Rompe Pecho

Product NDC: 58593-265
11-digit product format: 585930265
Labeler code: 58593
Product ID: 58593-265_411e96f1-d9a3-1820-e063-6294a90a8a69
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: 1999-03-01
Substance: GUAIFENESIN
Active strength: 100 mg/5mL
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58593-265	58593-265-04	D	Discontinued by firm		2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: SF
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	100 mg/5mL

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
31ff48fc-9603-413c-ab7c-2598b3e08f9c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
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
58593-265-04	2023-08-03	Drug Facts
58593-265-04	2023-08-03	Drug Facts
58593-265-06	2023-08-03	Drug Facts
58593-265-06	2023-08-03	Drug Facts
58593-265-04	2023-07-28	Drug Facts
58593-265-04	2023-07-28	Drug Facts
58593-265-06	2023-07-28	Drug Facts
58593-265-06	2023-07-28	Drug Facts
58593-265-04	2020-02-16	Drug Facts
58593-265-04	2020-02-16	Drug Facts
58593-265-06	2020-02-16	Drug Facts
58593-265-06	2020-02-16	Drug Facts
58593-265-04	2020-01-31	Drug Facts
58593-265-04	2020-01-31	Drug Facts
58593-265-06	2020-01-31	Drug Facts
58593-265-06	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58593-265-04	Rompe PechoSF	118 mL in 1 BOTTLE	LIQUID	118		15
58593-265-06	Rompe PechoSF	178 mL in 1 BOTTLE	LIQUID	178		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
CAULOPHYLLUM THALICTROIDES ROOT	INACTIVE INGREDIENT	JTJ6HH6YEH	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
ECHINACEA, UNSPECIFIED	INACTIVE INGREDIENT	4N9P6CC1DX	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
GOLDENSEAL	INACTIVE INGREDIENT	ZW3Z11D0JV	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
HOREHOUND	INACTIVE INGREDIENT	K08036XEJV	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
MYRRH	INACTIVE INGREDIENT	JC71GJ1F3L	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
PRUNUS SEROTINA BARK	INACTIVE INGREDIENT	5D48E975HA	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
ULMUS RUBRA BARK	INACTIVE INGREDIENT	91QY4PXU8Q	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
VERBASCUM DENSIFLORUM LEAF	INACTIVE INGREDIENT	9936O846LI	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4
ZINC SULFATE	INACTIVE INGREDIENT	89DS0H96TB	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58593-265	ROMPE PECHO SF (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20241016_31ff48fc-9603-413c-ab7c-2598b3e08f9c.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 120 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menthol Cough Drops Honey Vanilla Flavor	MENTHOL	7-ELEVEN	2f3c43dd-175f-722e-e063-6294a90acff9	2025-02-28	Warnings	Exact identifier application number: M012
Menthol Cough Drops Creamy Strawberry Flavor	MENTHOL AND PECTIN	7-ELEVEN	2f3c3c65-4178-6304-e063-6294a90a51fa	2025-02-28	Warnings	Exact identifier application number: M012
Menthol Cough Drops Creamy Strawberry Flavor	MENTHOL AND PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2efbffd7-bbdd-c5f5-e063-6294a90a15f0	2025-02-25	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Vanilla Flavor	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2efc46c9-a421-1998-e063-6394a90aeb64	2025-02-25	Warnings	Exact identifier application number: M012
Redicare Cough Drops Cherry Flavored	CHERRY FLAVORED MENTHOL COUGH DROPS	Redicare LLC	2efeaafa-ee96-37ee-e063-6394a90a9a4b	2025-02-25	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Genexa Inc.	e880b8d7-61c3-41cc-e053-2995a90aaaeb	2025-02-20	Warnings	Exact identifier application number: M012
Gencare-Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	596ec923-56a0-4b6e-a69c-8d740feb75a2	2025-02-20	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	77a2dc96-73ee-4ca2-b1fe-406995802606	2025-02-19	Warnings	Exact identifier application number: M012
nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	f1d0edd5-fe58-4de0-98f4-07fb24bd0ac2	2025-02-19	Warnings	Exact identifier application number: M012
Coricidin HBP Cold and Flu	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	Bayer HealthCare LLC.	763a5334-a741-4678-9947-603776622450	2025-02-18	Warnings	Exact identifier application number: M012
Sof Skin Vaporizing Chest Rub and Cough Suppressant	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Viny Health and Beauty Inc	46ae16a4-b8a7-44de-ae1a-9bb503c15ea0	2025-02-18	Warnings	Exact identifier application number: M012
Pain Reliever PM	ACETAMINOPHEN DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	4897d1df-4fb3-46e2-bbf0-847e964dca0a	2025-02-18	Warnings	Exact identifier application number: M012
meijer EXTRA STRENGTH Pain Relief PM Caplet	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1bee7e4f-1813-1bdf-e063-6294a90a6a32	2025-02-17	Warnings	Exact identifier application number: M012
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL	Kroger Company	a24f09d9-60f1-853a-e053-2a95a90ae1fa	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH COLD AND FLU	ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	FAMILY DOLLAR SERVICES	a7343bea-53cc-4621-e053-2a95a90a2a5f	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL	FAMILY DOLLAR	aa8f6dd0-d19f-0c10-e053-2a95a90a1e8a	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENGHT DAY COLD AND FLU FORMULA	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL	FAMILY DOLLAR	aa8ebccf-6813-2dca-e053-2a95a90a032b	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	FAMILY DOLLAR	aa8f0465-1595-0b0f-e053-2a95a90a0081	2025-02-15	Warnings	Exact identifier application number: M012
DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN	KROGER COMPANY	9bb7aaf0-6698-9a5c-e053-2a95a90a097c	2025-02-14	Warnings	Exact identifier application number: M012
Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H-E-B	db432947-fe02-79b2-e053-2a95a90af4a9	2025-02-14	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	31ff48fc-9603-413c-ab7c-2598b3e08f9c	15
1112205	Rompe Pecho 100 MG in 5 mL Oral Solution	PSN	31ff48fc-9603-413c-ab7c-2598b3e08f9c	15
1112205	guaifenesin 20 MG/ML Oral Solution [Rompe Pecho]	SBD	31ff48fc-9603-413c-ab7c-2598b3e08f9c	15
310604	guaifenesin 20 MG/ML Oral Solution	SCD	31ff48fc-9603-413c-ab7c-2598b3e08f9c	15
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	31ff48fc-9603-413c-ab7c-2598b3e08f9c	15
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	31ff48fc-9603-413c-ab7c-2598b3e08f9c	15
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	31ff48fc-9603-413c-ab7c-2598b3e08f9c	15
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	31ff48fc-9603-413c-ab7c-2598b3e08f9c	15
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	31ff48fc-9603-413c-ab7c-2598b3e08f9c	15
1112205	Rompe Pecho 100 MG per 5 ML Oral Solution	SY	31ff48fc-9603-413c-ab7c-2598b3e08f9c	15
1112205	Rompe Pecho 20 MG/ML Oral Solution	SY	31ff48fc-9603-413c-ab7c-2598b3e08f9c	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58593-265-04	58593026504	118 mL in 1 BOTTLE (58593-265-04)	118 ml	2015-01-01	0000-00-00	No	No	Current
58593-265-06	58593026506	178 mL in 1 BOTTLE (58593-265-06)	178 ml	1999-03-01	0000-00-00	No	No	Current