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 23 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theraflu Severe Congestion Relief Cooling Nasal Mist	OXYMETAZOLINE HCL	Haleon US Holdings LLC	90125a19-eed7-4ca4-a6dc-f38026c74d54	2026-06-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	54254b61-7861-4eeb-bd3c-54fd5266f4a7	2026-06-08	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Major Pharmaceuticals	aa662428-e61f-4e22-af4d-8cf63df68c99	2026-06-08	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN, GUAIFENESIN AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	TARGET CORPORATION	47a218a0-6395-36bd-e063-6394a90a265a	2026-06-05	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL	TARGET CORPORATION	4779288a-9850-8490-e063-6394a90abe51	2026-06-05	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max and Mucinex Fast-Max Nighttime DM Max Value Pack	DEXTROMETHORPHAN HBR, GUAIFENESIN AND TRIPROLIDINE HCL	Reckitt Benckiser LLC	4df37cfb-299f-661f-e063-6394a90ab337	2026-06-04	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	53715ea4-42b3-5887-e063-6294a90a4249	2026-06-04	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Chain Drug Marketing Association, Inc.	b0d38db9-22a9-4dd8-8e0f-dd81805e724b	2026-06-04	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS PHARMACY	65d4d7ea-c080-404e-9836-7d6bdcc5ea7d	2026-06-04	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	fe9d6a6e-38a1-44ae-a30f-596c5ec7d057	2026-06-03	Warnings	Exact identifier application number: M012
Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	b0c1d635-0f85-433a-b479-51c68d259faa	2026-06-03	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Walgreen Company	de4e8af4-d3d0-44b3-aea3-79016803ccdc	2026-06-03	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR AND GUAIFENESIN	ARMY AND AIR FORCE EXCHANGE SERVICE	dc0a3761-bbe2-4261-a183-594f5fb12b0b	2026-06-03	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	WALMART INC.	f278cc81-65b2-4e45-be5b-41152cbb67c4	2026-06-03	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	358ba91d-06a4-49c9-994d-4e4bf9499dcd	2026-06-03	Warnings	Exact identifier application number: M012
GUAIFENESIN DM	GUAIFENESIN AND DEXTROMETHORPHAN	Cardinal Health 107, LLC	c5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed	2026-06-02	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5349dbde-730c-610f-e063-6394a90a952a	2026-06-02	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	Cardinal Health 107, LLC	a9130f36-4761-4e6b-a383-eca3db06ea93	2026-06-02	Warnings	Exact identifier application number: M012
Topcare Day Time Nite Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Topco Associates LLC	aed387e0-5a8b-4caf-a373-3e04496a4983	2026-06-02	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid Day	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	53371691-2510-5039-e063-6394a90a6ea9	2026-06-01	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