FDA.reportPublic FDA data

Rohto

Product NDC
10742-8143
11-digit product format
107428143
Labeler code
10742
Product ID
10742-8143_2978c996-d366-daff-e063-6394a90abe0b
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
2005-09-27
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
Ice
Listing expiration
2026-12-31

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
10742-8143-12023-02-08C16284748780-1f386c649-e1eb-0266-e053-dadaa90a7c1aDrug Facts
10742-8143-12023-01-30C16284748780-1f386c649-e1eb-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8143-1RohtoIce13 mL in 1 BOTTLE, WITH APPLICATORLIQUID1315
10742-8143-1RohtoIce1 in 1 CARTONLIQUID115

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYPROMELLOSESACTIVE INGREDIENT3NXW29V3WOROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]6
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]6
ZINC SULFATEACTIVE INGREDIENT89DS0H96TBROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]6
HYPROMELLOSESACTIVE MOIETY3NXW29V3WOROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]6
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077ROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]6
ZINC CATIONACTIVE MOIETY13S1S8SF37ROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]6
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4ROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]6
MENTHOLINACTIVE INGREDIENTL7T10EIP3AROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]6
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]6
WATERINACTIVE INGREDIENT059QF0KO0RROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8143ROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]15Current NDC, Legacy NDC, 2 package rows20241219_209bcec8-fbb4-4079-8ae2-810c48f3de93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098640hypromellose 0.2 % / tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN209bcec8-fbb4-4079-8ae2-810c48f3de9315
1098640hypromellose 2 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD209bcec8-fbb4-4079-8ae2-810c48f3de9315
1098640hypromellose 0.2 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY209bcec8-fbb4-4079-8ae2-810c48f3de9315
1098640hypromellose 2 MG/ML / Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY209bcec8-fbb4-4079-8ae2-810c48f3de9315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10742-8143-1107428143011 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8143-1) / 13 mL in 1 BOTTLE, WITH APPLICATOR2005-09-270000-00-00NoNoCurrent