FDA.reportPublic FDA data

Rompe Pecho

Product NDC
58593-829
11-digit product format
585930829
Labeler code
58593
Product ID
58593-829_26e4f72a-b911-8dc6-e063-6394a90a4326
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
2015-01-01
Substance
GUAIFENESIN
Active strength
200 mg/10mL
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

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
EX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/10mL

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
89ea23a5-0da7-407e-83d9-77a0b562f3afAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
58593-829-042023-08-03Drug Facts
58593-829-062023-08-03Drug Facts
58593-829-042023-07-28Drug Facts
58593-829-062023-07-28Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-829-04Rompe PechoEX118 mL in 1 BOTTLELIQUID11812
58593-829-06Rompe PechoEX178 mL in 1 BOTTLELIQUID17812

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
GUAIFENESINACTIVE MOIETY495W7451VQROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
ASCLEPIAS TUBEROSA ROOTINACTIVE INGREDIENT1ZL82U5D18ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
CAULOPHYLLUM THALICTROIDES ROOTINACTIVE INGREDIENTJTJ6HH6YEHROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DXROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
GINKGOINACTIVE INGREDIENT19FUJ2C58TROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JVROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
HONEYINACTIVE INGREDIENTY9H1V576FHROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
HOREHOUNDINACTIVE INGREDIENTK08036XEJVROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
MYRRHINACTIVE INGREDIENTJC71GJ1F3LROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
PRUNUS SEROTINA BARKINACTIVE INGREDIENT5D48E975HAROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
ULMUS RUBRA BARKINACTIVE INGREDIENT91QY4PXU8QROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
VERBASCUM DENSIFLORUM LEAFINACTIVE INGREDIENT9936O846LIROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
WATERINACTIVE INGREDIENT059QF0KO0RROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TBROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-829ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]12Current NDC, Legacy NDC, 2 package rows20241116_89ea23a5-0da7-407e-83d9-77a0b562f3af.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 108 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals1b591e27-b00b-41c8-9fe9-c633aba091342025-08-01WarningsExact identifier
application number: M012
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.377248b6-d64d-8dff-e063-6394a90a43f62025-07-31WarningsExact identifier
application number: M012
meijer Daytime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.3771f778-7ac9-7108-e063-6394a90a11052025-07-31WarningsExact identifier
application number: M012
tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINCVS Pharmacy087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca2025-07-31WarningsExact identifier
application number: M012
Equate NasalOXYMETAZOLINE HCLWal-Mart Stores Incc38a2783-aed9-466d-8976-59d03a792c042025-07-30WarningsExact identifier
application number: M012
Quality Choice Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3b15d2ea-f784-275d-e063-6394a90a800c2025-07-29WarningsExact identifier
application number: M012
Respiratory ReliefGUAIFENESINSchwabe North America, Incf683041a-4ff9-42a5-9047-a9a3140a87582025-07-29WarningsExact identifier
application number: M012
Childrens Robitussin Honey Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCb87f700e-3414-463c-80d4-c3dbca89a4882025-07-29WarningsExact identifier
application number: M012
Tussin DMTUSSIN DMAllegiant Health7a2f8d48-3123-4c37-b238-bd7cc4242bb72025-07-23WarningsExact identifier
application number: M012
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Inc5fb2438b-8f2d-4af2-9981-42d278d268002025-07-23WarningsExact identifier
application number: M012
DR. SANA COUGH AND CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Incbaca0580-4c30-4b94-89fa-a7cf06d4ff252025-07-22WarningsExact identifier
application number: M012
Defensol DACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCIMenper Distributors, Inc.f466c660-69eb-4581-81ff-1499fa421d8b2025-07-22WarningsExact identifier
application number: M012
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
application number: M012
BroncofinDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMenper Distributors, Inc.fdf67382-1692-485b-92f1-2cbb8be4fb702025-07-22WarningsExact identifier
application number: M012
Defensol Adult SyrupGUAIFENESIN, DEXTROMETHORPHAN HBRMenper Distributors, Inc.62acff69-8c40-4a0e-8d56-be2cc14e3d452025-07-22WarningsExact identifier
application number: M012
Cosedal DropsDEXTROMETHORPHAN HBR, GUAIFENESINMenper Distributors, Inc.1241d249-ea3b-4d2b-87ed-835d6a2d286a2025-07-22WarningsExact identifier
application number: M012
Berro y Cebolla DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMenper Distributors, Inc.20107bd9-6d84-4ab5-a0d9-966f1f11d9192025-07-22WarningsExact identifier
application number: M012
Defensol-itoDEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINEMenper Distributors, Inca7c7a60d-d49f-4239-92f7-714eac7eb0c52025-07-22WarningsExact identifier
application number: M012
Bisolvine ChildrenGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.896a5443-e3d2-4af7-9e27-f1c1899ce0382025-07-22WarningsExact identifier
application number: M012
Bisolvine Aloe-MielDEXTROMETHORPHAN, GUAIFENESINMENPER DISTRIBUTORS INC.34801c79-ce88-492f-808e-b639e86016072025-07-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN89ea23a5-0da7-407e-83d9-77a0b562f3af12
1112205Rompe Pecho 100 MG in 5 mL Oral SolutionPSN89ea23a5-0da7-407e-83d9-77a0b562f3af12
1112205guaifenesin 20 MG/ML Oral Solution [Rompe Pecho]SBD89ea23a5-0da7-407e-83d9-77a0b562f3af12
310604guaifenesin 20 MG/ML Oral SolutionSCD89ea23a5-0da7-407e-83d9-77a0b562f3af12
310604guaifenesin 100 MG per 5 ML Oral SolutionSY89ea23a5-0da7-407e-83d9-77a0b562f3af12
310604guaifenesin 100 MG per 5 ML Oral SyrupSY89ea23a5-0da7-407e-83d9-77a0b562f3af12
310604guaifenesin 200 MG per 10 ML Oral SolutionSY89ea23a5-0da7-407e-83d9-77a0b562f3af12
310604guaifenesin 300 MG per 15 ML Oral SolutionSY89ea23a5-0da7-407e-83d9-77a0b562f3af12
310604guaifenesin 400 MG per 20 ML Oral SolutionSY89ea23a5-0da7-407e-83d9-77a0b562f3af12
1112205Rompe Pecho 100 MG per 5 ML Oral SolutionSY89ea23a5-0da7-407e-83d9-77a0b562f3af12
1112205Rompe Pecho 20 MG/ML Oral SolutionSY89ea23a5-0da7-407e-83d9-77a0b562f3af12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58593-829-0458593082904118 mL in 1 BOTTLE (58593-829-04) 118 ml2019-04-010000-00-00NoNoCurrent
58593-829-0658593082906178 mL in 1 BOTTLE (58593-829-06) 178 ml2015-01-010000-00-00NoNoCurrent