Phenylephrine Hydrochloride
- Product NDC
- 50090-4514
- 11-digit product format
- 500904514
- Labeler code
- 50090
- Product ID
- 50090-4514_ac27706a-feef-47ba-b3e8-d95b3303c1e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenylephrine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- A-S Medication Solutions
- Application
- NDA207926
- Marketing category
- NDA
- Marketing start
- 2015-01-15
- Marketing end
- 0000-00-00
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 25 mg/mL
- Pharmacologic classes
- alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4514-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1685-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP. PHENYLEPHRINE HYDROCHLORIDE ophthalmic solution, USP 2.5% and 10%. Initial U.S. Approval: 1939 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4514-0 | Phenylephrine Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 7 | |
| 50090-4514-0 | Phenylephrine Hydrochloride | 2 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-4514-0 | ML - Milliliter | 50090-4514 | 41bf601e-f178-460b-af22-091f33680028 | 1 | 2022-07-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4514 | PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] | 7 | Legacy NDC, 2 package rows | 20210417_9cfafc70-6218-4de6-9351-cb08e6350e84.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234579 | phenylephrine HCl 2.5 % Ophthalmic Solution | PSN | 9cfafc70-6218-4de6-9351-cb08e6350e84 | 7 |
| 1234579 | phenylephrine hydrochloride 25 MG/ML Ophthalmic Solution | SCD | 9cfafc70-6218-4de6-9351-cb08e6350e84 | 7 |
| 1234579 | phenylephrine hydrochloride 2.5 % Ophthalmic Solution | SY | 9cfafc70-6218-4de6-9351-cb08e6350e84 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-4514-0 | 50090451400 | 1 BOTTLE, DROPPER in 1 CARTON (50090-4514-0) > 2 mL in 1 BOTTLE, DROPPER | 2019-09-10 | 0000-00-00 | No | No | Current |