FDA.reportPublic FDA data

Rompe Pecho

Product NDC
58593-235
11-digit product format
585930235
Labeler code
58593
Product ID
58593-235_3e6375e6-6668-3453-e063-6394a90add02
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL
Dosage form
LIQUID
Route
ORAL
Labeler
Efficient Laboratories Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-10-01
Marketing end
2027-03-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10; 100; 5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rompe Pecho
Brand name suffix
CF

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1044949

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58593-235-042023-08-03C16284748780-10191ceaa-62aa-198a-e063-dbdaa90aec3eDrug Facts
58593-235-062023-08-03C16284748780-10191ceaa-62aa-198a-e063-dbdaa90aec3eDrug Facts
58593-235-082023-08-03C16284748780-10191ceaa-62aa-198a-e063-dbdaa90aec3eDrug Facts
58593-235-102023-08-03C16284748780-10191ceaa-62aa-198a-e063-dbdaa90aec3eDrug Facts
58593-235-292023-08-03C16284748780-10191ceaa-62aa-198a-e063-dbdaa90aec3eDrug Facts
58593-235-042023-07-28C16284748780-10191ceaa-62aa-198a-e063-dbdaa90aec3eDrug Facts
58593-235-062023-07-28C16284748780-10191ceaa-62aa-198a-e063-dbdaa90aec3eDrug Facts
58593-235-082023-07-28C16284748780-10191ceaa-62aa-198a-e063-dbdaa90aec3eDrug Facts
58593-235-102023-07-28C16284748780-10191ceaa-62aa-198a-e063-dbdaa90aec3eDrug Facts
58593-235-292023-07-28C16284748780-10191ceaa-62aa-198a-e063-dbdaa90aec3eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-235-04Rompe PechoCF118 mL in 1 BOTTLELIQUID11826
58593-235-06Rompe PechoCF178 mL in 1 BOTTLELIQUID17826
58593-235-08Rompe PechoCF237 mL in 1 BOTTLELIQUID23726
58593-235-10Rompe PechoCF10 mL in 1 POUCHLIQUID1026
58593-235-29Rompe PechoCF296 mL in 1 BOTTLELIQUID29626

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
GUAIFENESINACTIVE INGREDIENT495W7451VQROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
GUAIFENESINACTIVE MOIETY495W7451VQROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
CAULOPHYLLUM THALICTROIDES ROOTINACTIVE INGREDIENTJTJ6HH6YEHROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DXROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
GINKGOINACTIVE INGREDIENT19FUJ2C58TROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JVROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
HONEYINACTIVE INGREDIENTY9H1V576FHROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
HOREHOUNDINACTIVE INGREDIENTK08036XEJVROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3AROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
MYRRHINACTIVE INGREDIENTJC71GJ1F3LROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
PRUNUS SEROTINA BARKINACTIVE INGREDIENT5D48E975HAROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
ULMUS RUBRA BARKINACTIVE INGREDIENT91QY4PXU8QROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
VERBASCUM DENSIFLORUM LEAFINACTIVE INGREDIENT9936O846LIROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
WATERINACTIVE INGREDIENT059QF0KO0RROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TBROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-235ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]25Current NDC, Legacy NDC, 5 package rows20250328_96c4dee1-6e66-4442-a7e3-56e874414c17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044949dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral SolutionPSN96c4dee1-6e66-4442-a7e3-56e874414c1726
1044949dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD96c4dee1-6e66-4442-a7e3-56e874414c1726
1044949dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY96c4dee1-6e66-4442-a7e3-56e874414c1726
1044949dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSY96c4dee1-6e66-4442-a7e3-56e874414c1726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58593-235-0458593023504118 mL in 1 BOTTLE (58593-235-04) 118 ml2015-01-010000-00-00NoNoCurrent
58593-235-0658593023506178 mL in 1 BOTTLE (58593-235-06) 178 ml2007-10-010000-00-00NoNoCurrent
58593-235-0858593023508237 mL in 1 BOTTLE (58593-235-08) 237 ml2015-01-010000-00-00NoNoCurrent
58593-235-105859302351010 mL in 1 POUCH (58593-235-10) 10 ml2019-01-012027-03-31NoNoCurrent
58593-235-2958593023529296 mL in 1 BOTTLE (58593-235-29) 296 ml2015-01-010000-00-00NoNoCurrent