Rohto

Product NDC
66613-8459
11-digit product format
666138459
Labeler code
66613
Product ID
66613-8459_29ab2269-62a8-00b9-e063-6394a90aaf5b
Type
HUMAN OTC DRUG
Nonproprietary name
Hypromellose, Povidone
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Rohto Pharmaceutical Co., Ltd.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-30
Substance
HYPROMELLOSE, UNSPECIFIED; POVIDONE
Active strength
3; 5 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rohto
Brand name suffix
Dual Light Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYPROMELLOSE, UNSPECIFIED3 mg/mL
POVIDONE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3NXW29V3WO, FZ989GH94E
Rxcui2604775

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66613-8459-1RohtoDual Light Relief1 in 1 CARTONLIQUID12
66613-8459-1RohtoDual Light Relief18 mL in 1 BOTTLE, DISPENSINGLIQUID182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66613-8459ROHTO DUAL LIGHT RELIEF (HYPROMELLOSE, POVIDONE) LIQUID [ROHTO PHARMACEUTICAL CO., LTD.]2Current NDC, 2 package rows20241222_1bbde83e-a64e-1a0f-e063-6394a90af4ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2604775hypromellose 0.3 % / povidone 0.5 % Ophthalmic SolutionPSN1bbde83e-a64e-1a0f-e063-6394a90af4ff2
2604775hypromellose 3 MG/ML / povidone 5 MG/ML Ophthalmic SolutionSCD1bbde83e-a64e-1a0f-e063-6394a90af4ff2
2604775hypromellose 0.3 % / povidone 0.5 % Ophthalmic SolutionSY1bbde83e-a64e-1a0f-e063-6394a90af4ff2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
66613-8459-1666138459011 BOTTLE, DISPENSING in 1 CARTON (66613-8459-1) / 18 mL in 1 BOTTLE, DISPENSING2024-05-30NoNoHistorical