Rompe Pecho
- Product NDC
- 58593-235
- 11-digit product format
- 585930235
- Labeler code
- 58593
- Product ID
- 58593-235_3e6375e6-6668-3453-e063-6394a90add02
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Efficient Laboratories Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2007-10-01
- Marketing end
- 2027-03-31
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10; 100; 5 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 58593-235 | 58593-235-04 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 58593-235 | 58593-235-06 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 58593-235 | 58593-235-08 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 58593-235 | 58593-235-29 | 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.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 58593-235-29 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 58593-235-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 58593-235-08 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 58593-235-06 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 58593-235-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 58593-235-29 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 58593-235-08 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 58593-235-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 58593-235-29 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 58593-235-08 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 58593-235-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 58593-235-29 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 58593-235-08 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 58593-235-04 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 58593-235-29 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 58593-235-08 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 58593-235-04 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 58593-235-29 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 58593-235-08 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 58593-235-04 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 58593-235-29 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 58593-235-08 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 58593-235-04 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 58593-235-29 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 58593-235-08 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 58593-235-04 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 58593-235-29 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 58593-235-08 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 58593-235-04 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 58593-235-29 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 58593-235-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 58593-235-08 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 58593-235-04 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 58593-235-08 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 58593-235-04 | 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
- CF
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| GUAIFENESIN | 100 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1044949 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 96c4dee1-6e66-4442-a7e3-56e874414c17 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 58593-235-04 | 2023-08-03 | Drug Facts |
| 58593-235-06 | 2023-08-03 | Drug Facts |
| 58593-235-08 | 2023-08-03 | Drug Facts |
| 58593-235-10 | 2023-08-03 | Drug Facts |
| 58593-235-29 | 2023-08-03 | Drug Facts |
| 58593-235-04 | 2023-07-28 | Drug Facts |
| 58593-235-06 | 2023-07-28 | Drug Facts |
| 58593-235-08 | 2023-07-28 | Drug Facts |
| 58593-235-10 | 2023-07-28 | Drug Facts |
| 58593-235-29 | 2023-07-28 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58593-235-04 | Rompe PechoCF | 118 mL in 1 BOTTLE | LIQUID | 118 | 26 | |
| 58593-235-06 | Rompe PechoCF | 178 mL in 1 BOTTLE | LIQUID | 178 | 26 | |
| 58593-235-08 | Rompe PechoCF | 237 mL in 1 BOTTLE | LIQUID | 237 | 26 | |
| 58593-235-10 | Rompe PechoCF | 10 mL in 1 POUCH | LIQUID | 10 | 26 | |
| 58593-235-29 | Rompe PechoCF | 296 mL in 1 BOTTLE | LIQUID | 296 | 26 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Leader Throat Soothing Drops Creamy Strawberry | THROAT SOOTHING CREAMY STRAWBERRY | Cardinal Health 110, LLC. DBA Leader | 26cd146a-6461-604f-e063-6394a90ac36e | 2025-12-22 | Warnings | M012 |
| MGC Health | COUGH DROPS CREAMY STRAWBERRY | Medical Group Care LLC | 043a5e11-30c3-44cd-e063-6394a90a318b | 2025-12-22 | Warnings | M012 |
| MGC Health | COUGH DROPS CHERRY | Medical Group Care LLC | 29f3f6dd-751e-1dfe-e063-6394a90a0dbb | 2025-12-22 | Warnings | M012 |
| MGC Cough Drops | MENTHOL | Medical Group Care LLC | 437f6b77-ecf8-2cd8-e063-6394a90ad45d | 2025-12-22 | Warnings | M012 |
| MGC Health | COUGH DROPS HONEY | Medical Group Care LLC | f4a92a69-e562-1cec-e053-2a95a90a0165 | 2025-12-22 | Warnings | M012 |
| MGC Health | COUGH DROPS VANILLA HONEY | Medical Group Care LLC | 043999bc-3efe-5d29-e063-6294a90a95f4 | 2025-12-22 | Warnings | M012 |
| MGC Health Throat Soothing Drops Creamy Strawberry | PECTIN | Medical Group Care LLC | 3fa195b5-0712-aada-e063-6394a90a9069 | 2025-12-22 | Warnings | M012 |
| QUALITY CHOICE Cough Drops Creamy Strawberry | PECTIN, MENTHOL | Chain Drug Marketing Association, Inc. | 18d28b91-55a7-4d0d-8404-4f21afdef989 | 2025-12-22 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS CHERRY | DISCOUNT DRUG MART | 0668492e-c47e-b7cf-e063-6394a90a309b | 2025-12-22 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS MENTHOL | DISCOUNT DRUG MART | 06574e56-13b8-a3af-e063-6394a90a4867 | 2025-12-22 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS HONEY LEMON | DISCOUNT DRUG MART | 0668ddcc-0214-8e97-e063-6294a90a4f32 | 2025-12-22 | Warnings | M012 |
| caring mill Cough drops CHERRY | MENTHOL | FSA STORE INC. | 9d666061-f7a8-4318-8db1-b65373689e1d | 2025-12-22 | Warnings | M012 |
| Premier Value | COUGH DROPS CHERRY | Pharmacy Value Alliance LLC | 018f4790-8785-94f4-e063-6394a90a1916 | 2025-12-22 | Warnings | M012 |
| Premier Value | COUGH DROPS HONEY LEMON | Pharmacy Value Alliance LLC | 0191fcf7-abc1-e583-e063-6294a90a7854 | 2025-12-22 | Warnings | M012 |
| Premier Value | COUGH DROPS MENTHOL | Pharmacy Value Alliance LLC | 019211bf-dd4b-5f4c-e063-6294a90aacfb | 2025-12-22 | Warnings | M012 |
| Premier Value | COUGH DROPS BLACK CHERRY SUGAR FREE | Pharmacy Value Alliance LLC | 018f20b1-06e0-eb13-e063-6394a90a5ec5 | 2025-12-22 | Warnings | M012 |
| Quality Choice Cherry Cough Drops | CHERRY COUGH DROPS | Chain Drug Marketing Association, Inc. | 6a407092-4b71-4156-b4ad-930782b5fb43 | 2025-12-22 | Warnings | M012 |
| Quality Choice Honey Lemon Cough Drops | HONEY LEMON COUGH DROPS | Chain Drug Marketing Association, Inc. | 1fd09b04-9c79-da20-e063-6394a90ae263 | 2025-12-22 | Warnings | M012 |
| Quality Choice Menthol Cough Drops | MENTHOL COUGH DROPS | Chain Drug Marketing Association, Inc. | 3364470e-d9bb-42a6-9bd5-80c0bed8bc9e | 2025-12-22 | Warnings | M012 |
| Quality Choice Honey Lemon Sugar Free Cough Drops | HONEY LEMON SUGAR FREE COUGH DROPS | Chain Drug Marketing Association, Inc. | 1fd0a790-c67c-216f-e063-6294a90ae971 | 2025-12-22 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1044949 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral Solution | PSN | 96c4dee1-6e66-4442-a7e3-56e874414c17 | 26 |
| 1044949 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution | SCD | 96c4dee1-6e66-4442-a7e3-56e874414c17 | 26 |
| 1044949 | dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution | SY | 96c4dee1-6e66-4442-a7e3-56e874414c17 | 26 |
| 1044949 | dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral Solution | SY | 96c4dee1-6e66-4442-a7e3-56e874414c17 | 26 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58593-235-04 | 58593023504 | 118 mL in 1 BOTTLE (58593-235-04) | 118 ml | 2015-01-01 | 0000-00-00 | No | No | Current |
| 58593-235-06 | 58593023506 | 178 mL in 1 BOTTLE (58593-235-06) | 178 ml | 2007-10-01 | 0000-00-00 | No | No | Current |
| 58593-235-08 | 58593023508 | 237 mL in 1 BOTTLE (58593-235-08) | 237 ml | 2015-01-01 | 0000-00-00 | No | No | Current |
| 58593-235-10 | 58593023510 | 10 mL in 1 POUCH (58593-235-10) | 10 ml | 2019-01-01 | 2027-03-31 | No | No | Current |
| 58593-235-29 | 58593023529 | 296 mL in 1 BOTTLE (58593-235-29) | 296 ml | 2015-01-01 | 0000-00-00 | No | No | Current |