FDA.reportPublic FDA data

Rohto

Product NDC
10742-8142
11-digit product format
107428142
Labeler code
10742
Product ID
10742-8142_177c76f0-90d8-4ac1-aee1-b4f181e8df3d
Type
HUMAN OTC DRUG
Nonproprietary name
Naphazoline hydrochloride, Polysorbate 80
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
The Mentholatum Company
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2001-08-21
Marketing end
0000-00-00
Substance
NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80
Active strength
0 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10742-8142DDiscontinued by firm2026-10-05
excluded packagepackage10742-814210742-8142-1DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8142-12023-02-08C16284748780-1f386c64a-3d8e-0266-e053-dadaa90a7c1aDrug Facts
10742-8142-12023-01-30C16284748780-1f386c64a-3d8e-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8142-1RohtoCool1 in 1 CARTONLIQUID115
10742-8142-1RohtoCool13 mL in 1 BOTTLE, WITH APPLICATORLIQUID1315

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPHAZOLINE HYDROCHLORIDEACTIVE INGREDIENTMZ1131787DROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]6
POLYSORBATE 80ACTIVE INGREDIENT6OZP39ZG8HROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]6
NAPHAZOLINEACTIVE MOIETYH231GF11BVROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]6
POLYSORBATE 80ACTIVE MOIETY6OZP39ZG8HROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]6
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]6
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]6
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]6
MENTHOLINACTIVE INGREDIENTL7T10EIP3AROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]6
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]6
WATERINACTIVE INGREDIENT059QF0KO0RROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8142ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]15Legacy NDC, 2 package rows20241219_69166dec-fb86-4c76-9efe-88c3bb12a8f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098362naphazoline HCl 0.012 % / polysorbate 80 0.2 % Ophthalmic SolutionPSN69166dec-fb86-4c76-9efe-88c3bb12a8f015
1098362naphazoline hydrochloride 0.12 MG/ML / polysorbate 80 2 MG/ML Ophthalmic SolutionSCD69166dec-fb86-4c76-9efe-88c3bb12a8f015
1098362naphazoline hydrochloride 0.012 % / polysorbate 80 0.2 % Ophthalmic SolutionSY69166dec-fb86-4c76-9efe-88c3bb12a8f015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10742-8142-1107428142011 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8142-1) > 13 mL in 1 BOTTLE, WITH APPLICATOR2001-08-210000-00-00NoNoCurrent