Phenylephrine Hydrochloride
- Product NDC
- 57631-018
- 11-digit product format
- 576310018
- Labeler code
- 57631
- Product ID
- 57631-018_4024f888-60d7-f820-e063-6394a90ab81d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Phenylephrine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- InvaTech Pharma Solutions LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-01-13
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [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
- Phenylephrine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04JA59TNSJ |
| Rxcui | 1049182 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57631-018-00 | Phenylephrine Hydrochloride | 30000 in 1 DRUM | TABLET | 30000 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57631-018-00 | 57631001800 | 30000 TABLET in 1 DRUM (57631-018-00) | 30000 tablet | 2021-01-13 | No | No | Current |