Giltuss TR
- Product NDC
- 58552-335
- 11-digit product format
- 585520335
- Labeler code
- 58552
- Product ID
- 58552-335_40b9f633-6072-fe3a-e063-6394a90afb8d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin,Dextromethorphan HBr,Phenylephrine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Gil Pharmaceutical Corp
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-01-07
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 29; 390; 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 TR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 29 mg/1 |
| GUAIFENESIN | 390 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 2603662 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58552-335-01 | Giltuss TR | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 58552-335-02 | Giltuss TR | 2 in 1 BLISTER PACK | TABLET | 2 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58552-335 | GILTUSS TR (GUAIFENESIN,DEXTROMETHORPHAN HBR,PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241027_6cfefcd3-110a-4381-91cf-0f71407ac78e.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 |
|---|
| 58552-335-01 | 58552033501 | 100 TABLET in 1 BOTTLE (58552-335-01) | 100 tablet | 2022-01-07 | 0000-00-00 | No | No | Current |
| 58552-335-02 | 58552033502 | 2 TABLET in 1 BLISTER PACK (58552-335-02) | 2 tablet | 2022-01-07 | 0000-00-00 | Yes | No | Current |