Rompe Pecho

Product NDC
58593-275
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58593-27558593-275-04DDiscontinued by firm2026-08-17
excluded packagepackage58593-27558593-275-08DDiscontinued by firm2026-08-17
excluded packagepackage58593-27558593-275-10DDiscontinued by firm2026-08-17

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 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0558593-275-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0558593-275-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0558593-275-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2658593-275-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2658593-275-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2658593-275-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3158593-275-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3158593-275-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3158593-275-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2858593-275-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2858593-275-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2858593-275-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2158593-275-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2158593-275-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2158593-275-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1058593-275-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1058593-275-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1058593-275-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3158593-275-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3158593-275-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3158593-275-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2058593-275-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2058593-275-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2058593-275-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1058593-275-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1058593-275-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1058593-275-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0858593-275-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0858593-275-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0858593-275-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0358593-275-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0358593-275-08367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0358593-275-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0958593-275-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0958593-275-08557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0958593-275-10557ba5c1ecfa…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
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996520Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d108c712-bc36-41d7-9ccd-720496b5599eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-275-04Rompe PechoDM118 mL in 1 BOTTLELIQUID11817
58593-275-06Rompe PechoDM178 mL in 1 BOTTLELIQUID17817
58593-275-08Rompe PechoDM237 mL in 1 BOTTLELIQUID23717
58593-275-10Rompe PechoDM10 mL in 1 POUCHLIQUID1017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
GUAIFENESINACTIVE INGREDIENT495W7451VQROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
GUAIFENESINACTIVE MOIETY495W7451VQROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
ASCLEPIAS TUBEROSA ROOTINACTIVE INGREDIENT1ZL82U5D18ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
CAULOPHYLLUM THALICTROIDES ROOTINACTIVE INGREDIENTJTJ6HH6YEHROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DXROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
GINKGOINACTIVE INGREDIENT19FUJ2C58TROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JVROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
HONEYINACTIVE INGREDIENTY9H1V576FHROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3AROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
MYRRHINACTIVE INGREDIENTJC71GJ1F3LROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOFROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
PRUNUS SEROTINA BARKINACTIVE INGREDIENT5D48E975HAROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
SPEARMINTINACTIVE INGREDIENTJ7I2T6IV1NROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
ULMUS RUBRA BARKINACTIVE INGREDIENT91QY4PXU8QROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
VERBASCUM DENSIFLORUM LEAFINACTIVE INGREDIENT9936O846LIROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
WATERINACTIVE INGREDIENT059QF0KO0RROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5
ZINC SULFATEINACTIVE INGREDIENT89DS0H96TBROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-275ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]16Current NDC, Legacy NDC, 4 package rows20241012_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 196 · 3,909 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH464534ee-15f8-3af8-e063-6394a90a3f182026-08-24WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
Afrin Original NasalOXYMETAZOLINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.ecfa14b8-a3f3-4569-b489-c9e1a51cf09e2026-08-20WarningsExact identifier
application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACKBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCLCVS PHARMACY, INC.4d94968b-ada3-4344-8563-cba7fc491d742026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
application number: M012
CVS Long Acting CoughDEXTROMETHORPHAN HBRCVS PHARMACY, INC31a7c0e2-af1c-45dd-8a93-e0879cae60052026-08-19WarningsExact identifier
application number: M012
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY5151127a-4d09-413a-a08b-f76fb77e11882026-08-19WarningsExact identifier
application number: M012
CVS DT and NT Combo Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY360c8c62-0945-4031-b291-d40c4270b9402026-08-19WarningsExact identifier
application number: M012
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY4490a7e1-d5b9-459c-8751-c244868079812026-08-19WarningsExact identifier
application number: M012
CVS DayTime and NightTime Value Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY4c813cd5-2c97-4fc3-926c-1a0396551a312026-08-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNd108c712-bc36-41d7-9ccd-720496b5599e17
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDd108c712-bc36-41d7-9ccd-720496b5599e17
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYd108c712-bc36-41d7-9ccd-720496b5599e17
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYd108c712-bc36-41d7-9ccd-720496b5599e17
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYd108c712-bc36-41d7-9ccd-720496b5599e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58593-275-0458593027504118 mL in 1 BOTTLE (58593-275-04) 118 ml2015-01-010000-00-00NoNoCurrent
58593-275-0658593027506178 mL in 1 BOTTLE (58593-275-06) 178 ml2001-10-010000-00-00NoNoCurrent
58593-275-0858593027508237 mL in 1 BOTTLE (58593-275-08) 237 ml2015-01-010000-00-00NoNoCurrent
58593-275-105859302751010 mL in 1 POUCH (58593-275-10) 10 ml2001-10-010000-00-00NoNoCurrent