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 8 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EYE DROPS	CARBOXYMETHYLCELLULOSE SODIUM	Foshan Sugar Max Cosmetics CO.,Ltd	26dbf100-593e-3778-e063-6394a90adf26	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Original Formula	TETRAHYDROZOLINE HCL	Geiss, Destin & Dunn, Inc.	9b44de58-6362-3811-e053-2995a90a2f37	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Redness Relief Plus	GLLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Geiss, Destin & Dunn, Inc.	9b37250f-9bdf-574e-e053-2a95a90a013e	2025-12-30	Warnings	Exact identifier application number: M018
CVS Advanced Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	CVS Pharmacy, Inc.	f74a2fca-902c-f68a-e053-6394a90abb88	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Irritation Relief	TETRAHYDROZOLINE HCL, ZINC SULFATE	Geiss, Destin & Dunn, Inc.	9b24fbdd-780c-1ba2-e053-2a95a90ad60f	2025-12-30	Warnings	Exact identifier application number: M018
CVS Hydration Eye Drops	POLYETYLENE GLYCOL 400, PROPYLENE GLYCOL	CVS	ecab8fa3-6575-0dde-e053-2a95a90abd61	2025-12-30	Warnings	Exact identifier application number: M018
Good Sense Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Geiss, Destin & Dunn, Inc.	9b243301-2e4b-5706-e053-2995a90a9b90	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Geiss, Derstin & Dunn, Inc.	9b34de99-13df-201a-e053-2a95a90ae559	2025-12-30	Warnings	Exact identifier application number: M018
Good Sense Lubricating Plus Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	GoodSense	ffd6428e-3bf5-8742-e053-6394a90a4c8f	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Ultra Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Geiss, Destin & Dunn, Inc.	9b45ebb5-c43b-c9fb-e053-2a95a90a3411	2025-12-30	Warnings	Exact identifier application number: M018
CVS Maximum Redness Relief	GLYCERIN, NAPHAZOLINE HCI	CVS Pharmacy, Inc.	f70f9fc4-4022-336e-e053-6394a90a4d07	2025-12-30	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Discount Drug Mart, Inc.	f75c2f84-a28c-5807-e053-6294a90a2295	2025-12-30	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Discount Drug Mart	f7fd53be-e501-d97f-e053-6394a90ad409	2025-12-30	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	Discount Drug Mart	f5f1d3da-5300-8211-e053-2a95a90a323a	2025-12-30	Warnings	Exact identifier application number: M018
Exchange Select Eye Drops Advanced Relief Moisturizer	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Army and Air Force Exchange Service	9e475240-2df1-9bee-e053-2995a90a8d4b	2025-12-30	Warnings	Exact identifier application number: M018
Family Wellness Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Family Dollar Services, Inc.	facd53c4-9cfc-6589-e053-6394a90a180d	2025-12-30	Warnings	Exact identifier application number: M018
Exchange Select Artificial Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Army and Air Force Exchange Service	9e478343-8ae7-823e-e053-2995a90a84ed	2025-12-30	Warnings	Exact identifier application number: M018
Family Wellness Advanced Redness Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL	Family Dollar Services, Inc.	fabec215-a040-3f4e-e053-6394a90ad45f	2025-12-30	Warnings	Exact identifier application number: M018
Family Wellness Original Redness Relief Eye Drops	TETRAHYDROZOLINE HCL	Family Dollar Services, Inc.	fabf540a-8d5c-bb1c-e053-6394a90a75c2	2025-12-30	Warnings	Exact identifier application number: M018
Family Wellness Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Family Dollar Services, Inc.	facd329b-1923-61df-e053-6294a90ab738	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