Giltuss D
- Product NDC
- 58552-147
- 11-digit product format
- 585520147
- Labeler code
- 58552
- Product ID
- 58552-147_4aa0fa30-61e2-bdb5-e063-6394a90afffd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Giltuss D
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Gil Pharmaceutical Corp
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-11
- Substance
- CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 3.5; 10 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Giltuss D
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORPHENIRAMINE MALEATE | 3.5 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V1Q0O9OJ9Z, 04JA59TNSJ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58552-147-04 | Giltuss D | 1 in 1 CARTON | SYRUP | 1 | | 4 |
| 58552-147-04 | Giltuss D | 1 in 1 BOTTLE | SYRUP | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58552-147 | GILTUSS D SYRUP [GIL PHARMACEUTICAL CORP] | 2 | Current NDC, 2 package rows | 20241027_298f5457-a7df-474d-9854-68918ee3d330.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58552-147-04 | 58552014704 | 1 BOTTLE in 1 CARTON (58552-147-04) / 1 SYRUP in 1 BOTTLE | 1 bottle | 2024-04-11 | No | No | Current |