REFRESH CLASSIC
- Product NDC
- 50090-2358
- 11-digit product format
- 500902358
- Labeler code
- 50090
- Product ID
- 50090-2358_2a6ae637-2f65-4a5f-99d3-e3560f67b8f0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Polyvinyl Alcohol, Povidone
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- A-S Medication Solutions
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1985-09-12
- Substance
- POLYVINYL ALCOHOL; POVIDONE
- Active strength
- 14; 6 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- REFRESH CLASSIC
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POLYVINYL ALCOHOL | 14 mg/mL |
| POVIDONE | 6 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 532B59J990 | Internal UNII lookup |
| FZ989GH94E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 359969 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3bf6193c-56db-45ad-844c-58eb8c33cba9 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-2358-1 | 2023-02-07 | C162847 | 48780-1 | f386c64a-03fc-0266-e053-dadaa90a7c1a | REFRESH CLASSIC |
| 50090-2358-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-03fc-0266-e053-dadaa90a7c1a | REFRESH CLASSIC |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-2358-1 | REFRESH CLASSIC | 30 in 1 CARTON | SOLUTION/ DROPS | 30 | 18 | |
| 50090-2358-1 | REFRESH CLASSIC | .4 mL in 1 VIAL, SINGLE-USE | SOLUTION/ DROPS | .4 | 18 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2358-1 | EA - Each | 50090-2358 | d52774bd-6c4e-4090-870a-10d4222167c4 | 1 | 2019-02-13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-2358 | REFRESH CLASSIC (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] | 18 | Current NDC, Legacy NDC, 2 package rows | 20240316_3bf6193c-56db-45ad-844c-58eb8c33cba9.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Visine Red Eye Total Comfort and Tears Dry Eye Relief | TETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATE | Kenvue Brands LLC | 0bc0d6e7-9195-db6b-e063-6294a90aef04 | 2024-11-14 | Warnings | M018 |
| Visine Red Eye Comfort | TETRAHYDROZOLINE HYDROCHLORIDE | Kenvue Brands LLC | d7abd7cb-e094-481f-bea5-a5983e2c9ef4 | 2024-11-13 | Warnings | M018 |
| Visine Red Eye Hydrating Comfort Eye Drops | TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 | Kenvue Brands LLC | a9a90de6-3172-4d34-984b-f4442f880e3d | 2024-11-13 | Warnings | M018 |
| Visine Dry Eye Relief | POLYETHYLENE GLYCOL 400 | Kenvue Brands LLC | 2de7a41d-661d-495f-89b4-5690664a3a3d | 2024-11-13 | Warnings | M018 |
| Visine Dry Eye Relief Eye Drops | POLYETHYLENE GLYCOL 400 | Kenvue Brands LLC | d9d3f000-3ce4-4ba2-a7fb-491b44eb3fa1 | 2024-11-13 | Warnings | M018 |
| Visine Dry Eye Relief | POLYETHYLENE GLYCOL 400 | Kenvue Brands LLC | a4c57620-778f-4434-9105-ead2f85c5884 | 2024-11-13 | Warnings | M018 |
| Visine A.C. Itchy Eye Relief | TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORM | Kenvue Brands LLC | 257b9666-0163-499b-9673-bf6f4d6899b1 | 2024-11-13 | Warnings | M018 |
| Eyewash Station Additive Concentrate | CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL | Acme United Corporation | f19fbe28-b928-7c6e-e053-2995a90a43cb | 2024-11-09 | Warnings | M018 |
| RUGBY EYE WASH | WATER, PURIFIED | A-S Medication Solutions | 0773e558-2f46-494c-888a-3bc517202b65 | 2024-11-08 | Warnings | M018 |
| Clear Eyes Triple Relief | POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE | Prestige Brands Holdings, Inc. | 1269a1a6-843d-4d08-bb3c-c1f3d2e7080d | 2024-10-25 | Warnings | M018 |
| EyS Eye Wash | WATER | Eyes-Plus LLC | 1443f6bf-3a77-4a19-8585-0ec58efe042f | 2024-10-15 | Warnings | M018 |
| Eye Wash | WATER SOLUTION | Kroger Company | 354402ad-581d-47e7-9fd3-933bef281ff4 | 2024-10-11 | Warnings | M018 |
| Eye Wash | WATER | Hubei Changjian Medical Products Co., Ltd. | d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea | 2024-10-11 | Warnings | M018 |
| Capasil Pain Relieving | MENTHOL, METHYL SALICYLATE | PureTek Corporation | b1a8e78c-57f0-1f3e-e053-2995a90acbd5 | 2024-10-01 | Warnings | M018 |
| Mencylate Pain Relieving | MENTHOL, METHYL SALICYLATE | PureTek Corporation | f824de86-9492-2e6b-e053-6294a90a6f2a | 2024-10-01 | Warnings | M018 |
| Advanced Eye Relief/ Redness Maximum Relief | NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE | Bausch & Lomb Incorporated | 3c11285a-7e86-4b47-b1ee-e7d59858087d | 2024-09-25 | Warnings | M018 |
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | cc3d5bc8-9d3c-4c65-9e43-707a2db4081a | 2024-09-25 | Warnings | M018 |
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | 93fafa27-5031-4d95-b4b8-5574b7204ae2 | 2024-09-25 | Warnings | M018 |
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | 454f337e-d897-46de-ab05-1c543a33061c | 2024-09-25 | Warnings | M018 |
| PURPOSE | OCTINOXATE, OCTISALATE AND OXYBENZONE | Bausch & Lomb Incorporated | a1e14135-b8da-4cee-8c5b-1893572f4de4 | 2024-09-25 | Warnings | M018 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 359969 | polyvinyl alcohol 1.4 % / povidone 0.6 % Ophthalmic Solution | PSN | 3bf6193c-56db-45ad-844c-58eb8c33cba9 | 18 |
| 359969 | polyvinyl alcohol 0.014 ML/ML / povidone 6 MG/ML Ophthalmic Solution | SCD | 3bf6193c-56db-45ad-844c-58eb8c33cba9 | 18 |
| 359969 | polyvinyl alcohol 1.4 % / povidone 0.6 % Ophthalmic Solution | SY | 3bf6193c-56db-45ad-844c-58eb8c33cba9 | 18 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-2358-1 | 50090235801 | 30 VIAL, SINGLE-USE in 1 CARTON (50090-2358-1) / .4 mL in 1 VIAL, SINGLE-USE | 2016-04-21 | 0000-00-00 | No | No | Current |