FDA.reportPublic FDA data

Family Wellness Maximum Redness Relief Eye Drops

Product NDC
55319-909
11-digit product format
553190909
Labeler code
55319
Product ID
55319-909_47451eaa-897f-aa74-e063-6394a90ae040
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin, Naphazoline 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
GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
Active strength
.5; .03 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

Additional Listing Data#

Finished product
Yes
Brand name base
Family Wellness Maximum Redness Relief Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX, MZ1131787D
Rxcui1235200

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-909-01Family Wellness Maximum Redness Relief Eye Drops1 in 1 BOXSOLUTION/ DROPS14
55319-909-01Family Wellness Maximum Redness Relief Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-909FAMILY WELLNESS MAXIMUM REDNESS RELIEF EYE DROPS (GLYCERIN, NAPHAZOLINE HCL) SOLUTION/ DROPS [FAMILY DOLLAR SERVICES, INC.]3Current NDC, 2 package rows20231224_facd53c4-9cfc-6589-e053-6394a90a180d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235200glycerin 0.5 % / naphazoline HCl 0.03 % Ophthalmic SolutionPSNfacd53c4-9cfc-6589-e053-6394a90a180d4
1235200glycerin 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic SolutionSCDfacd53c4-9cfc-6589-e053-6394a90a180d4
1235200glycerin 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic SolutionSYfacd53c4-9cfc-6589-e053-6394a90a180d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55319-909-01553190909011 BOTTLE, DROPPER in 1 BOX (55319-909-01) / 15 mL in 1 BOTTLE, DROPPER2023-08-12NoNoHistorical