Rompe Pecho
- Product NDC
- 58593-225
- 11-digit product format
- 585930225
- Labeler code
- 58593
- Product ID
- 58593-225_3144d03d-22a8-08bf-e063-6394a90a57c4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan, Brompheniramine Maleate, Phenylephrine Hydrochloride
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Efficient Laboratories Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2007-10-01
- Marketing end
- 2026-10-31
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10; 10; 10 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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
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
- SF FLU
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| BROMPHENIRAMINE MALEATE | 10 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| IXA7C9ZN03 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bc10695a-9664-4ce3-82bb-820da06129fa | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-08-03 | Drug Facts |
| 2023-07-28 | Drug Facts |
| 2020-02-18 | Drug Facts |
| 2020-01-31 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58593-225-06 | Rompe PechoSF FLU | 178 mL in 1 BOTTLE | LIQUID | 178 | 17 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58593-225 | ROMPE PECHO SF FLU (DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EFFICIENT LABORATORIES INC] | 17 | Current NDC, Legacy NDC, 1 package rows | 20250328_bc10695a-9664-4ce3-82bb-820da06129fa.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mucus Relief Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | b1ba8ade-3441-f243-e053-2995a90a1230 | 2024-10-21 | Warnings | M012 |
| Mucus Relief Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | b1ba22ac-c38d-a42e-e053-2995a90a6900 | 2024-10-21 | Warnings | M012 |
| Diphenhydramine HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 25034563-6422-daf6-e063-6394a90af980 | 2024-10-21 | Warnings | M012 |
| Childrens Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER | 198add5f-20b7-75b0-e063-6394a90a6bd4 | 2024-10-21 | Warnings | M012 |
| Tukol Honey Children Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | dae33df8-2294-4242-a25b-2d89d1f63b23 | 2024-10-18 | Warnings | M012 |
| sinus pressure and pain pe | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | a7931e4c-8a5e-66e2-e053-2995a90af2a4 | 2024-10-18 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GoodSense | 570ea130-6a99-446e-9f97-14fc95809006 | 2024-10-18 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | a14999e3-a9d9-0a1f-e053-2995a90af7b3 | 2024-10-18 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | a793000b-3ef9-5662-e053-2a95a90ad0da | 2024-10-18 | Warnings | M012 |
| Cold Multi-Symptom Daytime and Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | GoodSense | 37455f86-ab21-472b-9e80-40324699f3ca | 2024-10-18 | Warnings | M012 |
| Head Congestion Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | e3396a27-8643-71fa-e053-2a95a90a713d | 2024-10-18 | Warnings | M012 |
| Head Congestion Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | e3397f69-3267-ca0b-e053-2995a90a7db5 | 2024-10-18 | Warnings | M012 |
| Cold and Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GoodSense | 747512a2-3b6d-496b-ab80-819060314163 | 2024-10-18 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | AMERISOURCE BERGEN | 9daf7f40-d9c5-4367-be41-894208358fc1 | 2024-10-18 | Warnings | M012 |
| Cold Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 608e6808-29e4-40bc-8496-24c092681a1b | 2024-10-18 | Warnings | M012 |
| Cold Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 665db127-ee04-46c4-bff0-e0fe9950c3e2 | 2024-10-18 | Warnings | M012 |
| Cold Max Day and Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 87a1cc06-9994-4fa9-8c64-e2ffdd33a2f8 | 2024-10-18 | Warnings | M012 |
| Cold Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 604d7e53-4bfd-4cdd-aed2-b304ae82ce44 | 2024-10-18 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | DISCOUNT DRUG MART | 4d93a703-c905-4fb3-b772-11c207065d4d | 2024-10-17 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | 62c35320-87b5-46e2-9f6f-cb0882bdb52e | 2024-10-17 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58593-225-06 | 58593022506 | 178 mL in 1 BOTTLE (58593-225-06) | 178 ml | 2007-10-01 | 2026-10-31 | No | No | Current |