Giltuss Cough and Cold
- Product NDC
- 58552-331
- 11-digit product format
- 585520331
- Labeler code
- 58552
- Product ID
- 58552-331_40b98a8e-7695-b8d6-e063-6294a90af8ea
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Gil Pharmaceutical Corp
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-04-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 28; 388; 10 mg/1; mg/1; mg/1
- 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 | 28 mg/1 |
| GUAIFENESIN | 388 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 2167784 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58552-331-20 | Giltuss Cough and Cold | 2 in 1 CARTON | TABLET | 2 | | 7 |
| 58552-331-20 | Giltuss Cough and Cold | 10 in 1 BLISTER PACK | TABLET | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58552-331 | GILTUSS COUGH AND COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250315_8590fcc9-c0dd-f43b-e053-2991aa0a692e.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 |
|---|
| 58552-331-20 | 58552033120 | 2 BLISTER PACK in 1 CARTON (58552-331-20) / 10 TABLET in 1 BLISTER PACK | 2 blister pack | 2021-04-01 | 0000-00-00 | Yes | No | Current |