Polyvinyl Alcohol Eye Drops 1,4 % w/v
- Product NDC
- 16030-201
- 11-digit product format
- 160300201
- Labeler code
- 16030
- Product ID
- 16030-201_47edd91f-7907-3a97-e063-6294a90ad9df
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Polyvinyl Alcohol Eye Drops 1,4 % w/v
- Dosage form
- FOR SOLUTION
- Route
- TOPICAL
- Labeler
- Aurolab
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-09-20
- Substance
- POLYVINYL ALCOHOL, UNSPECIFIED
- Active strength
- 5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 16030-201 | I | Inactivated by FDA | 2026-10-12 | ||
| excluded package | package | 16030-201 | 16030-201-10 | I | Inactivated by FDA | 2026-10-12 |
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
- Polyvinyl Alcohol Eye Drops 1,4 % w/v
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POLYVINYL ALCOHOL, UNSPECIFIED | 5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 532B59J990 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e8e09719-6e06-612b-e053-2995a90a79fc | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16030-201-05 | Polyvinyl Alcohol Eye Drops 1,4 % w/v | 5 mL in 1 BOTTLE, DROPPER | FOR SOLUTION | 5 | 9 | |
| 16030-201-10 | Polyvinyl Alcohol Eye Drops 1,4 % w/v | 10 mL in 1 BOTTLE, DROPPER | FOR SOLUTION | 10 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 16030-201 | POLYVINYL ALCOHOL EYE DROPS 1,4 % W/V FOR SOLUTION [AUROLAB] | 8 | Current NDC, Legacy NDC, 1 package rows | 20241224_e8e09719-6e06-612b-e053-2995a90a79fc.zip |
| 16030-201 | POLYVINYL ALCOHOL EYE DROPS 1,4 % W/V FOR SOLUTION [AUROLAB] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241224_ec5cf186-f141-4377-e053-2995a90a6b32.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 |
|---|---|---|---|---|---|---|
| Medics Choice Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | K.C. Pharmaceuticals, Inc. | 9ddfc275-602f-413b-e053-2995a90a11cb | 2025-12-30 | Warnings | M018 |
| Medics Choice Eye Drops Seasonal Relief | TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE | KC Pharmaceuticals, Inc. | 92bd8cb4-90ad-4a47-afa4-30d1fa658d62 | 2025-12-30 | Warnings | M018 |
| DG Health Advanced Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Dolgencorp LLC | 9c62f8a3-7cf5-40f9-e053-2a95a90afd86 | 2025-12-30 | Warnings | M018 |
| Medics Choice Eye Drops Original Redness Reliever | TETRAHYDROZOLINE HYDROCHLORIDE | KC Pharmaceuticals, Inc. | e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be | 2025-12-30 | Warnings | M018 |
| Medics Choice Eye Drops Maximum Redness Relief | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE | K.C. Pharmaceuticals, Inc. | f7131707-47af-d70a-e053-6394a90a418f | 2025-12-30 | Warnings | M018 |
| DG Original Eye Drops | TETRAHYDROZOLINE HCL | Dolgencorp LLC | 9cb2123c-3ed4-ce8f-e053-2995a90a0ab8 | 2025-12-30 | Warnings | M018 |
| Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | KC Pharmaceuticals, Inc. | eb6eb6c4-1609-407b-84e4-c7509811f3c0 | 2025-12-30 | Warnings | M018 |
| Medics Choice Eye Drops Advanced | TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE | KC Pharmaceuticals, Inc. | ab906fd8-265c-4359-a920-d626366e245c | 2025-12-30 | Warnings | M018 |
| Medics Choice Fresh and Soothe Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | KC Pharmaceuticals, Inc. | 1f65b91a-4eac-65c2-e063-6394a90a0295 | 2025-12-30 | Warnings | M018 |
| DG Health Dry Eye Relief | GLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400 | Dolgencorp LLC | 9cb20c3b-bf6d-8c7c-e053-2995a90aa485 | 2025-12-30 | Warnings | M018 |
| DG Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Dolgencorp LLC | 9cb27899-6c36-3c37-e053-2995a90a1d43 | 2025-12-30 | Warnings | M018 |
| Publix Artificial Tears Eye Drops | POLYVINYL ALCOHOL, POVIDONE | Publix Super Markets, Inc. | f5d1394b-0fe8-c372-e053-2a95a90a1f78 | 2025-12-30 | Warnings | M018 |
| Best Choice Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | Best Choice | f5ba63f3-7966-81fe-e053-2995a90a342c | 2025-12-30 | Warnings | M018 |
| DG Maximum Strength Redness Relief | GLYCERIN, NAPHAZOLINE HCL | Dolgencorp, Inc | 9cb261ed-b708-1189-e053-2a95a90a547d | 2025-12-30 | Warnings | M018 |
| Publix Advanced Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Publix Super Markets, Inc. | f7b0c3d6-0324-46c3-e053-6394a90a8241 | 2025-12-30 | Warnings | M018 |
| Publix Moisturizing Relief Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Publix Super Markets, Inc. | 9b391400-c53b-7c7b-e053-2995a90a2731 | 2025-12-30 | Warnings | M018 |
| Publix High Performance Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Publix Super Markets, Inc. | 9b402aa8-87cb-3928-e053-2995a90afa3c | 2025-12-30 | Warnings | M018 |
| Kroger Eye Drops Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | The Kroger Company | f76f08c5-0111-8bc5-e053-6294a90a16ee | 2025-12-30 | Warnings | M018 |
| Health Mart Lubricating Tears | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Strategic Sourcing Services LLC | c8be678f-2b4a-4d39-9cb4-910d36d72174 | 2025-12-30 | Warnings | M018 |
| Winco Maximum Redness Relief Eye Drops | GLYCERIN, NAPHAZOLINE HCL | WinCo Foods, LLC | ff3651d4-42ce-4db1-a318-15f7592baf86 | 2025-12-30 | Warnings | M018 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16030-201-05 | 16030020105 | 5 mL in 1 BOTTLE, DROPPER (16030-201-05) | 5 ml | 2025-12-01 | 0000-00-00 | No | No | Current |
| 16030-201-10 | 16030020110 | 10 mL in 1 BOTTLE, DROPPER (16030-201-10) | 10 ml | 2022-09-20 | 0000-00-00 | No | No | Current |