FDA.reportPublic FDA data

Rompe Pecho Max Multi Symptoms

Product NDC
58593-828
11-digit product format
585930828
Labeler code
58593
Product ID
58593-828_265921fa-a795-0300-e063-6294a90a6793
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethophan HBr, Phenylephrine HCl, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
EFFICIENT LABORATORIES INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rompe Pecho Max Multi Symptoms
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1593450

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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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
58593-828-082023-08-03C16284748780-19d75b9cf-dbc8-f424-e053-dadaa90a57ce938e4e47-d2d9-4b0d-bf88-e9f41b501945
58593-828-082023-07-28C16284748780-19d75b9cf-dbc8-f424-e053-dadaa90a57ce938e4e47-d2d9-4b0d-bf88-e9f41b501945
58593-828-082020-02-16C16284748780-19d75b9cf-dbc8-f424-e053-dadaa90a57ce938e4e47-d2d9-4b0d-bf88-e9f41b501945
58593-828-082020-01-31C16284748780-19d75b9cf-dbc8-f424-e053-dadaa90a57ce938e4e47-d2d9-4b0d-bf88-e9f41b501945

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-828-08Rompe Pecho Max Multi Symptoms1 in 1 CARTONLIQUID110
58593-828-08Rompe Pecho Max Multi Symptoms237 mL in 1 BOTTLELIQUID23710

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
GUAIFENESINACTIVE MOIETY495W7451VQROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
CAULOPHYLLUM THALICTROIDES ROOTINACTIVE INGREDIENTJTJ6HH6YEHROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DXROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662ROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
GINKGOINACTIVE INGREDIENT19FUJ2C58TROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JVROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
HONEYINACTIVE INGREDIENTY9H1V576FHROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
HOREHOUNDINACTIVE INGREDIENTK08036XEJVROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
LICORICEINACTIVE INGREDIENT61ZBX54883ROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
MULLEIN LEAFINACTIVE INGREDIENT9936O846LIROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
MYRRHINACTIVE INGREDIENTJC71GJ1F3LROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
PRUNUS SEROTINA BARKINACTIVE INGREDIENT5D48E975HAROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
ULMUS RUBRA BARKINACTIVE INGREDIENT91QY4PXU8QROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
WATERINACTIVE INGREDIENT059QF0KO0RROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TBROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-828ROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]10Current NDC, Legacy NDC, 2 package rows20241109_938e4e47-d2d9-4b0d-bf88-e9f41b501945.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593450acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral SuspensionPSN938e4e47-d2d9-4b0d-bf88-e9f41b50194510
1593450acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SuspensionSCD938e4e47-d2d9-4b0d-bf88-e9f41b50194510
1593450acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SuspensionSY938e4e47-d2d9-4b0d-bf88-e9f41b50194510
1593450acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SuspensionSY938e4e47-d2d9-4b0d-bf88-e9f41b50194510
1593450APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SuspensionSY938e4e47-d2d9-4b0d-bf88-e9f41b50194510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58593-828-08585930828081 BOTTLE in 1 CARTON (58593-828-08) / 237 mL in 1 BOTTLE1 bottle2014-01-010000-00-00NoNoCurrent