FDA.reportPublic FDA data

Pur-Wash

Product NDC
65785-168
11-digit product format
657850168
Labeler code
65785
Product ID
65785-168_445cc5f0-08a7-cb39-e063-6394a90abc68
Type
HUMAN OTC DRUG
Nonproprietary name
Eyewash
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Niagara Pharmaceuticals, Inc.
Application
NDA022305
Marketing category
NDA
Marketing start
2015-01-30
Substance
WATER
Active strength
465 mL/473mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pur-Wash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER465 mL/473mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii059QF0KO0R
Rxcui1151101, 1424605

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65785-168-012023-03-10C16284748780-1f386c64a-1ca4-0266-e053-dadaa90a7c1aNiagara Pur-Wash
65785-168-022023-03-10C16284748780-1f386c64a-1ca4-0266-e053-dadaa90a7c1aNiagara Pur-Wash
65785-168-012023-01-30C16284748780-1f386c64a-1ca4-0266-e053-dadaa90a7c1aNiagara Pur-Wash
65785-168-022023-01-30C16284748780-1f386c64a-1ca4-0266-e053-dadaa90a7c1aNiagara Pur-Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65785-168-01Pur-Wash473 mL in 1 BOTTLE, UNIT-DOSESOLUTION47313
65785-168-02Pur-Wash946 mL in 1 BOTTLE, UNIT-DOSESOLUTION94613

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WaterACTIVE INGREDIENT059QF0KO0RPUR-WASH (EYEWASH) SOLUTION [NIAGARA PHARMACEUTICALS, INC.]3
WaterACTIVE MOIETY059QF0KO0RPUR-WASH (EYEWASH) SOLUTION [NIAGARA PHARMACEUTICALS, INC.]3
Boric AcidINACTIVE INGREDIENTR57ZHV85D4PUR-WASH (EYEWASH) SOLUTION [NIAGARA PHARMACEUTICALS, INC.]3
Sodium BorateINACTIVE INGREDIENT91MBZ8H3QOPUR-WASH (EYEWASH) SOLUTION [NIAGARA PHARMACEUTICALS, INC.]3
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XPUR-WASH (EYEWASH) SOLUTION [NIAGARA PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65785-168PUR-WASH (EYEWASH) SOLUTION [NIAGARA PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20250130_0d43b1c1-2699-37f1-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1424605Pur-Wash 98.3 % Ophthalmic Irrigation SolutionPSN0d43b1c1-2699-37f1-e054-00144ff88e8813
1151101water 98.3 % Ophthalmic Irrigation SolutionPSN0d43b1c1-2699-37f1-e054-00144ff88e8813
1424605water 983 MG/ML Ophthalmic Irrigation Solution [Pur-Wash]SBD0d43b1c1-2699-37f1-e054-00144ff88e8813
1151101water 983 MG/ML Ophthalmic Irrigation SolutionSCD0d43b1c1-2699-37f1-e054-00144ff88e8813
1424605Pur-Wash 98.3 % Ophthalmic Irrigation SolutionSY0d43b1c1-2699-37f1-e054-00144ff88e8813
1424605Pur-Wash 983 MG/ML Ophthalmic Irrigation SolutionSY0d43b1c1-2699-37f1-e054-00144ff88e8813
1151101water 98.3 % Ophthalmic Irrigation SolutionSY0d43b1c1-2699-37f1-e054-00144ff88e8813
1151101water 98.3 % Ophthalmic Irrigation SolutionPSN9248ee71-2d47-620d-e053-2995a90af5c83
1151101water 983 MG/ML Ophthalmic Irrigation SolutionSCD9248ee71-2d47-620d-e053-2995a90af5c83
1151101water 98.3 % Ophthalmic Irrigation SolutionSY9248ee71-2d47-620d-e053-2995a90af5c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65785-168-0165785016801473 mL in 1 BOTTLE, UNIT-DOSE (65785-168-01) 473 ml2015-09-010000-00-00NoNoCurrent
65785-168-0265785016802946 mL in 1 BOTTLE, UNIT-DOSE (65785-168-02) 946 ml2015-09-010000-00-00NoNoCurrent