Family Wellness Original Redness Relief Eye Drops

Product NDC
55319-907
11-digit product format
553190907
Labeler code
55319
Product ID
55319-907_474528d1-7e7a-a211-e063-6294a90ae3c5
Type
HUMAN OTC DRUG
Nonproprietary name
Tetrahydrozoline HCl
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Family Dollar Services, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-12
Substance
TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
.05 g/100mL
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
Family Wellness Original Redness Relief Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0YZT43HS7DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1052943Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fabf540a-8d5c-bb1c-e053-6394a90a75c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-907-01Family Wellness Original Redness Relief Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
55319-907-01Family Wellness Original Redness Relief Eye Drops1 in 1 BOXSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-907FAMILY WELLNESS ORIGINAL REDNESS RELIEF EYE DROPS (TETRAHYDROZOLINE HCL) SOLUTION/ DROPS [FAMILY DOLLAR SERVICES, INC.]3Current NDC, 2 package rows20231224_fabf540a-8d5c-bb1c-e053-6394a90a75c2.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 22 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Maximum Redness Relief and LubricantGLYCERIN, NAPHAZOLINE HCIMeijer Distribution, Inc.9feb1818-c79b-23bf-e053-2995a90a10842023-12-22WarningsExact identifier
application number: M018
Meijer Redness ReliefTETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea27a5-b81b-1598-e053-2995a90a6b622023-12-22WarningsExact identifier
application number: M018
Meijer Seasonal Itching and Redness ReliefTETRAHYDROZOLINE HCI, ZINC SULFATEMeijer Distribution, Inc.9fead2de-2fe6-4dab-e053-2995a90a27422023-12-22WarningsExact identifier
application number: M018
Meijer Artificial TearsPOLYVINYL ALCOHOL, POVIDONEMeijer Distribution, Inc.9feb3eec-a36f-8fc7-e053-2a95a90adcd32023-12-22WarningsExact identifier
application number: M018
Meijer Redness ReliefGLYCERIN, NAPHAZOLINE HCIMeijer Distribution, Inc.9fea4e43-7525-bb66-e053-2a95a90acee92023-12-22WarningsExact identifier
application number: M018
Meijer Ultra Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.a0846e3e-687c-fd55-e053-2995a90a673e2023-12-22WarningsExact identifier
application number: M018
Meijer Advanced Redness and Irritation ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea6d7a-a2cd-d26e-e053-2995a90a15f82023-12-22WarningsExact identifier
application number: M018
Meijer Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Meijer Distribution, Inc.9feaa5e2-6aca-96e8-e053-2a95a90a54bd2023-12-22WarningsExact identifier
application number: M018
Walgreens Multi-Symptom Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEWalgreen Co.a03789ce-66bd-7b12-e053-2995a90af85a2023-12-20WarningsExact identifier
application number: M018
Walgreens Lubricant Eye Drops Preservative FreeDEXTRAN 70, HYPROMELLOSEWalgreen Company9b383e41-e116-1c12-e053-2a95a90ab25f2023-12-20WarningsExact identifier
application number: M018
Walgreens Eye Drops Maximum Redness Relief 15mLGLYCERIN, NAPHAZOLINE HCIWalgreen Company949d4a4d-b0f8-81f8-e053-2995a90a818d2023-12-20WarningsExact identifier
application number: M018
Walgreens Eye Drops Seasonal Relief 15mLTETRAHYDROZOLINE HCI, ZINC SULFATEWalgreen Co.947f3706-ef5e-2c53-e053-2a95a90a82bd2023-12-20WarningsExact identifier
application number: M018
Walgreens Eye Drops Advanced Relief 15mLDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIWalgreen Company949f5560-fba7-2da8-e053-2995a90a23c22023-12-20WarningsExact identifier
application number: M018
Walgreens Lubricant Eye Drops Preservative FreeCARBOXYMETHYLCELLULOSE SODIUMWalgreen Company9912b773-e7a5-3a82-e053-2995a90a5b2c2023-12-20WarningsExact identifier
application number: M018
Walgreens Lubricant Eye Drops High Performance 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94ee8310-1c19-dfd4-e053-2a95a90a83562023-12-20WarningsExact identifier
application number: M018
Walgreens Redness Relief Eye Drops 15mLGLYCERIN, NAPHAZOLINE HCIWalgreen Company94a0d08a-a6db-1088-e053-2995a90ab4fd2023-12-20WarningsExact identifier
application number: M018
Walgreens Eye Drops Original 15mL and twin packTETRAHYDROZOLINE HCIWalgreens Company94e391f7-db4b-47d2-e053-2a95a90a1b112023-12-20WarningsExact identifier
application number: M018
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94f6e1cd-073c-61ca-e053-2a95a90ae7252023-12-20WarningsExact identifier
application number: M018
Lubricant Eye Drops Preservative FreeCARBOXYMETHYLCELLULOSE SODIUMTarget Corporation454ce049-49e5-48b1-8499-048e5e7d72d32023-12-20WarningsExact identifier
application number: M018
Rugby Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratoriesf9292d5d-e0a3-9287-e053-6294a90a43e92023-12-20WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSNfabf540a-8d5c-bb1c-e053-6394a90a75c24
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDfabf540a-8d5c-bb1c-e053-6394a90a75c24
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSYfabf540a-8d5c-bb1c-e053-6394a90a75c24
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSYfabf540a-8d5c-bb1c-e053-6394a90a75c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55319-907-01553190907011 BOTTLE, DROPPER in 1 BOX (55319-907-01) / 15 mL in 1 BOTTLE, DROPPER2023-08-12NoNoCurrent