FDA.reportPublic FDA data

Rohto

Product NDC
10742-8158
Requested package NDC
10742-8158-1
11-digit product format
107428158
Labeler code
10742
Product ID
10742-8158_597624b2-ba16-52c5-e063-6294a90a5ee3
Type
HUMAN OTC DRUG
Nonproprietary name
Naphazoline hydrochloride, Polysorbate 80
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
The Mentholatum Company
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-12
Substance
NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80
Active strength
.3; 2 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Rohto
Brand name suffix
Max Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPHAZOLINE HYDROCHLORIDE.3 mg/mL
POLYSORBATE 802 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MZ1131787DInternal UNII lookup
6OZP39ZG8HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1535485Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e4b49550-1ca3-4bd7-854d-409b53fa5e26Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
10742-8158-12023-02-08Drug Facts
10742-8158-12023-02-08Drug Facts
10742-8158-12023-02-08Drug Facts
10742-8158-22023-02-08Drug Facts
10742-8158-22023-02-08Drug Facts
10742-8158-22023-02-08Drug Facts
10742-8158-12023-01-30Drug Facts
10742-8158-12023-01-30Drug Facts
10742-8158-12023-01-30Drug Facts
10742-8158-22023-01-30Drug Facts
10742-8158-22023-01-30Drug Facts
10742-8158-22023-01-30Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8158-1RohtoMax Strength1 in 1 CARTONLIQUID14
10742-8158-1RohtoMax Strength13 mL in 1 BOTTLE, WITH APPLICATORLIQUID134
10742-8158-2RohtoMax Strength13 mL in 1 BOTTLE, WITH APPLICATORLIQUID134
10742-8158-2RohtoMax Strength2 in 1 CARTONLIQUID24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8158ROHTO MAX STRENGTH (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]4Current NDC, Legacy NDC, 4 package rows20241219_e4b49550-1ca3-4bd7-854d-409b53fa5e26.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 25 · 499 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
application number: M018
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
application number: M018
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
application number: M018
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
application number: M018
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
application number: M018
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
application number: M018
REFRESH LIQUIGELCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.4b8b2f6a-4b89-446c-9e5b-9b83c453a01d2026-08-28WarningsExact identifier
application number: M018
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
application number: M018
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
application number: M018
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
application number: M018
ndc (package): 10742-8158-1
ndc (product): 10742-8158
ndc11 (package): 10742815801
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
application number: M018
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5967ef02-6770-bfd7-e063-6294a90a79042026-08-19WarningsExact identifier
application number: M018
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
application number: M018
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
application number: M018
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
application number: M018
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5905b300-6f1f-a61f-e063-6394a90a11232026-08-14WarningsExact identifier
application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
application number: M018
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
application number: M018
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
application number: M018
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1535485naphazoline HCl 0.03 % / polysorbate 80 0.2 % Ophthalmic SolutionPSNe4b49550-1ca3-4bd7-854d-409b53fa5e264
1535485naphazoline hydrochloride 0.3 MG/ML / polysorbate 80 2 MG/ML Ophthalmic SolutionSCDe4b49550-1ca3-4bd7-854d-409b53fa5e264
1535485naphazoline HCl 0.03 % / polysorbate 80 0.2 % Ophthalmic SolutionSYe4b49550-1ca3-4bd7-854d-409b53fa5e264

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10742-8158-1107428158011 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8158-1) / 13 mL in 1 BOTTLE, WITH APPLICATOR2021-05-120000-00-00NoNoCurrent