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 |
|---|---|---|---|---|---|---|
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | AvPAK | b479d2ae-4b59-916a-e053-2995a90af8ec | 2025-11-11 | Warnings | M018 |
| Sodium Chloride | SODIUM CHLORIDE | Rising Pharma Holdings, Inc. | 42870188-b1d7-4934-a6c0-310530497dac | 2025-11-07 | Warnings | M018 |
| Systane Complete PF | PROPYLENE GLYCOL EMULSION | Alcon Laboratories, Inc. | 798ffdde-1dba-4a3f-a0b6-937f9e958cca | 2025-11-03 | Warnings | M018 |
| LACRIFRESH HYDRAPF | GLYCERIN, POVIDONE | AVIZOR, S.A. | 41bbd23e-0ec8-eb18-e063-6294a90a46d1 | 2025-10-27 | Warnings | M018 |
| LACRIFRESH HYDRAMAXPF | GLYCERIN, POVIDONE | AVIZOR, S.A. | 41be1604-89b4-7ec3-e063-6294a90a3331 | 2025-10-27 | Warnings | M018 |
| Up and Up Dry Eye Relief Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Target Corporation | 3b1834e6-75cf-5380-e063-6294a90ad1d5 | 2025-10-25 | Warnings | M018 |
| Up and Up Dry Eye Relief Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Hanlim | 420274c6-7bf0-0920-e063-6294a90a30be | 2025-10-25 | Warnings | M018 |
| Stye | POLYVINYL ALCOHOL AND POVIDONE | Medtech Products Inc. | 60c11d3d-df20-4d1c-b425-49a84fecea30 | 2025-10-23 | Warnings | M018 |
| TheraTears Lubricant | CARBOXYMETHYLCELLULOSE SODIUM | MEDTECH PRODUCTS INC | 797b0394-2f0f-4733-8d20-ec5bdf3e085d | 2025-10-23 | Warnings | M018 |
| Advanced Eye Relief Dry Eye Rejuvenation | GLYCERIN PROPYLENE GLYCOL | Bausch & Lomb Incorporated | 027969ee-64e4-4b08-bab7-c4cc8ed22f5f | 2025-10-23 | Warnings | M018 |
| TheraTears Lubricant | CARBOXYMETHYLCELLULOSE SODIUM | MEDTECH PRODUCTS INC | 661d8764-8ae6-4229-9485-867553ee8e16 | 2025-10-23 | Warnings | M018 |
| Refresh Relieva Preservative Free | CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN | Allergan, Inc. | 3481f9b3-5a90-40d3-80f8-81f51cc864be | 2025-10-22 | Warnings | M018 |
| Sodium Chloride Normal Salt | SODIUM CHLORIDE | Method Pharmaceuticals | ce84727a-3677-4bf0-e053-2995a90a3ec8 | 2025-10-21 | Warnings | M018 |
| iVIZIA Dry Eye | POVIDONE | Thea Pharma Inc. | 1ef73cb1-da48-a713-e063-6294a90afa9d | 2025-10-20 | Warnings | M018 |
| Walgreens Ultra Lubricant | POLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOL | Walgreens | 21dfe061-4533-2061-e063-6394a90a6e73 | 2025-10-17 | Warnings | M018 |
| Walgreens | SODIUM CHLORIDE | Walgreen Company | 21dfc2cf-65ae-c3fb-e063-6294a90a0a94 | 2025-10-17 | M018 | |
| Xpect Industrial Eye Relief | GLYCERIN, NAPHAZOLINE HCL | Cintas Corporation | a0167d06-7adb-36f4-e053-2a95a90af9ef | 2025-09-30 | Warnings | M018 |
| Xpect Eyewash | EYEWASH | Cintas Corporation | 1d69365d-662b-4248-8fa9-1629451b549a | 2025-09-30 | Warnings | M018 |
| REFRESH OPTIVE Drops | CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN | Allergan, Inc. | 80275190-d717-40ea-905b-5c8fbe986eac | 2025-09-15 | Warnings | M018 |
| Refresh Relieva PF Xtra | CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN | Allergan, Inc. | b51b8a75-8faa-430f-8f7e-ee58d3d13f2e | 2025-09-15 | 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 |