FDA.reportPublic FDA data

Refresh Relieva PF Xtra

Product NDC
0023-3782
11-digit product format
000233782
Labeler code
0023
Product ID
0023-3782_b6ddb19b-f29a-4a65-ac95-33420c2bd4bf
Type
HUMAN OTC DRUG
Nonproprietary name
Carboxymethylcellulose Sodium and Glycerin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-01
Substance
CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN
Active strength
5; 9 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

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 Relieva PF Xtra
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOXYMETHYLCELLULOSE SODIUM5 mg/mL
GLYCERIN9 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K679OBS311Internal UNII lookup
PDC6A3C0OXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1100650Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b51b8a75-8faa-430f-8f7e-ee58d3d13f2eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-3782-10Refresh Relieva PF Xtra1 in 1 CARTONSOLUTION/ DROPS15
0023-3782-10Refresh Relieva PF Xtra10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105
0023-3782-20Refresh Relieva PF Xtra2 in 1 CARTONSOLUTION/ DROPS25
0023-3782-20Refresh Relieva PF Xtra10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105
0023-3782-35Refresh Relieva PF Xtra1 in 1 CARTONSOLUTION/ DROPS15
0023-3782-35Refresh Relieva PF Xtra10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105
0023-3782-50Refresh Relieva PF Xtra3.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS3.55
0023-3782-50Refresh Relieva PF Xtra1 in 1 CARTONSOLUTION/ DROPS15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-3782-10ML - Milliliter0023-37823127801c-16b2-4bd1-a846-8eb925ff18dc12024-05-16
0023-3782-20ML - Milliliter0023-378243f3c3fc-2482-4e42-827c-a4aa114c177012025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-3782REFRESH RELIEVA PF XTRA (CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN) SOLUTION/ DROPS [ALLERGAN, INC.]2Current NDC, 8 package rows20240608_b51b8a75-8faa-430f-8f7e-ee58d3d13f2e.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.

Matched openFDA labels page 23 of 25 · 486 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUMThe Kroger Co.046f4ebc-d8f9-4755-b6ba-790fe86f31282023-12-20WarningsExact identifier
application number: M018
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
application number: M018
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
application number: M018
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
application number: M018
Topcare Health Ultra Itch Relief Astringent Eye DropsTETRAHYDROZOLINE HCL, ZINC SULFATETopco Associates LLC9c617e34-fc64-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
application number: M018
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
application number: M018
Topcare Health Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTopco Assoc LLC9c6284f9-00bb-37b5-e053-2a95a90ae2ee2023-12-20WarningsExact identifier
application number: M018
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
application number: M018
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
application number: M018
Topcare Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDETopco Assoc LLC9c6193a6-d824-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
application number: M018
HEB Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHEB5d522e4d-d647-486f-a947-25c14b1417fa2023-12-20WarningsExact identifier
application number: M018
HEB A.C. Eye DropsTETRAHYDROZOLINE HCL, ZINC SULFATEHEB Grocery Company., LPf680a8c1-dc91-7a52-e053-2a95a90a571e2023-12-20WarningsExact identifier
application number: M018
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
application number: M018
Equaline Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEUnited Natural Foods, Inc.f5f894f0-1ab0-4cad-e053-2995a90a7cba2023-12-20WarningsExact identifier
application number: M018
Cleareyes Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINLil' Drug Store Products, Inc.39e4ab2b-ae12-4339-b219-109cf0f7f06a2023-12-15WarningsExact identifier
application number: M018
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.db3a6c68-320b-46b0-83fa-6c29297a84a62023-12-15WarningsExact identifier
application number: M018
SystanePOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLAlcon Research Ltd14916d2c-a63d-491e-bd91-a61f300af38a2023-12-15WarningsExact identifier
application number: M018
SystaneHYPROMELLOSEAlcon Laboratories, Inc.5f74b161-ae41-d0e2-6ed9-8deca55d2c0f2023-12-15WarningsExact identifier
application number: M018
Systane Day and Night Value PackPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%Alcon Laboratories, Inc.df13ca6f-7ce1-455a-ae13-9bbc5e9d2e072023-12-15WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100650carboxymethylcellulose sodium 0.5 % / glycerin 0.9 % Ophthalmic SolutionPSNb51b8a75-8faa-430f-8f7e-ee58d3d13f2e5
1100650carboxymethylcellulose sodium 5 MG/ML / glycerin 9 MG/ML Ophthalmic SolutionSCDb51b8a75-8faa-430f-8f7e-ee58d3d13f2e5
1100650carboxymethylcellulose sodium 0.5 % / glycerin 0.9 % Ophthalmic SolutionSYb51b8a75-8faa-430f-8f7e-ee58d3d13f2e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0023-3782-10000233782101 BOTTLE, DROPPER in 1 CARTON (0023-3782-10) / 10 mL in 1 BOTTLE, DROPPER2024-03-01NoNoCurrent
0023-3782-20000233782202 BOTTLE, DROPPER in 1 CARTON (0023-3782-20) / 10 mL in 1 BOTTLE, DROPPER2025-10-15NoNoCurrent
0023-3782-35000233782351 BOTTLE, DROPPER in 1 CARTON (0023-3782-35) / 10 mL in 1 BOTTLE, DROPPER2024-03-01NoNoCurrent
0023-3782-50000233782501 BOTTLE, DROPPER in 1 CARTON (0023-3782-50) / 3.5 mL in 1 BOTTLE, DROPPER2024-03-01YesNoCurrent