Rompe Pecho CF
- Product NDC
- 58593-001
- 11-digit product format
- 585930001
- Labeler code
- 58593
- Product ID
- 58593-001_23f92979-e90b-8620-e063-6294a90a9790
- 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
- BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 4; 10 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rompe Pecho CF
- Brand name suffix
- CF
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BROMPHENIRAMINE MALEATE | 4 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IXA7C9ZN03, 9D2RTI9KYH |
| Rxcui | 2676758 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58593-001-06 | Rompe Pecho CFCF | 178 mL in 1 BOTTLE | LIQUID | 178 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58593-001 | ROMPE PECHO CF CF (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) LIQUID [EFFICIENT LABORATORIES INC] | 5 | Current NDC, 1 package rows | 20241010_06e96e0c-f21f-e706-e063-6294a90a0780.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58593-001-06 | 58593000106 | 178 mL in 1 BOTTLE (58593-001-06) | 178 ml | 2023-10-01 | No | No | Current |