FDA.reportPublic FDA data

CVS Maximum Redness Relief

Product NDC
51316-837
11-digit product format
513160837
Labeler code
51316
Product ID
51316-837_474514b6-e7c8-a448-e063-6394a90a459f
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin, Naphazoline HCI
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
CVS Pharmacy, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-24
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
CVS Maximum Redness Relief
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-837-01CVS Maximum Redness Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153
51316-837-01CVS Maximum Redness Relief1 in 1 BOXSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-837CVS MAXIMUM REDNESS RELIEF (GLYCERIN, NAPHAZOLINE HCI) SOLUTION/ DROPS [CVS PHARMACY, INC.]2Current NDC, 2 package rows20240103_f70f9fc4-4022-336e-e053-6394a90a4d07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235200glycerin 0.5 % / naphazoline HCl 0.03 % Ophthalmic SolutionPSNf70f9fc4-4022-336e-e053-6394a90a4d073
1235200glycerin 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic SolutionSCDf70f9fc4-4022-336e-e053-6394a90a4d073
1235200glycerin 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic SolutionSYf70f9fc4-4022-336e-e053-6394a90a4d073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51316-837-01513160837011 BOTTLE, DROPPER in 1 BOX (51316-837-01) / 15 mL in 1 BOTTLE, DROPPER2023-03-24NoNoHistorical