Limpia Pecho
- Product NDC
- 54859-011
- 11-digit product format
- 548590011
- Labeler code
- 54859
- Product ID
- 54859-011_47467f14-6d34-afd0-e063-6294a90a0f26
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Llorens Pharmaceutical International Division, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-05-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 10; 100 mg/5mL; mg/5mL
- Pharmacologic classes
- 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]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Limpia Pecho
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| GUAIFENESIN | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 996520 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54859-011-04 | Limpia Pecho | 118 mL in 1 BOTTLE | LIQUID | 118 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54859-011 | LIMPIA PECHO (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241222_cbaea3e4-4c4b-4ff9-ae6f-95b6a2d3faf3.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 |
|---|
| 54859-011-04 | 54859001104 | 118 mL in 1 BOTTLE (54859-011-04) | 118 ml | 2019-05-01 | 0000-00-00 | No | No | Current |