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 UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3NXW29V3WOInternal UNII lookup
0YZT43HS7DInternal UNII lookup
89DS0H96TBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1098640Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
43e690e4-b381-46e3-838c-33aef5bdaddeAvailable on FDA.report

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#

Effective, Related label table
EffectiveRelated label
2023-02-08Drug Facts
2023-02-08Drug Facts
2023-01-30Drug Facts
2023-01-30Drug 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 26 · 512 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VedlubeMINERAL OIL AND WHITE PETROLATUM LUBRICANT EYE OINTMENTVEDCO INC55d126fa-7489-4307-824e-b6957e57d4e92026-07-31WarningsExact identifier
application number: M018
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
application number: M018
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
application number: M018
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
application number: M018
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
application number: M018
Polyvinyl AlcoholPOLYVINYL ALCOHOLAvPAKf18b61da-4033-341a-e053-2a95a90a8ebf2026-07-07WarningsExact identifier
application number: M018
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
application number: M018
Retaine CMCCARBOXYMETHYLCELLULOSE SODIUMOCuSOFT LLCa3698c71-0c80-4246-be52-5e7d96f6c5402026-07-06WarningsExact identifier
application number: M018
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
application number: M018
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
application number: M018
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
application number: M018
OHTrust Artifical EyedropSODIUM CHLORIDENanoplus Technology Co., Limited2ea26d96-704b-17bb-e063-6394a90a7e272026-07-01WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
application number: M018
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
application number: M018
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
application number: M018
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
application number: M018
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUM 0.5%CARDINAL HEALTH 110, LLC. DBA LEADER51a2d74f-5ff3-9921-e063-6294a90a345a2026-06-15WarningsExact identifier
application number: M018

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