REFRESH OPTIVE Advanced
- Product NDC
- 0023-4307
- 11-digit product format
- 000234307
- Labeler code
- 0023
- Product ID
- 0023-4307_82284b10-2578-4490-bb19-e38da030a102
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- carboxymethylcellulose sodium, glycerin, and polysorbate 80
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Allergan, Inc.
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-11-30
- Substance
- CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN; POLYSORBATE 80
- Active strength
- 5; 10; 5 mg/mL; mg/mL; mg/mL
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 package | package | 0023-4307 | 0023-4307-03 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0023-4307 | 0023-4307-15 | D | Discontinued by firm | 2026-10-15 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0023-4307-03 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0023-4307-15 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0023-4307-15 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0023-4307-03 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0023-4307-15 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0023-4307-03 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0023-4307-15 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0023-4307-03 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0023-4307-15 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0023-4307-03 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0023-4307-15 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0023-4307-03 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0023-4307-15 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0023-4307-03 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0023-4307-15 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0023-4307-03 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0023-4307-15 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0023-4307-03 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0023-4307-02 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0023-4307-15 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0023-4307-03 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0023-4307-02 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0023-4307-15 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0023-4307-03 | 367a005e9d99… | 383a685ebd0f… |
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
- REFRESH OPTIVE Advanced
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM | 5 mg/mL |
| GLYCERIN | 10 mg/mL |
| POLYSORBATE 80 | 5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| K679OBS311 | Internal UNII lookup |
| PDC6A3C0OX | Internal UNII lookup |
| 6OZP39ZG8H | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1241471 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 08c722ec-780f-bb7b-8f14-3d4f7bf0e098 | Product name | 2 | 20240205 |
| e2f276e5-439f-b432-b5e5-b0cfa993da69 | Product name | 3 | 20220609 |
| 4585a4fb-0028-3d95-020c-9b1c40bf15e0 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0023-4307-02 | REFRESH OPTIVE Advanced | 2 mL in 1 BOTTLE | SOLUTION/ DROPS | 2 | 16 | |
| 0023-4307-02 | REFRESH OPTIVE Advanced | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 16 | |
| 0023-4307-03 | REFRESH OPTIVE Advanced | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 16 | |
| 0023-4307-03 | REFRESH OPTIVE Advanced | 3 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 3 | 16 | |
| 0023-4307-10 | REFRESH OPTIVE Advanced | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 16 | |
| 0023-4307-10 | REFRESH OPTIVE Advanced | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | 16 | |
| 0023-4307-15 | REFRESH OPTIVE Advanced | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | 16 | |
| 0023-4307-15 | REFRESH OPTIVE Advanced | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 16 | |
| 0023-4307-20 | REFRESH OPTIVE Advanced | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | 16 | |
| 0023-4307-20 | REFRESH OPTIVE Advanced | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0023-4307-10 | ML - Milliliter | 0023-4307 | 6beddd0f-1e0d-464e-8c0b-660f23fb644e | 1 | 2012-07-24 |
| 0023-4307-20 | ML - Milliliter | 0023-4307 | 0bf405a2-5414-49d3-9f27-81b625bae77c | 1 | 2013-04-01 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0023-4307 | REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.] | 15 | Current NDC, Legacy NDC, 10 package rows | 20241210_aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0.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 |
|---|---|---|---|---|---|---|
| Discount Drug Mart Redness Relief Eye Drops | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE | Discount Drug Mart, Inc. | 31a98e6c-42df-6b56-e063-6294a90a3564 | 2024-01-01 | Warnings | M018 |
| Harris Teeter Ultra Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Harris Teeter, LLC. | 31ac6883-ffc6-39de-e063-6294a90a52dd | 2024-01-01 | Warnings | M018 |
| Exchange Select High Performance Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Army and Air Force Exchange Service | 31ac8bd2-c2e9-6f2c-e063-6394a90adc72 | 2024-01-01 | Warnings | M018 |
| CVS Health Fast Acting Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | CVS Pharmacy, Inc. | 31addfd2-52f2-05b3-e063-6294a90a337f | 2024-01-01 | Warnings | M018 |
| Equate Eye Drops Dry Eye Relief | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Wal-Mart Stores, Inc. | 91fb8fb5-b871-4535-e053-2995a90a9b16 | 2023-12-23 | Warnings | M018 |
| Equate Lubricant Eye Drops Preservative-Free | CARBOXYMETHYLCELLULOSE SODIUM | Wal-Mart Stores, Inc. | 9228a39b-38d2-1dfc-e053-2a95a90a3c90 | 2023-12-23 | Warnings | M018 |
| Equate Restore Plus Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Walmart, Inc. | 9e665ca2-4fa6-fdb4-e053-2a95a90abcca | 2023-12-23 | Warnings | M018 |
| Sunmark Eye Drops Advanced Moisturizer/Lubricant | DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE | Strategic Sourcing Services LLC | 0daa4e39-0447-44b6-a7d7-370b12bf9451 | 2023-12-23 | Warnings | M018 |
| Equate Lubricant Eye Drops High Performance | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Wal-Mart Stores, Inc. | 91f85a72-5270-e4db-e053-2995a90aeb21 | 2023-12-23 | Warnings | M018 |
| Equate Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Wal-Mart Stores, Inc. | e32233ef-ea15-45b8-8e83-b658cf4c56a0 | 2023-12-23 | Warnings | M018 |
| Sunmark Eye Drops Original Formula | TETRAHYDROZOLINE HCL | Strategic Sourcing Services LLC | 33efa7e9-4c3a-4d72-af31-c5e35095c2ff | 2023-12-23 | Warnings | M018 |
| Sunmark Lubricant Eye Drops | POLYPROPYLENE GLYCOL 400, PROPYLENE GLYCOL | Strategic Sourcing Services LLC | b117ff0a-1a48-4022-96e6-52bc45f056fc | 2023-12-23 | Warnings | M018 |
| Sunmark Dry Eye Relief | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Strategic Sourcing Services LLC | 043ccc34-44ee-416a-88bc-f247774e9075 | 2023-12-23 | Warnings | M018 |
| Sunmark Lubricating Tears | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Strategic Sourcing Services LLC | 58f0b6d7-6072-40fd-ba72-b3ed68834791 | 2023-12-23 | Warnings | M018 |
| Leader Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Cardinal Health | 8d9a4eec-bf0e-6c3b-e053-2995a90ae9aa | 2023-12-23 | Warnings | M018 |
| Leader Eye Wash | PURIFIED WATER | Cardinal Health | 8d3ad11f-1945-f838-e053-2995a90a7aa5 | 2023-12-23 | Warnings | M018 |
| Good Neighbor Pharmacy Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Amerisource Bergen Drug Corp. | fd2dc23f-6ccc-2644-e053-6294a90a889e | 2023-12-23 | Warnings | M018 |
| Rite Aid Eye Drops Dry Eye Relief | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Rite Aid Corporation | fa1b5b66-9643-e9a7-e053-6394a90ae3cf | 2023-12-23 | Warnings | M018 |
| Signature Care Lubricant Eye Drops Long Lasting | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Better Living Brands, LLC | 05a63929-fccd-2936-e063-6294a90aeac5 | 2023-12-23 | Warnings | M018 |
| Meijer Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Meijer Distribution, Inc. | 9feadde4-fbe5-0c9e-e053-2995a90a9b30 | 2023-12-22 | Warnings | M018 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1241471 | carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic Solution | PSN | aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0 | 16 |
| 1241471 | carboxymethylcellulose sodium 5 MG/ML / glycerin 10 MG/ML / polysorbate 80 5 MG/ML Ophthalmic Solution | SCD | aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0 | 16 |
| 1241471 | carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic Solution | SY | aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0023-4307-02 | 00023430702 | 1 BOTTLE in 1 CARTON (0023-4307-02) / 2 mL in 1 BOTTLE | 1 bottle | 2011-11-30 | 0000-00-00 | Yes | No | Current |
| 0023-4307-03 | 00023430703 | 1 BOTTLE, DROPPER in 1 CARTON (0023-4307-03) > 3 mL in 1 BOTTLE, DROPPER | 2011-11-30 | 0000-00-00 | Yes | No | Current | |
| 0023-4307-10 | 00023430710 | 1 BOTTLE, DROPPER in 1 CARTON (0023-4307-10) / 10 mL in 1 BOTTLE, DROPPER | 2011-11-30 | 0000-00-00 | No | No | Current | |
| 0023-4307-15 | 00023430715 | 1 BOTTLE in 1 CARTON (0023-4307-15) > 15 mL in 1 BOTTLE | 1 bottle | 2011-11-30 | 0000-00-00 | No | No | Current |
| 0023-4307-20 | 00023430720 | 2 BOTTLE, DROPPER in 1 CARTON (0023-4307-20) / 10 mL in 1 BOTTLE, DROPPER | 2011-11-30 | 0000-00-00 | No | No | Current |