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 | 2026-10-15 | ||
| excluded package | package | 16030-201 | 16030-201-10 | I | Inactivated by FDA | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| Signature Care Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Better Living Brands LLC | 5d7228ce-f108-4cc2-9aec-8b4548c3a155 | 2023-12-20 | Warnings | M018 |
| Target Eye Drops Maximum Redness Relief Eye | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE | Target Corporation | 1b26cd3b-4a05-4623-b320-01f22b3106ff | 2023-12-20 | Warnings | M018 |
| Kroger High Performance Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Kroger | d2aa8963-1922-02f3-e053-2a95a90a7d93 | 2023-12-20 | Warnings | M018 |
| Kroger Eye Drops Seasonal Relief | TETRAHYDROZOLINE HCL, ZINC SULFATE | Kroger | f6829be4-e3b7-7ff2-e053-2995a90a80fc | 2023-12-20 | Warnings | M018 |
| Rite Aid Multi-Symptom Relief Eye Drops | POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE | Rite Aid Corporation | efa7d208-9d42-13c7-e053-2a95a90a11b3 | 2023-12-20 | Warnings | M018 |
| Signature Care Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Better Living Brands LLC | ea358e01-f03e-454b-bae1-6c83da44c369 | 2023-12-20 | Warnings | M018 |
| TopCare Health Original Eye Drops | TETRAHYDROZOLINE HCL | Topco Associates LLC | 9c61a56a-c1a9-2846-e053-2995a90a755b | 2023-12-20 | Warnings | M018 |
| Signature Care Eye Drops A.C. | TETRAHYDROZOLINE HCL, ZINC SULFATE | Better Living Brands LLC | f685aca4-93d0-26d9-e053-2995a90a6e51 | 2023-12-20 | Warnings | M018 |
| Kroger Lubricant Eye | CARBOXYMETHYLCELLULOSE SODIUM | The Kroger Co. | 046f4ebc-d8f9-4755-b6ba-790fe86f3128 | 2023-12-20 | Warnings | M018 |
| Kroger Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Kroger Company | f7ad77fc-d890-25b9-e053-6394a90a2b12 | 2023-12-20 | Warnings | M018 |
| TopCare Health Dry Eye Relief Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Topco Associates LLC | 9c617e34-fc66-1a5b-e053-2995a90ace2c | 2023-12-20 | Warnings | M018 |
| Equaline Advanced Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | United Natural Foods, Inc. | f7602789-179a-edfc-e053-6294a90a0844 | 2023-12-20 | Warnings | M018 |
| Topcare Health Ultra Itch Relief Astringent Eye Drops | TETRAHYDROZOLINE HCL, ZINC SULFATE | Topco Associates LLC | 9c617e34-fc64-1a5b-e053-2995a90ace2c | 2023-12-20 | Warnings | M018 |
| Topcare Health Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | Topco Associates LLC | 9c614c0e-5862-682f-e053-2a95a90abc09 | 2023-12-20 | Warnings | M018 |
| Topcare Health Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Topco Assoc LLC | 9c6284f9-00bb-37b5-e053-2a95a90ae2ee | 2023-12-20 | Warnings | M018 |
| HEB Dry Eye Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | HEB | f80023cf-8e42-780a-e053-6294a90a66cd | 2023-12-20 | Warnings | M018 |
| TopCare Health Advanced Moisturizing Plus Redness Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Topco Associates LLC | 9c6193a6-d822-1b27-e053-2995a90ab3cf | 2023-12-20 | Warnings | M018 |
| Topcare Maximum Redness Relief Eye Drops | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE | Topco Assoc LLC | 9c6193a6-d824-1b27-e053-2995a90ab3cf | 2023-12-20 | Warnings | M018 |
| HEB Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | HEB | 5d522e4d-d647-486f-a947-25c14b1417fa | 2023-12-20 | Warnings | M018 |
| HEB A.C. Eye Drops | TETRAHYDROZOLINE HCL, ZINC SULFATE | HEB Grocery Company., LP | f680a8c1-dc91-7a52-e053-2a95a90a571e | 2023-12-20 | 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 |