PHENAGIL
- Product NDC
- 58552-337
- 11-digit product format
- 585520337
- Labeler code
- 58552
- Product ID
- 58552-337_40babb39-ba9f-f7b6-e063-6394a90a3ab6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Gil Pharmaceutical Corp.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-05-26
- Substance
- CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 3.5; 29; 10 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
- PHENAGIL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORPHENIRAMINE MALEATE | 3.5 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 29 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V1Q0O9OJ9Z, 9D2RTI9KYH, 04JA59TNSJ |
| Rxcui | 2603661 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58552-337-01 | PHENAGIL | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 58552-337-02 | PHENAGIL | 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 |
|---|
| 58552-337 | PHENAGIL (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241027_a6880389-0dc1-43a7-a73b-77f77bafe51e.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 |
|---|
| 58552-337-01 | 58552033701 | 100 TABLET in 1 BOTTLE (58552-337-01) | 100 tablet | 2022-05-26 | 0000-00-00 | No | No | Current |
| 58552-337-02 | 58552033702 | 2 TABLET in 1 BLISTER PACK (58552-337-02) | 2 tablet | 2022-05-26 | 0000-00-00 | Yes | No | Current |