Giltuss D
- Product NDC
- 65852-010
- 11-digit product format
- 658520010
- Labeler code
- 65852
- Product ID
- 65852-010_3f17eefb-b626-b0f2-e063-6294a90afd4d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Giltuss D
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Dextrum Laboratories Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-11
- Substance
- CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 3.5; 10 mg/10mL; mg/10mL
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Giltuss D
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORPHENIRAMINE MALEATE | 3.5 mg/10mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V1Q0O9OJ9Z, 04JA59TNSJ |
| Rxcui | 2724415 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65852-010-04 | Giltuss D | 1 in 1 CARTON | SYRUP | 1 | | 1 |
| 65852-010-04 | Giltuss D | 118 mL in 1 BOTTLE, PLASTIC | SYRUP | 118 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 65852-010-04 | 65852001004 | 1 BOTTLE, PLASTIC in 1 CARTON (65852-010-04) / 118 mL in 1 BOTTLE, PLASTIC | 2024-04-11 | No | No | Historical |