Giltuss Cough and Cold
- Product NDC
- 58552-130
- 11-digit product format
- 585520130
- Labeler code
- 58552
- Product ID
- 58552-130_40b83027-94f0-8f48-e063-6294a90ad555
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Gil Pharmaceutical Corp
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-10-02
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 15; 300; 10 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Giltuss Cough and Cold
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/5mL |
| GUAIFENESIN | 300 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1251031 |
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 |
|---|
| 58552-130-04 | Giltuss Cough and Cold | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 6 |
| 58552-130-04 | Giltuss Cough and Cold | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58552-130 | GILTUSS COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [GIL PHARMACEUTICAL CORP] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241027_8503c956-42a5-7684-e053-2991aa0adb27.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 |
|---|
| 58552-130-04 | 58552013004 | 1 BOTTLE in 1 CARTON (58552-130-04) / 118 mL in 1 BOTTLE | 1 bottle | 2018-10-02 | 0000-00-00 | No | No | Current |