Refresh Optive Mega-3 PF

Product NDC: 0023-3988
11-digit product format: 000233988
Labeler code: 0023
Product ID: 0023-3988_f1b7ee33-3765-45ca-8cf5-86422e001757
Type: HUMAN OTC DRUG
Nonproprietary name: carboxymethylcellulose sodium, Glycerin, Polysorbate 80
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Allergan, Inc.
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-03-01
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: 2027-12-31
Current FDA listing: Yes

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.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0023-3988-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0023-3988-10	`f5e01cc5f278…`	`a2eaf40c39c3…`

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 Mega-3 PF
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBOXYMETHYLCELLULOSE SODIUM	5 mg/mL
GLYCERIN	10 mg/mL
POLYSORBATE 80	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K679OBS311	Internal UNII lookup
PDC6A3C0OX	Internal UNII lookup
6OZP39ZG8H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1241471	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
326cb5d6-c784-404f-9a13-6d69262dda6e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	SPL version
0023-3988-05	Refresh Optive Mega-3 PF	10 mL in 1 VIAL	SOLUTION/ DROPS	10	5
0023-3988-05	Refresh Optive Mega-3 PF	1 in 1 CARTON	SOLUTION/ DROPS	1	5
0023-3988-10	Refresh Optive Mega-3 PF	1 in 1 CARTON	SOLUTION/ DROPS	1	5
0023-3988-10	Refresh Optive Mega-3 PF	10 mL in 1 VIAL	SOLUTION/ DROPS	10	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-3988-10	ML - Milliliter	0023-3988	f20d6031-a4d5-44f4-89fc-3f326c05eec9	1	2026-03-17

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.

Matched openFDA labels page 10 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Winco Original Formula Eye Drops	TETRAHYDROZOLINE HCL	WinCo Foods, LLC	44266952-4054-4c12-b3fc-d0543fe54fe2	2025-12-30	Warnings	Exact identifier application number: M018
Winco Irritation Relief Eye	TETRAHYDROZOLINE HCL, ZINC SULFATE	WinCo Foods, LLC	60565184-5745-43a5-92b2-ab45b27e8bc6	2025-12-30	Warnings	Exact identifier application number: M018
Core Values Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Liberty Procurement Co. Inc.	f8285f68-c40c-19a8-e053-6394a90aacad	2025-12-30	Warnings	Exact identifier application number: M018
Core Values Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Liberty Procurement Co., Inc.	f76dfeca-4e86-0b5d-e053-6294a90a29b9	2025-12-30	Warnings	Exact identifier application number: M018
Best Choice Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	Best Choice (Valu Merchandisers Company)	f5e665e4-ebd7-8c35-e053-2995a90a8811	2025-12-30	Warnings	Exact identifier application number: M018
Harris Teeter Eye Drops Artificial Tears	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Harris Teeter, LLC.	f82957d9-c4ad-a914-e053-6294a90aac50	2025-12-30	Warnings	Exact identifier application number: M018
Best Choice Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Valu Merchandisers, Co.	f7491a17-8035-5a3c-e053-6294a90a615c	2025-12-30	Warnings	Exact identifier application number: M018
Winco Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	WinCo Foods, LLC	f10778c8-14fe-4852-8b73-42db502fd2bc	2025-12-30	Warnings	Exact identifier application number: M018
Harris Teeter Eye Drops Maximum Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Harris Teeter, LLC	f710d107-0403-21c5-e053-6394a90a0372	2025-12-30	Warnings	Exact identifier application number: M018
CVS Astringent Eye	TETRAHYDROZOLINE HCL, ZINC SULFATE	CVS Pharmacy, Inc.	07e1a56b-fdad-408d-bf5a-7a0144ece131	2025-12-30	Warnings	Exact identifier application number: M018
Harris Teeter Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Harris Teeter, LLC	f76e2831-5c6c-7a62-e053-6294a90a937b	2025-12-30	Warnings	Exact identifier application number: M018
CVS Gentle Tears	DEXTRAN 70, HYPROMELLOSE	CVS Pharmacy, Inc.	9b1ea0eb-c34f-6603-e053-2995a90a6a95	2025-12-30	Warnings	Exact identifier application number: M018
CVS Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	CVS Pharmacy, Inc.	8eef499d-c60e-9468-e053-2995a90a8714	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Lubricating Tears Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	0042337b-c22a-157a-e063-6394a90a202e	2025-12-30	Warnings	Exact identifier application number: M018
CVS Lubricant Eye Drops Original	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CVS	bb1ad35a-79ea-639f-e053-2995a90a96f3	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Advanced Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL	Strategic Sourcing Services LLC	0019cd99-b245-2ffc-e063-6294a90a9f27	2025-12-30	Warnings	Exact identifier application number: M018
CVS Multi-Symptom Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	CVS Pharmacy, Inc.	be3d7855-cc66-ace8-e053-2a95a90ab8f4	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Dry Eye Relief	POLYETHYLENE GLYCOL 400	Strategic Sourcing Services LLC	0018ade9-5856-db6c-e063-6394a90a2ccf	2025-12-30	Warnings	Exact identifier application number: M018
CareOne Itchy Relief Eye Drops 15mL	TETRAHYDROZOLINE HCI, ZINC SULFATE	Retail Business Services, LLC.	997f16ff-2632-2e9d-e053-2995a90a6f51	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Strategic Sourcing Services LLC	0042e9a0-9693-d7e0-e063-6294a90ae6c6	2025-12-30	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN
6OZP39ZG8H	POLYSORBATE 80	9005-65-6	POLYSORBATE 80

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1241471	carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic Solution	PSN	326cb5d6-c784-404f-9a13-6d69262dda6e	5
1241471	carboxymethylcellulose sodium 5 MG/ML / glycerin 10 MG/ML / polysorbate 80 5 MG/ML Ophthalmic Solution	SCD	326cb5d6-c784-404f-9a13-6d69262dda6e	5
1241471	carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic Solution	SY	326cb5d6-c784-404f-9a13-6d69262dda6e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0023-3988-05	00023398805	1 VIAL in 1 CARTON (0023-3988-05) / 10 mL in 1 VIAL	1 vial	2026-03-01	Yes	No	Current
0023-3988-10	00023398810	1 VIAL in 1 CARTON (0023-3988-10) / 10 mL in 1 VIAL	1 vial	2026-03-01	No	No	Current