Rohto Digi-Eye

Product NDC
10742-8175
11-digit product format
107428175
Labeler code
10742
Product ID
10742-8175_29791cca-8e12-8094-e063-6394a90a863c
Type
HUMAN OTC DRUG
Nonproprietary name
Hypromellose, Tetrahydrozoline hydrochloride
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
The Mentholatum Company
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-03-01
Substance
HYPROMELLOSE, UNSPECIFIED; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
3.5; .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 Digi-Eye
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYPROMELLOSE, UNSPECIFIED3.5 mg/mL
TETRAHYDROZOLINE HYDROCHLORIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3NXW29V3WO, 0YZT43HS7D
Rxcui1098644

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8175-1Rohto Digi-Eye13 mL in 1 BOTTLE, WITH APPLICATORLIQUID136
10742-8175-1Rohto Digi-Eye1 in 1 CARTONLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8175ROHTO DIGI-EYE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE) LIQUID [THE MENTHOLATUM COMPANY]6Current NDC, Legacy NDC, 2 package rows20241219_5d6f37b9-b568-4cb6-92de-eb40779f3f8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098644hypromellose 0.35 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN5d6f37b9-b568-4cb6-92de-eb40779f3f8c6
1098644hypromellose 3.5 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD5d6f37b9-b568-4cb6-92de-eb40779f3f8c6
1098644hypromellose 0.35 % / tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY5d6f37b9-b568-4cb6-92de-eb40779f3f8c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10742-8175-1107428175011 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8175-1) / 13 mL in 1 BOTTLE, WITH APPLICATOR2018-03-010000-00-00NoNoCurrent