Gilphex
- Product NDC
- 58552-336
- 11-digit product format
- 585520336
- Labeler code
- 58552
- Product ID
- 58552-336_40b9f8d7-5f71-656f-e063-6294a90a3b8b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin, Phenylephrine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Gil Pharmaceutical Corp.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-05-05
- Substance
- GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 390; 10 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
- Gilphex
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 390 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ, 04JA59TNSJ |
| Rxcui | 2603663 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58552-336-01 | Gilphex | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 58552-336-02 | Gilphex | 2 in 1 BLISTER PACK | TABLET | 2 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58552-336 | GILPHEX (GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241027_e7c8fb97-02cf-4df6-b477-9ff69d6b675d.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 |
|---|
| 58552-336-01 | 58552033601 | 100 TABLET in 1 BOTTLE (58552-336-01) | 100 tablet | 2022-05-05 | 0000-00-00 | No | No | Current |
| 58552-336-02 | 58552033602 | 2 TABLET in 1 BLISTER PACK (58552-336-02) | 2 tablet | 2022-05-05 | 0000-00-00 | Yes | No | Current |