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 |
|---|---|---|---|---|---|---|
| Winco Original Formula Eye Drops | TETRAHYDROZOLINE HCL | WinCo Foods, LLC | 44266952-4054-4c12-b3fc-d0543fe54fe2 | 2025-12-30 | Warnings | M018 |
| Winco Irritation Relief Eye | TETRAHYDROZOLINE HCL, ZINC SULFATE | WinCo Foods, LLC | 60565184-5745-43a5-92b2-ab45b27e8bc6 | 2025-12-30 | Warnings | M018 |
| Core Values Eye Drops Dry Eye Relief | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Liberty Procurement Co. Inc. | f8285f68-c40c-19a8-e053-6394a90aacad | 2025-12-30 | Warnings | M018 |
| Core Values Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Liberty Procurement Co., Inc. | f76dfeca-4e86-0b5d-e053-6294a90a29b9 | 2025-12-30 | Warnings | M018 |
| Best Choice Eye Drops A.C. | TETRAHYDROZOLINE HCL, ZINC SULFATE | Best Choice (Valu Merchandisers Company) | f5e665e4-ebd7-8c35-e053-2995a90a8811 | 2025-12-30 | Warnings | M018 |
| Harris Teeter Eye Drops Artificial Tears | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Harris Teeter, LLC. | f82957d9-c4ad-a914-e053-6294a90aac50 | 2025-12-30 | Warnings | M018 |
| Best Choice Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Valu Merchandisers, Co. | f7491a17-8035-5a3c-e053-6294a90a615c | 2025-12-30 | Warnings | M018 |
| Winco Advanced Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | WinCo Foods, LLC | f10778c8-14fe-4852-8b73-42db502fd2bc | 2025-12-30 | Warnings | M018 |
| Harris Teeter Eye Drops Maximum Redness Relief | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE | Harris Teeter, LLC | f710d107-0403-21c5-e053-6394a90a0372 | 2025-12-30 | Warnings | M018 |
| CVS Astringent Eye | TETRAHYDROZOLINE HCL, ZINC SULFATE | CVS Pharmacy, Inc. | 07e1a56b-fdad-408d-bf5a-7a0144ece131 | 2025-12-30 | Warnings | M018 |
| Harris Teeter Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Harris Teeter, LLC | f76e2831-5c6c-7a62-e053-6294a90a937b | 2025-12-30 | Warnings | M018 |
| CVS Gentle Tears | DEXTRAN 70, HYPROMELLOSE | CVS Pharmacy, Inc. | 9b1ea0eb-c34f-6603-e053-2995a90a6a95 | 2025-12-30 | Warnings | M018 |
| CVS Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | CVS Pharmacy, Inc. | 8eef499d-c60e-9468-e053-2995a90a8714 | 2025-12-30 | Warnings | M018 |
| Foster and Thrive Lubricating Tears Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Strategic Sourcing Services LLC | 0042337b-c22a-157a-e063-6394a90a202e | 2025-12-30 | Warnings | M018 |
| CVS Lubricant Eye Drops Original | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | CVS | bb1ad35a-79ea-639f-e053-2995a90a96f3 | 2025-12-30 | Warnings | M018 |
| Foster and Thrive Advanced Relief Eye Drops | POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL | Strategic Sourcing Services LLC | 0019cd99-b245-2ffc-e063-6294a90a9f27 | 2025-12-30 | Warnings | M018 |
| CVS Multi-Symptom Eye Drops | POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE | CVS Pharmacy, Inc. | be3d7855-cc66-ace8-e053-2a95a90ab8f4 | 2025-12-30 | Warnings | M018 |
| Foster and Thrive Dry Eye Relief | POLYETHYLENE GLYCOL 400 | Strategic Sourcing Services LLC | 0018ade9-5856-db6c-e063-6394a90a2ccf | 2025-12-30 | Warnings | M018 |
| CareOne Itchy Relief Eye Drops 15mL | TETRAHYDROZOLINE HCI, ZINC SULFATE | Retail Business Services, LLC. | 997f16ff-2632-2e9d-e053-2995a90a6f51 | 2025-12-30 | Warnings | M018 |
| Foster and Thrive Redness Relief Eye Drops | GLYCERIN, NAPHAZOLINE HCL | Strategic Sourcing Services LLC | 0042e9a0-9693-d7e0-e063-6294a90ae6c6 | 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 |