FDA.reportPublic FDA data

Rohto Dry-Aid

Product NDC
10742-8162
Requested package NDC
10742-8162-1
11-digit product format
107428162
Labeler code
10742
Product ID
10742-8162_59588453-9990-ef56-e063-6394a90a7e4a
Type
HUMAN OTC DRUG
Nonproprietary name
povidone, propylene glycol
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
The Mentholatum Company
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-01
Substance
POVIDONE, UNSPECIFIED; PROPYLENE GLYCOL
Active strength
6.8; 3 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 Dry-Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE, UNSPECIFIED6.8 mg/mL
PROPYLENE GLYCOL3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FZ989GH94EInternal UNII lookup
6DC9Q167V3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1863574Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ea5c6c9-48f4-406a-a2cb-9280c546d87dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
10742-8162-12023-02-07Drug Facts - Rohto Dry-Aid
10742-8162-12023-02-07Drug Facts - Rohto Dry-Aid
10742-8162-22023-02-07Drug Facts - Rohto Dry-Aid
10742-8162-22023-02-07Drug Facts - Rohto Dry-Aid
10742-8162-12023-01-30Drug Facts - Rohto Dry-Aid
10742-8162-12023-01-30Drug Facts - Rohto Dry-Aid
10742-8162-22023-01-30Drug Facts - Rohto Dry-Aid
10742-8162-22023-01-30Drug Facts - Rohto Dry-Aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8162-1Rohto Dry-Aid10 mL in 1 BOTTLE, DROPPERLIQUID1010
10742-8162-1Rohto Dry-Aid1 in 1 CARTONLIQUID110
10742-8162-2Rohto Dry-Aid2 in 1 CARTONLIQUID210
10742-8162-2Rohto Dry-Aid10 mL in 1 BOTTLE, DROPPERLIQUID1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8162ROHTO DRY-AID (POVIDONE, PROPYLENE GLYCOL) LIQUID [THE MENTHOLATUM COMPANY]10Current NDC, Legacy NDC, 4 package rows20241219_8ea5c6c9-48f4-406a-a2cb-9280c546d87d.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
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
ndc (package): 10742-8162-1
ndc (product): 10742-8162
ndc11 (package): 10742816201
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
1863574povidone 0.68 % / propylene glycol 0.3 % Opthalmic SolutionPSN8ea5c6c9-48f4-406a-a2cb-9280c546d87d10
1863574povidone 6.8 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD8ea5c6c9-48f4-406a-a2cb-9280c546d87d10
1863574povidone 0.68 % / propylene glycol 0.3 % Opthalmic SolutionSY8ea5c6c9-48f4-406a-a2cb-9280c546d87d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10742-8162-1107428162011 BOTTLE, DROPPER in 1 CARTON (10742-8162-1) / 10 mL in 1 BOTTLE, DROPPER2017-01-010000-00-00NoNoCurrent