FDA.reportPublic FDA data

Rohto

Product NDC
10742-8146
11-digit product format
107428146
Labeler code
10742
Product ID
10742-8146_2978e2bc-c901-60bb-e063-6394a90a47a7
Type
HUMAN OTC DRUG
Nonproprietary name
Hypromellose, Tetrahydrozoline hydrochloride, Zinc sulfate
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
The Mentholatum Company
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-21
Substance
HYPROMELLOSE, UNSPECIFIED; TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE, UNSPECIFIED FORM
Active strength
2; .5; 2.5 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
All-In-One
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYPROMELLOSE, UNSPECIFIED2 mg/mL
TETRAHYDROZOLINE HYDROCHLORIDE.5 mg/mL
ZINC SULFATE, UNSPECIFIED FORM2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3NXW29V3WO, 0YZT43HS7D, 89DS0H96TB
Rxcui1098640

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8146-12023-02-08C16284748780-1f386c649-adf7-0266-e053-dadaa90a7c1aDrug Facts
10742-8146-12023-02-08C16284748780-1f386c649-adf7-0266-e053-dadaa90a7c1aDrug Facts
10742-8146-12023-01-30C16284748780-1f386c649-adf7-0266-e053-dadaa90a7c1aDrug Facts
10742-8146-12023-01-30C16284748780-1f386c649-adf7-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8146-1RohtoAll-In-One1 in 1 CARTONLIQUID13
10742-8146-1RohtoAll-In-One13 mL in 1 BOTTLE, WITH APPLICATORLIQUID133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8146ROHTO ALL-IN-ONE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]3Current NDC, Legacy NDC, 2 package rows20241219_43e690e4-b381-46e3-838c-33aef5bdadde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098640hypromellose 0.2 % / tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN43e690e4-b381-46e3-838c-33aef5bdadde3
1098640hypromellose 2 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD43e690e4-b381-46e3-838c-33aef5bdadde3
1098640hypromellose 0.2 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY43e690e4-b381-46e3-838c-33aef5bdadde3
1098640hypromellose 2 MG/ML / Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY43e690e4-b381-46e3-838c-33aef5bdadde3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10742-8146-1107428146011 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8146-1) / 13 mL in 1 BOTTLE, WITH APPLICATOR2021-06-210000-00-00NoNoCurrent