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 |
|---|---|---|---|---|---|---|
| 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 |
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 |