FDA.reportPublic FDA data

Pure Eyes Sterile Eyes

Product NDC
20146-7000
11-digit product format
201467000
Labeler code
20146
Product ID
20146-7000_103fe3bc-124a-4ce6-a1b1-fa96935d0fd9
Type
HUMAN OTC DRUG
Nonproprietary name
Naphazoline Hydrochloride and Glycerin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
SAMSON PHARMACEUTICAL
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-01
Substance
GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
Active strength
2.5; .1 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

Additional Listing Data#

Finished product
Yes
Brand name base
Pure Eyes Sterile Eyes
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN2.5 mg/mL
NAPHAZOLINE HYDROCHLORIDE.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX, MZ1131787D
Rxcui1046700

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
20146-7000-12024-01-30C16284748780-19d75b9d0-ca6c-f424-e053-dadaa90a57cePure Eyes ® Sterile Eyes
20146-7000-12022-01-31C16284748780-19d75b9d0-ca6c-f424-e053-dadaa90a57cePure Eyes ® Sterile Eyes
20146-7000-12022-01-28C16284748780-19d75b9d0-ca6c-f424-e053-dadaa90a57cePure Eyes ® Sterile Eyes
20146-7000-12020-02-12C16284748780-19d75b9d0-ca6c-f424-e053-dadaa90a57cePure Eyes ® Sterile Eyes
20146-7000-12020-01-31C16284748780-19d75b9d0-ca6c-f424-e053-dadaa90a57cePure Eyes ® Sterile Eyes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
20146-7000-1Pure Eyes Sterile Eyes7 mL in 1 BOTTLESOLUTION/ DROPS75
20146-7000-1Pure Eyes Sterile Eyes1 in 1 BLISTER PACKSOLUTION/ DROPS15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GlycerinACTIVE INGREDIENTPDC6A3C0OXPURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]1
Naphazoline HydrochlorideACTIVE INGREDIENTMZ1131787DPURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]1
GlycerinACTIVE MOIETYPDC6A3C0OXPURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]1
NaphazolineACTIVE MOIETYH231GF11BVPURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]1
boric acidINACTIVE INGREDIENTR57ZHV85D4PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KPURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]1
sodium borateINACTIVE INGREDIENT91MBZ8H3QOPURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]1
waterINACTIVE INGREDIENT059QF0KO0RPURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
20146-7000PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]3Current NDC, Legacy NDC, 2 package rows20220201_c0234e82-211f-4731-ac48-12db13b16e8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionPSNc0234e82-211f-4731-ac48-12db13b16e8a5
1046700glycerin 2.5 MG/ML / naphazoline hydrochloride 0.12 MG/ML Ophthalmic SolutionSCDc0234e82-211f-4731-ac48-12db13b16e8a5
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionSYc0234e82-211f-4731-ac48-12db13b16e8a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
20146-7000-1201467000011 BOTTLE in 1 BLISTER PACK (20146-7000-1) / 7 mL in 1 BOTTLE1 bottle2015-01-010000-00-00NoNoCurrent