Rompe Pecho

Product NDC: 58593-275
Requested package NDC: 58593-275-10
11-digit product format: 585930275
Labeler code: 58593
Product ID: 58593-275_411e98a6-621c-3e32-e063-6394a90aa647
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: Efficient Laboratories Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2001-10-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 10; 100 mg/5mL; mg/5mL
Pharmacologic classes: 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]
NDC exclude flag: No
Listing certified through: 2026-12-31
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	58593-275	58593-275-10	D	Discontinued by firm		2026-08-03

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Rompe Pecho
Brand name suffix: DM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL
GUAIFENESIN	100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
996520	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
d108c712-bc36-41d7-9ccd-720496b5599e	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
58593-275-04	2023-08-03	Rompe Pecho
58593-275-04	2023-08-03	Rompe Pecho
58593-275-06	2023-08-03	Rompe Pecho
58593-275-06	2023-08-03	Rompe Pecho
58593-275-08	2023-08-03	Rompe Pecho
58593-275-08	2023-08-03	Rompe Pecho
58593-275-10	2023-08-03	Rompe Pecho
58593-275-10	2023-08-03	Rompe Pecho
58593-275-04	2023-07-28	Rompe Pecho
58593-275-04	2023-07-28	Rompe Pecho
58593-275-06	2023-07-28	Rompe Pecho
58593-275-06	2023-07-28	Rompe Pecho
58593-275-08	2023-07-28	Rompe Pecho
58593-275-08	2023-07-28	Rompe Pecho
58593-275-10	2023-07-28	Rompe Pecho
58593-275-10	2023-07-28	Rompe Pecho
58593-275-04	2020-02-16	Rompe Pecho
58593-275-04	2020-02-16	Rompe Pecho
58593-275-06	2020-02-16	Rompe Pecho
58593-275-06	2020-02-16	Rompe Pecho
58593-275-08	2020-02-16	Rompe Pecho
58593-275-08	2020-02-16	Rompe Pecho
58593-275-10	2020-02-16	Rompe Pecho
58593-275-10	2020-02-16	Rompe Pecho
58593-275-04	2020-01-31	Rompe Pecho
58593-275-04	2020-01-31	Rompe Pecho
58593-275-06	2020-01-31	Rompe Pecho
58593-275-06	2020-01-31	Rompe Pecho
58593-275-08	2020-01-31	Rompe Pecho
58593-275-08	2020-01-31	Rompe Pecho
58593-275-10	2020-01-31	Rompe Pecho
58593-275-10	2020-01-31	Rompe Pecho

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58593-275-04	Rompe PechoDM	118 mL in 1 BOTTLE	LIQUID	118	17
58593-275-06	Rompe PechoDM	178 mL in 1 BOTTLE	LIQUID	178	17
58593-275-08	Rompe PechoDM	237 mL in 1 BOTTLE	LIQUID	237	17
58593-275-10	Rompe PechoDM	10 mL in 1 POUCH	LIQUID	10	17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
ASCLEPIAS TUBEROSA ROOT	INACTIVE INGREDIENT	1ZL82U5D18	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
CAULOPHYLLUM THALICTROIDES ROOT	INACTIVE INGREDIENT	JTJ6HH6YEH	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
ECHINACEA, UNSPECIFIED	INACTIVE INGREDIENT	4N9P6CC1DX	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
EUCALYPTUS GLOBULUS LEAF	INACTIVE INGREDIENT	S546YLW6E6	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
GOLDENSEAL	INACTIVE INGREDIENT	ZW3Z11D0JV	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
MYRRH	INACTIVE INGREDIENT	JC71GJ1F3L	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
PROPOLIS WAX	INACTIVE INGREDIENT	6Y8XYV2NOF	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
PRUNUS SEROTINA BARK	INACTIVE INGREDIENT	5D48E975HA	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
SPEARMINT	INACTIVE INGREDIENT	J7I2T6IV1N	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
ULMUS RUBRA BARK	INACTIVE INGREDIENT	91QY4PXU8Q	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
VERBASCUM DENSIFLORUM LEAF	INACTIVE INGREDIENT	9936O846LI	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5
ZINC SULFATE	INACTIVE INGREDIENT	89DS0H96TB	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58593-275	ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]	16	Current NDC, Legacy NDC, 4 package rows	20241012_d108c712-bc36-41d7-9ccd-720496b5599e.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 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	ce590997-3cae-4f22-ac39-2b14d39494bc	2026-07-30	Warnings	Exact identifier application number: M012
Robitussin Direct Cough	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	70c9556b-063a-4fb3-96f6-1d4ffa495ed4	2026-07-30	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a302e341-1c00-4c3d-b71f-c4c0b307aa67	2026-07-29	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	4c737cd6-fe56-4cef-887c-cd6cf83b254c	2026-07-29	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGHGELS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	472c5c1f-eb5a-444b-a17e-f0d71007fb15	2026-07-29	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Meijer Distribution Inc	3a33c6ce-aada-4099-8c61-49c86c0fc1a8	2026-07-29	Warnings	Exact identifier application number: M012
Tussin DM Max Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	668c92ce-6c1f-4ab3-b0dd-822b0768cb5e	2026-07-29	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	702f9786-7ce9-43e4-921d-e1db09612127	2026-07-28	Warnings	Exact identifier application number: M012
LoHist-D	CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL	Larken Laboratories, Inc.	efaa354e-c25c-405b-9d30-001c2796978c	2026-07-28	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d1115a55-35cd-4f20-8872-f42983a5ebcd	2026-07-28	Warnings	Exact identifier application number: M012
TUSSIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Safeway	a5e2bda4-2da6-4c20-855d-2888dadf0c3a	2026-07-28	Warnings	Exact identifier application number: M012
DM Maximum	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f6029b04-e681-40fc-be4f-14091b76dd4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CVS PHARMACY	e958eef1-8aae-4365-ac64-95a9e8e7e0f2	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	38400854-27fa-e291-e063-6294a90a5c4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Better Living Brands, LLC	65802aa7-64e7-4435-ad6b-65895fba17ce	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	0a48f650-ad2a-4105-9ff4-2bc4d94b46d3	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	84202ebe-97b6-4be2-bb09-7f2729303f96	2026-07-27	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	8d41defe-8120-4cbb-b42e-c805cc5a794b	2026-07-24	Warnings	Exact identifier application number: M012
Childrens Benadryl ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	fc9181b9-c92d-493e-8d7c-4a4239c6c092	2026-07-24	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	3afc88c7-388a-dbd9-e063-6294a90a4faf	2026-07-24	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	d108c712-bc36-41d7-9ccd-720496b5599e	17
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	d108c712-bc36-41d7-9ccd-720496b5599e	17
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	d108c712-bc36-41d7-9ccd-720496b5599e	17
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	d108c712-bc36-41d7-9ccd-720496b5599e	17
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	d108c712-bc36-41d7-9ccd-720496b5599e	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58593-275-10	58593027510	10 mL in 1 POUCH (58593-275-10)	10 ml	2001-10-01	0000-00-00	No	No	Current