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
Ingredient	Strength
GUAIFENESIN	200 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310604	Internal RxNorm lookup
1112205	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89ea23a5-0da7-407e-83d9-77a0b562f3af	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
58593-829-04	2023-08-03	Drug Facts
58593-829-06	2023-08-03	Drug Facts
58593-829-04	2023-07-28	Drug Facts
58593-829-06	2023-07-28	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58593-829-04	Rompe PechoEX	118 mL in 1 BOTTLE	LIQUID	118		12
58593-829-06	Rompe PechoEX	178 mL in 1 BOTTLE	LIQUID	178		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
ASCLEPIAS TUBEROSA ROOT	INACTIVE INGREDIENT	1ZL82U5D18	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
CAULOPHYLLUM THALICTROIDES ROOT	INACTIVE INGREDIENT	JTJ6HH6YEH	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
ECHINACEA, UNSPECIFIED	INACTIVE INGREDIENT	4N9P6CC1DX	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
EUCALYPTUS GLOBULUS LEAF	INACTIVE INGREDIENT	S546YLW6E6	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
GOLDENSEAL	INACTIVE INGREDIENT	ZW3Z11D0JV	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
HOREHOUND	INACTIVE INGREDIENT	K08036XEJV	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
MYRRH	INACTIVE INGREDIENT	JC71GJ1F3L	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
PRUNUS SEROTINA BARK	INACTIVE INGREDIENT	5D48E975HA	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
ULMUS RUBRA BARK	INACTIVE INGREDIENT	91QY4PXU8Q	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
VERBASCUM DENSIFLORUM LEAF	INACTIVE INGREDIENT	9936O846LI	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1
ZINC SULFATE	INACTIVE INGREDIENT	89DS0H96TB	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58593-829	ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	12	Current NDC, Legacy NDC, 2 package rows	20241116_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 167 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Robitussin Cough Long-Acting	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	75bc7827-4439-e6a8-a65c-7154d5592e58	2024-03-17	Warnings	Exact identifier application number: M012
Childrens Robitussin Nighttime Cough Long-Acting DM	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c	2024-03-17	Warnings	Exact identifier application number: M012
ANTIGRIP Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Pharmadel LLC	12f20aba-f991-bd82-e063-6294a90a4aac	2024-03-16	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	WALGREENS	d3053f80-aece-eb50-e053-2a95a90a5945	2024-03-15	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCL	WALGREENS	d315bc95-1b46-75df-e053-2a95a90a6c66	2024-03-15	Warnings	Exact identifier application number: M012
MAR-COF CG Expectorant	CODEINE PHOSPHATE AND GUAIFENESIN	Marnel Pharmaceuticals, LLC	60a41229-b125-43d8-b2b4-0bf40feed764	2024-03-15	Warnings	Exact identifier application number: M012
Night Time Cough	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY, INC	97aa0b90-1230-4143-b5d3-18b96a6b7b4f	2024-03-15	Warnings	Exact identifier application number: M012
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Haleon US Holdings LLC	036162c9-f5a6-418e-bd5e-ebd72097d27d	2024-03-15	Warnings	Exact identifier application number: M012
Bronkaid Max	EPHEDRINE SULFATE	Foundation Consumer Healthcare LLC	9a0b792a-caee-41f6-9400-922a5ebd592f	2024-03-14	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	A-S Medication Solutions	5f2b16f0-c58b-4e48-ad92-eaab93c6c4b2	2024-03-12	Warnings	Exact identifier application number: M012
Coricidin HBP Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE	A-S Medication Solutions	ffcae882-0b19-4219-bbee-a175c63d79c8	2024-03-11	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime with Honey Ginger Flavor	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	18dcede2-5a38-40fa-93fe-48acdd6a7cf1	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime with Honey Elderberry Flavor	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	d4ce06aa-776f-45e4-a1a6-9cf13797048f	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	14e38ef0-a5e7-4df7-824f-f27bef664d25	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	68d3e88a-d1be-410b-92a1-863903b3aa61	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	0d3b1bea-e2ca-4e07-8ae5-60627d230c96	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu PowerPods Daytime Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Haleon US Holdings LLC	e655c33c-c319-41d9-ae55-cf747242cd10	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime Berry Burst	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	adf33520-4689-4de2-b9d8-c201518e9d26	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	f6ae9e3a-6bea-40e0-8a6f-45f4be8319e7	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb	2024-03-07	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	89ea23a5-0da7-407e-83d9-77a0b562f3af	12
1112205	Rompe Pecho 100 MG in 5 mL Oral Solution	PSN	89ea23a5-0da7-407e-83d9-77a0b562f3af	12
1112205	guaifenesin 20 MG/ML Oral Solution [Rompe Pecho]	SBD	89ea23a5-0da7-407e-83d9-77a0b562f3af	12
310604	guaifenesin 20 MG/ML Oral Solution	SCD	89ea23a5-0da7-407e-83d9-77a0b562f3af	12
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	89ea23a5-0da7-407e-83d9-77a0b562f3af	12
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	89ea23a5-0da7-407e-83d9-77a0b562f3af	12
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	89ea23a5-0da7-407e-83d9-77a0b562f3af	12
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	89ea23a5-0da7-407e-83d9-77a0b562f3af	12
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	89ea23a5-0da7-407e-83d9-77a0b562f3af	12
1112205	Rompe Pecho 100 MG per 5 ML Oral Solution	SY	89ea23a5-0da7-407e-83d9-77a0b562f3af	12
1112205	Rompe Pecho 20 MG/ML Oral Solution	SY	89ea23a5-0da7-407e-83d9-77a0b562f3af	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58593-829-04	58593082904	118 mL in 1 BOTTLE (58593-829-04)	118 ml	2019-04-01	0000-00-00	No	No	Current
58593-829-06	58593082906	178 mL in 1 BOTTLE (58593-829-06)	178 ml	2015-01-01	0000-00-00	No	No	Current