Rompe Pecho SF Flu
- Product NDC
- 58593-002
- 11-digit product format
- 585930002
- Labeler code
- 58593
- Product ID
- 58593-002_23eb017d-6da7-5f0a-e063-6294a90a78c0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Brompheniramine Maleate, Dextromethorphan HBr
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Efficient Laboratories Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; BROMPHENIRAMINE MALEATE
- Active strength
- 10; 4 mg/5mL; mg/5mL
- Pharmacologic classes
- 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
- 2027-12-31
- 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 SF Flu
- Brand name suffix
- SF Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| BROMPHENIRAMINE MALEATE | 4 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| IXA7C9ZN03 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2676758 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 06eac696-e8f6-ac50-e063-6394a90a2ed6 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58593-002-06 | Rompe Pecho SF FluSF Flu | 178 mL in 1 BOTTLE | LIQUID | 178 | 6 |
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 |
|---|---|---|---|---|---|---|
| careone tussin dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | American Sales Company | 6c90fccf-0e6f-43df-9468-d8ece8ded009 | 2024-11-11 | Warnings | M012 |
| good sense night time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 89dc1423-d097-47a8-9025-eab5381cca26 | 2024-11-11 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 10f9627b-edda-422a-b01f-7066f9c98335 | 2024-11-11 | Warnings | M012 |
| nighttime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 17c3fe42-3c40-4405-80b7-b3f9e4aa8376 | 2024-11-11 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | H E B | 1dd36aa7-f085-4350-8cf2-f9fa29b583e4 | 2024-11-11 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | a7f9f1d0-7498-461c-b4e8-4c92cf3feae8 | 2024-11-11 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Walgreen Company | bd079f5d-0a38-40e6-9661-e8236c88a24d | 2024-11-11 | Warnings | M012 |
| GUAIFENESIN DM | GUAIFENESIN AND DEXTROMETHORPHAN | PAI Holdings, LLC dba PAI Pharma | ff970fff-d1a3-4322-83b4-34e361431a1c | 2024-11-11 | Warnings | M012 |
| topcare tussin dm max | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | e1118592-30ac-4505-9f38-c6d395c4cf5b | 2024-11-11 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 624b8029-9fdb-4908-a13b-f9dd75030120 | 2024-11-11 | Warnings | M012 |
| Biofreeze Colorless | MENTHOL | A-S Medication Solutions | cc1cba14-da40-4d7d-b522-b5c648798e96 | 2024-11-11 | Warnings | M012 |
| foster and thrive nighttime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 298b7754-d0d8-496d-9949-4c346cb11e34 | 2024-11-11 | Warnings | M012 |
| leader tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Cardinal Health 110, LLC. dba Leader | b418c10c-528b-4395-944e-af959b639ec2 | 2024-11-10 | Warnings | M012 |
| equaline adult tussin | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | United Natural Foods, Inc. dba UNFI | f7c753f8-4b12-4797-a599-736d597bc1bc | 2024-11-10 | Warnings | M012 |
| foster and thrive adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Strategic Sourcing Services LLC | f8933226-fbc9-44e3-a90f-4e6c1dbdb7b7 | 2024-11-10 | Warnings | M012 |
| dg health adult tussin | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dolgencorp Inc | 81f12484-ddf7-49c6-b530-3a81d62ab40d | 2024-11-10 | Warnings | M012 |
| careone tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Retail Business Services, LLC | 230fa1ea-ae7c-425e-8447-79a90c96ae9e | 2024-11-10 | Warnings | M012 |
| good sense tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | L. Perrigo Company | cb8a1d81-b1a3-4217-b157-9e5d398f202d | 2024-11-09 | Warnings | M012 |
| PhysiciansCare Allergy Antihistamine | DIPHENHYDRAMINE HYDROCHLORIDE | Acme United Corporation | 5e31b1ff-291f-7b8c-e053-2a91aa0aedbc | 2024-11-09 | Warnings | M012 |
| Duraflu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | 55fffc1d-8449-4c28-a391-c6f60dd85622 | 2024-11-09 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2676758 | brompheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG in 5 mL Oral Solution | PSN | 06eac696-e8f6-ac50-e063-6394a90a2ed6 | 6 |
| 2676758 | brompheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 2 MG/ML Oral Solution | SCD | 06eac696-e8f6-ac50-e063-6394a90a2ed6 | 6 |
| 2676758 | brompheniramine maleate 4 MG / dextromethorphan hydrobromide 10 MG per 5 ML Oral Solution | SY | 06eac696-e8f6-ac50-e063-6394a90a2ed6 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58593-002-06 | 58593000206 | 178 mL in 1 BOTTLE (58593-002-06) | 178 ml | 2023-10-01 | No | No | Current |