FDA.reportPublic FDA data

Rompe Pecho

Product NDC
58593-225
Requested package NDC
58593-225-06
11-digit product format
585930225
Labeler code
58593
Product ID
58593-225_d242f252-1b0a-dbc0-e053-2995a90a7ee9
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan, Brompheniramine Maleate, Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Efficient Laboratories Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-10-01
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage58593-22558593-225-06DDiscontinued by firm2026-11-03

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-08-03Drug Facts
2023-07-28Drug Facts
2020-02-18Drug Facts
2020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-225-06Rompe PechoSF FLU178 mL in 1 BOTTLELIQUID17817

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03ROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
CAULOPHYLLUM THALICTROIDES ROOTINACTIVE INGREDIENTJTJ6HH6YEHROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DXROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6ROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
GINKGOINACTIVE INGREDIENT19FUJ2C58TROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JVROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
HONEYINACTIVE INGREDIENTY9H1V576FHROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
HOREHOUNDINACTIVE INGREDIENTK08036XEJVROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
MENTHOLINACTIVE INGREDIENTL7T10EIP3AROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
MYRRHINACTIVE INGREDIENTJC71GJ1F3LROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
POLYGLYCERIN-10INACTIVE INGREDIENTP9060O936AROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
PRUNUS SEROTINA BARKINACTIVE INGREDIENT5D48E975HAROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
ULMUS RUBRA BARKINACTIVE INGREDIENT91QY4PXU8QROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
VERBASCUM DENSIFLORUM LEAFINACTIVE INGREDIENT9936O846LIROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
WATERINACTIVE INGREDIENT059QF0KO0RROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TBROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-225ROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC]17Legacy NDC, 1 package rows20250328_bc10695a-9664-4ce3-82bb-820da06129fa.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rompe Pecho SF FLUDEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEEfficient Laboratories Incbc10695a-9664-4ce3-82bb-820da06129fa2025-03-26WarningsExact identifier
ndc (package): 58593-225-06
ndc (product): 58593-225
ndc11 (package): 58593022506

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58593-225-0658593022506178 mL in 1 BOTTLE (58593-225-06) 178 ml2007-10-010000-00-00NoNoCurrent