Rompe Pecho
- Product NDC
- 58593-830
- 11-digit product format
- 585930830
- Labeler code
- 58593
- Product ID
- 58593-830_3013da13-64a9-4800-e063-6294a90a6efe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- EFFICIENT LABORATORIES INC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-09-01
- Marketing end
- 2026-11-30
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rompe Pecho
- Brand name suffix
- Nighttime
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ |
| Rxcui | 1431245 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58593-830-06 | Rompe PechoNighttime | 180 mL in 1 BOTTLE | LIQUID | 180 | | 10 |
| 58593-830-06 | Rompe PechoNighttime | 1 in 1 CARTON | LIQUID | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58593-830 | ROMPE PECHO NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250328_2ec319a8-92bf-4552-86dd-37cbce18980f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58593-830-06 | 58593083006 | 1 BOTTLE in 1 CARTON (58593-830-06) / 180 mL in 1 BOTTLE | 1 bottle | 2019-09-01 | 2026-11-30 | No | No | Current |