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 | 2026-10-12 | |
| excluded package | package | 0023-4307 | 0023-4307-15 | D | Discontinued by firm | 2026-10-12 |
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 |
|---|---|---|---|---|---|---|
| Visine Red Eye Total Comfort Multi-Symptom | TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORM | Kenvue Brands LLC | 5747edef-7a87-41d7-9594-6c78508b9ba2 | 2026-06-11 | Warnings | M018 |
| Nano Eye Drop Serum | WATER. SORBITOL.1.2-HEXANEDIOL GLYCERIN HYALURONATESODIUM. | Shenzhen Yiyang Zhiting Technology Co., Ltd | 539567d6-488a-9b01-e063-6394a90abece | 2026-06-06 | Warnings | M018 |
| REFRESH CELLUVISC | CARBOXYMETHYLCELLULOSE SODIUM | Allergan, Inc. | b32ed9e8-d091-4f16-b416-5a62cdfee49a | 2026-06-05 | Warnings | M018 |
| VitaPhyte Redness Reliever Lubricant Eye Drops | REDNESS RELIEVER LUBRICANT EYE DROPS | Guangzhou Liyan Cosmetics Technology Co., Ltd. | 53d4e9b0-c9a0-797a-e063-6294a90ad0cf | 2026-06-04 | Warnings | M018 |
| Rohto Digi-Eye | HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE | The Mentholatum Company | 5d6f37b9-b568-4cb6-92de-eb40779f3f8c | 2026-06-03 | Warnings | M018 |
| Visine Red Eye Hydrating Comfort Eye Drops | TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 | Savings Distributors LLC | 558178eb-1eec-af0f-e063-6394a90afad9 | 2026-06-01 | Warnings | M018 |
| C-More Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN | PROFOUND NUTRITION LIMITED | 78f04ecb-da5e-468c-81fe-70f7c26b76c2 | 2026-06-01 | Warnings | M018 |
| Peep Club | GLYCERIN | Peep Club Eyecare Corp. | 513d1988-2827-28d8-e063-6294a90a8d1f | 2026-05-28 | Warnings | M018 |
| Blink Triple Care Preservative Free | POLYETHYLENE GLYCOL 400 | Bausch & Lomb Incorporated | 65e67990-78b7-4ce9-963b-6bed3a6bed07 | 2026-05-27 | Warnings | M018 |
| Ripple | GLYCERIN, POVIDONE | CorneaCare Inc | 3b5ba197-d501-681e-e063-6294a90aefb5 | 2026-05-24 | Warnings | M018 |
| REFRESH LACRI-LUBE | MINERAL OIL, PETROLATUM | Allergan, Inc. | d232a44b-516d-4cdf-a4e7-c3a9a50dc7af | 2026-05-15 | Warnings | M018 |
| blink tears | POLYETHYLENE GLYCOL 400 | Bausch & Lomb Incorporated | f1d07347-086f-43b2-aa5f-910764fc666e | 2026-05-13 | Warnings | M018 |
| Systane Pro PF | PROPYLENE GLYCOL | Alcon Laboratories, Inc. | a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f1 | 2026-05-12 | Warnings | M018 |
| Sodium Hyaluronate Eye Drops | SODIUM HYALURONATE | Guangzhou Hechuang Commercial Service Co.,Ltd. | 5187d136-15c6-517b-e063-6294a90a811d | 2026-05-11 | Warnings | M018 |
| Splash Tears | HYPROMELLOSE | LABORATORIOS SOPHIA, S.A. DE C.V. | a58a8478-9cc5-aa39-e053-2995a90a347d | 2026-05-08 | Warnings | M018 |
| iVIZIA Lubricant Eye Gel | POVIDONE | Thea Pharma Inc. | 1f06ca1a-5270-9a82-e063-6294a90aed64 | 2026-04-29 | Warnings | M018 |
| GoodSense Eye Drops Advanced Relief Moisturizer | DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Preferred PHarmaceuticals Inc. | 011473a8-26d5-4661-b3c0-745f9b6aa1d8 | 2026-04-29 | Warnings | M018 |
| REFRESH TEARS PF | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN | Allergan, Inc. | 9e1cba7b-84ed-47f3-b19a-121992834350 | 2026-04-24 | Warnings | M018 |
| Sodium Chloride | SODIUM CHLORIDE | Method Pharmaceuticals, LLC | 4b08859e-65bd-8255-e063-6394a90af614 | 2026-04-23 | Warnings | M018 |
| Pure Eyes Sterile Eyes | NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN | SAMSON PHARMACEUTICAL | c0234e82-211f-4731-ac48-12db13b16e8a | 2026-04-21 | 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 |