FDA.reportPublic FDA data

Rompe Pecho

Product NDC
58593-275
11-digit product format
585930275
Labeler code
58593
Product ID
58593-275_411e98a6-621c-3e32-e063-6394a90aa647
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Efficient Laboratories Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-10-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 100 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rompe Pecho
Brand name suffix
DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui996520

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58593-275-042023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102023-08-03C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102023-07-28C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102020-02-16C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-042020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-062020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-082020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho
58593-275-102020-01-31C16284748780-19d75b9d0-3277-f424-e053-dadaa90a57ceRompe Pecho

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-275-04Rompe PechoDM118 mL in 1 BOTTLELIQUID11817
58593-275-06Rompe PechoDM178 mL in 1 BOTTLELIQUID17817
58593-275-08Rompe PechoDM237 mL in 1 BOTTLELIQUID23717
58593-275-10Rompe PechoDM10 mL in 1 POUCHLIQUID1017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
GUAIFENESINACTIVE INGREDIENT495W7451VQROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
GUAIFENESINACTIVE MOIETY495W7451VQROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
ASCLEPIAS TUBEROSA ROOTINACTIVE INGREDIENT1ZL82U5D18ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
CAULOPHYLLUM THALICTROIDES ROOTINACTIVE INGREDIENTJTJ6HH6YEHROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DXROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
GINKGOINACTIVE INGREDIENT19FUJ2C58TROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JVROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
HONEYINACTIVE INGREDIENTY9H1V576FHROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3AROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
MYRRHINACTIVE INGREDIENTJC71GJ1F3LROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOFROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
PRUNUS SEROTINA BARKINACTIVE INGREDIENT5D48E975HAROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
SPEARMINTINACTIVE INGREDIENTJ7I2T6IV1NROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
ULMUS RUBRA BARKINACTIVE INGREDIENT91QY4PXU8QROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
VERBASCUM DENSIFLORUM LEAFINACTIVE INGREDIENT9936O846LIROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
WATERINACTIVE INGREDIENT059QF0KO0RROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TBROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-275ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]16Current NDC, Legacy NDC, 4 package rows20241012_d108c712-bc36-41d7-9ccd-720496b5599e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNd108c712-bc36-41d7-9ccd-720496b5599e17
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDd108c712-bc36-41d7-9ccd-720496b5599e17
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYd108c712-bc36-41d7-9ccd-720496b5599e17
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYd108c712-bc36-41d7-9ccd-720496b5599e17
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYd108c712-bc36-41d7-9ccd-720496b5599e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58593-275-0458593027504118 mL in 1 BOTTLE (58593-275-04) 118 ml2015-01-010000-00-00NoNoCurrent
58593-275-0658593027506178 mL in 1 BOTTLE (58593-275-06) 178 ml2001-10-010000-00-00NoNoCurrent
58593-275-0858593027508237 mL in 1 BOTTLE (58593-275-08) 237 ml2015-01-010000-00-00NoNoCurrent
58593-275-105859302751010 mL in 1 POUCH (58593-275-10) 10 ml2001-10-010000-00-00NoNoCurrent