Phenylephrine Hydrochloride
- Product NDC
- 0065-0343
- 11-digit product format
- 000650343
- Labeler code
- 0065
- Product ID
- 0065-0343_c9ffa382-0391-4947-9638-dd7d648a6e38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenylephrine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alcon Laboratories, Inc.
- Application
- NDA207926
- Marketing category
- NDA
- Marketing start
- 2015-01-15
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 100 mg/mL
- 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 | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04JA59TNSJ |
| Rxcui | 1234571, 1234579 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0065-0343-02 | Phenylephrine Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
| 0065-0343-02 | Phenylephrine Hydrochloride | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0065-0343 | PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 3 | Current NDC, 2 package rows | 20250403_cacbb3fd-1c03-4523-a1bf-0ccc4be102ef.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0065-0343-02 | 00065034302 | 1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02) / 5 mL in 1 BOTTLE, DROPPER | 2025-04-30 | No | No | Historical |