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 | 2026-10-23 | |
| excluded package | package | 58593-235 | 58593-235-06 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 58593-235 | 58593-235-08 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 58593-235 | 58593-235-29 | D | Discontinued by firm | 2026-10-23 |
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 |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Navajo Manufacturing Company Inc. | f6068011-ad56-59b4-e053-2995a90ac016 | 2024-10-03 | Warnings | M012 |
| Benadryl Ultratabs | DIPHENHYDRAMINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 76433e3c-142c-4704-8b2b-d602f008c377 | 2024-10-02 | Warnings | M012 |
| Afrin | OXYMETAZOLINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 65bf1556-f234-9439-e053-2a91aa0a3194 | 2024-10-02 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | Proficient Rx LP | 4eab4344-d95e-4b19-a21e-9c8ad033863a | 2024-10-01 | Warnings | M012 |
| pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HCL | Proficient Rx LP | a910320b-0585-40bd-928c-0406346281d0 | 2024-10-01 | Warnings | M012 |
| CareOne Nasal and Sinus Decongestant | PSEUDOEPHEDRINE HCL | American Sales Company | 81b31070-9b03-4ce4-8aac-a334544842ae | 2024-10-01 | Warnings | M012 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | Proficient Rx LP | 20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d | 2024-10-01 | Warnings | M012 |
| meijer Nighttime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 1bec5167-5fc5-2405-e063-6294a90a5358 | 2024-09-30 | Warnings | M012 |
| good sense tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | A-S Medication Solutions | 19b3db33-86d1-48f3-9525-c7c87a4b6899 | 2024-09-29 | Warnings | M012 |
| nasal decongestant maximum strength non drowsy | PSEUDOEPHEDRINE HCL | Meijer Distribution Inc | 8a68ca99-fd76-409a-9769-88830e8720a8 | 2024-09-28 | Warnings | M012 |
| good neighbor pharmacy tussin dm max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amerisource Bergen | 58687394-b6d2-4d51-bde0-8f2cfa3fe909 | 2024-09-27 | Warnings | M012 |
| good neighbor pharmacy nasal | OXYMETAZOLINE HYDROCHLORIDE | Amerisource Bergen | faee3aae-e819-4084-a127-3449be353b13 | 2024-09-27 | Warnings | M012 |
| Tesalon Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCL | OPMX LLC | 2309620a-ccbc-41e9-e063-6394a90a9520 | 2024-09-26 | Warnings | M012 |
| adult cough and chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Meijer, Inc. | b11c4cee-bbb5-4585-9d38-6787553e13a0 | 2024-09-26 | Warnings | M012 |
| COLD AND FLU NIGHTTIME SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORP | 9de9c34e-a0ca-cdf9-e053-2a95a90a93d3 | 2024-09-25 | Warnings | M012 |
| Basic Care Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amazon.com Services LLC | 8f3317f6-4ae8-474b-93c3-25e256519cb8 | 2024-09-25 | Warnings | M012 |
| berkley and jensen tussin dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | BJWC | b2de91c9-6af0-4881-8d2d-a69d90c8dfcd | 2024-09-24 | Warnings | M012 |
| Tussin DM Cough and Chest Non Drowsy | DEXTROMETHORPHAN HBR, GUAIFENESIN | WinCo Foods, LLC | 13eb459c-3075-4038-8062-9ee7175b2ab9 | 2024-09-24 | Warnings | M012 |
| equaline nasal decongestant non drowsy maximum strength | PSEUDOEPHEDRINE HCL | United Natural Foods, Inc. dba UNFI | 8897580a-709a-4643-8264-ad003d90cbff | 2024-09-22 | Warnings | M012 |
| Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Dabur India Limited | 22916978-303d-e62a-e063-6394a90a2100 | 2024-09-20 | 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 |