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 |
|---|---|---|---|---|---|---|
| CareOne Maximum Redness Relief Eye Drops | GLYCERIN, NAPHAZOLINE HCI | Retail Business Services, LLC | 9ab96aed-21d3-11b6-e053-2995a90a7225 | 2025-12-30 | Warnings | M018 |
| CVS Lubricant Eye Drops 30 ct | CARBOXYMETHYLCELLULOSE SODUIM | CVS Pharmacy, Inc. | 8dbca077-c989-767a-e053-2995a90a7cf5 | 2025-12-30 | Warnings | M018 |
| Foster and Thrive Original Formula Eye Drops | TETRAHYDROZOLINE HCL | Strategic Sourcing Services LLC | 002da62b-aec6-8e2a-e063-6294a90a5efc | 2025-12-30 | Warnings | M018 |
| CareOne Artificial Tears Eye Drops 15mL | POLYVINYL ALCOHOL, POVIDONE | Retail Business Services, LLC | 92fded6b-91fd-d82e-e053-2a95a90ab523 | 2025-12-30 | Warnings | M018 |
| Foster and Thrive Long Lasting Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Strategic Sourcing Services LLC | 00546df0-17d8-0e3c-e063-6294a90ae7b2 | 2025-12-30 | Warnings | M018 |
| Meijer Multi-Symptom Relief | POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE | Meijer, Inc. | e7a5677a-ff33-c039-e053-2a95a90ae6c7 | 2025-12-30 | Warnings | M018 |
| TopCare Health Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Topcare Associates LLC | e8e9dfe5-3540-a4df-e053-2a95a90aaf98 | 2025-12-30 | Warnings | M018 |
| Meijer Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Meijer Distribution, Inc. | b245f99f-785a-efdc-e053-2995a90a4911 | 2025-12-30 | Warnings | M018 |
| Equate Original Eye Drops | TETRAHYDROZOLINE HCL | Walmart, Inc. | eb8e5beb-4454-58c2-e053-2a95a90a66e0 | 2025-12-30 | Warnings | M018 |
| Avenova Lubricant Eye Drops High Performance | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | NovaBay Pharmaceuticals, Inc. | cd17f037-5aa5-0ef8-e053-2a95a90a39cb | 2025-12-30 | Warnings | M018 |
| Equate Redness and Dry Eye Relief Eye Drops | GLYCERIN, NAPHAZOLINE HCL | Wal-Mart Stores, Inc. | ae228018-9238-2cbd-e053-2995a90a8d99 | 2025-12-30 | Warnings | M018 |
| Equate Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Walmart, Inc. | deebaf7f-f20d-4d7f-e053-2a95a90a4b4f | 2025-12-30 | Warnings | M018 |
| Quality Choice Artificial Tears Lubricant Eye Drops | POLYVINYL ALCOHOL, POVIDONE | Chain Drug Marketing Association, Inc. | 1f669655-4bc7-0175-e063-6294a90a305a | 2025-12-30 | Warnings | M018 |
| Equate Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | Walmart, Inc. | ead9f271-0f15-1fff-e053-2a95a90a93ac | 2025-12-30 | Warnings | M018 |
| Equate Multi-Symptom Relief Eye Drops | POLYETHYLENE GLYCOL 400,TETRAHYDROZOLINE HCL, ZINC SULFATE | Walmart, Inc. | eb8ed76b-9cd7-3636-e053-2a95a90a9583 | 2025-12-30 | Warnings | M018 |
| CorneaCare Recover Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | CorneaCare Inc. | 1fd3a5ed-8963-5c8e-e063-6394a90a6527 | 2025-12-30 | Warnings | M018 |
| Eye Love Heyedrate Long Lasting Hydration | GLYCERIN, POVIDONE | Physician Recommended Neutraceuticals, L.P. | f321dea1-3251-eaa8-e053-2995a90aaf95 | 2025-12-30 | Warnings | M018 |
| Quality Choice Lubricant Eye Drops High Performance | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Chain Drug Marketing Assoc., Inc. | 0cd1b36a-a07a-a1db-e063-6294a90a5994 | 2025-12-30 | Warnings | M018 |
| Quality Choice Eye Drops Irritation Relief | TETRAHYDROZOLINE HCL, ZINC SULFATE | Quality Choice | 1f682079-6e91-e14b-e063-6394a90a3f12 | 2025-12-30 | Warnings | M018 |
| Quality Choice Moisturizing Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Chain Drug Marketing Association, Inc. | 1fb81759-5931-59c8-e063-6294a90a2277 | 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 |