FDA.reportPublic FDA data

Walgreens Eye Drops Maximum Redness Relief 15mL

Product NDC
0363-4546
11-digit product format
003634546
Labeler code
0363
Product ID
0363-4546_0cf96ebf-f735-9152-e063-6394a90acad8
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin, Naphazoline HCI
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Walgreen Company
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-10
Substance
NAPHAZOLINE HYDROCHLORIDE; GLYCERIN
Active strength
.03; .5 g/100mL; g/100mL
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

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
Walgreens Eye Drops Maximum Redness Relief 15mL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPHAZOLINE HYDROCHLORIDE.03 g/100mL
GLYCERIN.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MZ1131787DInternal 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
1235200Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
949d4a4d-b0f8-81f8-e053-2995a90a818dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-4546-01Walgreens Eye Drops Maximum Redness Relief 15mL1 in 1 BOXSOLUTION/ DROPS12
0363-4546-01Walgreens Eye Drops Maximum Redness Relief 15mL15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4546WALGREENS EYE DROPS MAXIMUM REDNESS RELIEF 15ML (GLYCERIN, NAPHAZOLINE HCI) SOLUTION/ DROPS [WALGREEN COMPANY]2Current NDC, Legacy NDC, 2 package rows20240103_949d4a4d-b0f8-81f8-e053-2995a90a818d.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 3 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
application number: M018
Nano Eye Drop SerumWATER. SORBITOL.1.2-HEXANEDIOL GLYCERIN HYALURONATESODIUM.Shenzhen Yiyang Zhiting Technology Co., Ltd539567d6-488a-9b01-e063-6394a90abece2026-06-06WarningsExact identifier
application number: M018
REFRESH CELLUVISCCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.b32ed9e8-d091-4f16-b416-5a62cdfee49a2026-06-05WarningsExact identifier
application number: M018
VitaPhyte Redness Reliever Lubricant Eye DropsREDNESS RELIEVER LUBRICANT EYE DROPSGuangzhou Liyan Cosmetics Technology Co., Ltd.53d4e9b0-c9a0-797a-e063-6294a90ad0cf2026-06-04WarningsExact identifier
application number: M018
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Savings Distributors LLC558178eb-1eec-af0f-e063-6394a90afad92026-06-01WarningsExact identifier
application number: M018
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
application number: M018
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
application number: M018
Blink Triple Care Preservative FreePOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated65e67990-78b7-4ce9-963b-6bed3a6bed072026-05-27WarningsExact identifier
application number: M018
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
application number: M018
REFRESH LACRI-LUBEMINERAL OIL, PETROLATUMAllergan, Inc.d232a44b-516d-4cdf-a4e7-c3a9a50dc7af2026-05-15WarningsExact identifier
application number: M018
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporatedf1d07347-086f-43b2-aa5f-910764fc666e2026-05-13WarningsExact identifier
application number: M018
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
application number: M018
Sodium Hyaluronate Eye DropsSODIUM HYALURONATEGuangzhou Hechuang Commercial Service Co.,Ltd.5187d136-15c6-517b-e063-6294a90a811d2026-05-11WarningsExact identifier
application number: M018
Splash TearsHYPROMELLOSELABORATORIOS SOPHIA, S.A. DE C.V.a58a8478-9cc5-aa39-e053-2995a90a347d2026-05-08WarningsExact identifier
application number: M018
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
application number: M018
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
application number: M018
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
application number: M018
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235200glycerin 0.5 % / naphazoline HCl 0.03 % Ophthalmic SolutionPSN949d4a4d-b0f8-81f8-e053-2995a90a818d2
1235200glycerin 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic SolutionSCD949d4a4d-b0f8-81f8-e053-2995a90a818d2
1235200glycerin 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic SolutionSY949d4a4d-b0f8-81f8-e053-2995a90a818d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-4546-01003634546011 BOTTLE, DROPPER in 1 BOX (0363-4546-01) / 15 mL in 1 BOTTLE, DROPPER2019-10-100000-00-00NoNoCurrent