant Health221d64a2-b8c7-435a-aae4-fb58fd38108f2019-03-26WarningsExact identifier
application number: M012
Sleep Tabs For Nighttime useDIPHENHYDRAMINE HCL TABLETSAllegiant Health566e40b1-e9d7-44e4-b971-eef2b7cf0a7d2018-12-26WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEAllegiant Health4305ad50-d2a5-4d3e-9d92-cbf26e856a162018-12-26WarningsExact identifier
application number: M012
Sleep AidDIPHENHYDRAMINE HCL 25 MGAllegiant Healthdbbc535f-515a-4d9b-b799-34e60f5230bb2018-12-21WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCLAllegiant Healthc2823bad-540f-4662-8dcc-58e9f0d94efb2018-11-07WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum Strength Non-DrowsyPHENYLEPHRINE 10 MGAllegiant Health7aef00df-816a-4ea2-a2ad-beed66dd2fe42018-11-07WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWestminster Pharmaceuticals, LLCa58bfb14-28f9-4425-a5a5-aaff4847c9792018-03-14WarningsExact identifier
application number: M012
Chlorpheniramine maleate 4mgCHLORPHENIRAMINE MALEATE 4MGAthlete's Needs, Inc.4d974959-25fc-4707-9b72-9afbf47b76f12017-11-14WarningsExact identifier
application number: M012
Cold MedicineACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLSelder, S.A. de C.V.d2762d9c-e7e7-42b2-a26a-14b2aa0307cb2017-01-25WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEMarc Glassman, Inc.2051247f-ce64-4cf5-b449-9ca14c43ab862016-12-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN31ff48fc-9603-413c-ab7c-2598b3e08f9c15
1112205Rompe Pecho 100 MG in 5 mL Oral SolutionPSN31ff48fc-9603-413c-ab7c-2598b3e08f9c15
1112205guaifenesin 20 MG/ML Oral Solution [Rompe Pecho]SBD31ff48fc-9603-413c-ab7c-2598b3e08f9c15
310604guaifenesin 20 MG/ML Oral SolutionSCD31ff48fc-9603-413c-ab7c-2598b3e08f9c15
310604guaifenesin 100 MG per 5 ML Oral SolutionSY31ff48fc-9603-413c-ab7c-2598b3e08f9c15
310604guaifenesin 100 MG per 5 ML Oral SyrupSY31ff48fc-9603-413c-ab7c-2598b3e08f9c15
310604guaifenesin 200 MG per 10 ML Oral SolutionSY31ff48fc-9603-413c-ab7c-2598b3e08f9c15
310604guaifenesin 300 MG per 15 ML Oral SolutionSY31ff48fc-9603-413c-ab7c-2598b3e08f9c15
310604guaifenesin 400 MG per 20 ML Oral SolutionSY31ff48fc-9603-413c-ab7c-2598b3e08f9c15
1112205Rompe Pecho 100 MG per 5 ML Oral SolutionSY31ff48fc-9603-413c-ab7c-2598b3e08f9c15
1112205Rompe Pecho 20 MG/ML Oral SolutionSY31ff48fc-9603-413c-ab7c-2598b3e08f9c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58593-265-0458593026504118 mL in 1 BOTTLE (58593-265-04) 118 ml2015-01-010000-00-00NoNoCurrent
58593-265-0658593026506178 mL in 1 BOTTLE (58593-265-06) 178 ml1999-03-010000-00-00NoNoCurrent