FDA.reportPublic FDA data

Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops

Product NDC
0536-1408
11-digit product format
005361408
Labeler code
0536
Product ID
0536-1408_47353eb5-bb01-f7e5-e063-6394a90ab152
Type
HUMAN OTC DRUG
Nonproprietary name
Polyvinyl alcohol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Rugby Laboratories
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-19
Substance
POLYVINYL ALCOHOL, UNSPECIFIED
Active strength
1.4 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYVINYL ALCOHOL, UNSPECIFIED1.4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii532B59J990
Rxcui142004

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1408-94Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
0536-1408-94Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops1 in 1 BOXSOLUTION/ DROPS12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1408-94ML - Milliliter0536-14084ae003aa-776e-4e2c-9709-94cb83c06b0c12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1408RUGBY POLYVINYL ALCOHOL 1.4% LUBRICATING EYE DROPS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [RUGBY LABORATORIES]1Current NDC, 2 package rows20231020_081673b2-5c74-1200-e063-6394a90ae363.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142004polyvinyl alcohol 1.4 % Ophthalmic SolutionPSN081673b2-5c74-1200-e063-6394a90ae3632
142004polyvinyl alcohol 1.4 % Ophthalmic SolutionPSN2653e4fc-4f08-426d-a0a4-31d647c1de562
142004polyvinyl alcohol 0.014 ML/ML Ophthalmic SolutionSCD081673b2-5c74-1200-e063-6394a90ae3632
142004polyvinyl alcohol 0.014 ML/ML Ophthalmic SolutionSCD2653e4fc-4f08-426d-a0a4-31d647c1de562
142004polyvinyl alcohol 1.4 % Ophthalmic SolutionSY081673b2-5c74-1200-e063-6394a90ae3632
142004polyvinyl alcohol 1.4 % Ophthalmic SolutionSY2653e4fc-4f08-426d-a0a4-31d647c1de562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0536-1408-94005361408941 BOTTLE, DROPPER in 1 BOX (0536-1408-94) / 15 mL in 1 BOTTLE, DROPPER2023-10-19NoNoHistorical