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 | 2026-10-21 | |
| excluded package | package | 58593-235 | 58593-235-06 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 58593-235 | 58593-235-08 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 58593-235 | 58593-235-29 | D | Discontinued by firm | 2026-10-21 |
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 |
|---|---|---|---|---|---|---|
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 8188b66a-5405-4e62-bde6-63ebc1f22b16 | 2025-07-04 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Meijer, Inc. | fdeadc2e-43e4-40d5-aebf-0e528f0a8b5a | 2025-07-03 | Warnings | M012 |
| Cabinet Allergy Relief Refill Diphenhydramine HCI | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | d47553a4-ca15-4f0a-8177-d743a5c39cc5 | 2025-07-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Advanced Rx LLC | 20e164b8-4cbc-cf3f-e063-6394a90a9d0c | 2025-07-02 | Warnings | M012 |
| 24/7 Life Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENT | Lil' Drug Store Products, Inc. | f03430d4-8dbb-4fc0-e053-2a95a90a119d | 2025-07-02 | Warnings | M012 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | KJD Pharma Private Limited | b109249a-a0be-41bd-b6ce-ef621b588ddc | 2025-07-02 | Warnings | M012 |
| Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS Pharmacy | 91c803c8-6cf8-4ff6-b376-ea6d65f9f227 | 2025-07-01 | Warnings | M012 |
| WALGREENS Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALGREENS CO. | cc2fdc6b-8319-47c8-b036-37dbd65d5833 | 2025-06-30 | Warnings | M012 |
| WALGREENS Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALGREENS CO. | 91c369b0-8620-4764-a85d-a86402d9489c | 2025-06-30 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCl 25mg SoftGel | DIPHENHYDRAMINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | bb9a82b1-ea7a-4d10-bc00-05013e83c4d3 | 2025-06-30 | Warnings | M012 |
| Daytime and Nighttime Cherry Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS, LLC | 202f0661-461c-0333-e063-6294a90a96b5 | 2025-06-28 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | CVS Pharmacy | f038b713-0721-2bb5-e053-2a95a90a7842 | 2025-06-26 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCl 25mg SoftGel | DIPHENHYDRAMINE HYDROCHLORIDE | NUVICARE LLC | bb728ceb-8eb0-4192-a8b0-742756819a05 | 2025-06-26 | Warnings | M012 |
| ALLERGY RELIEF | DIPHENHYDRAMINE HYDROCHLORIDE | TIME CAP LABORATORIES, INC | 7aee34b5-1583-4a8a-8ffb-b17ef2722ac1 | 2025-06-25 | Warnings | M012 |
| ALLERGY RELIEF | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREENS | c0270298-e7c5-e500-e053-2995a90aed23 | 2025-06-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walmart Inc. | 24ff91f2-02db-56a2-e063-6394a90a31c9 | 2025-06-25 | Warnings | M012 |
| Cough and Chest Congestion Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | e920b700-30d3-3266-e053-2a95a90a0639 | 2025-06-24 | Warnings | M012 |
| good sense childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | L. Perrigo Company | 2ffe0fbc-236d-417b-bbfd-5b9294f3c90a | 2025-06-23 | Warnings | M012 |
| Exchange Select Cough Drop Black Cherry Sugar Free | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 38034ad2-5eab-9caf-e063-6294a90abb8f | 2025-06-20 | Warnings | M012 |
| Herbal Cough Drops | HERBAL MENTHOL | Meijer, Inc. | 380364be-4e52-fa52-e063-6394a90a713c | 2025-06-20 | 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 |