FDA.reportPublic FDA data

Rohto

Product NDC
10742-8159
11-digit product format
107428159
Labeler code
10742
Product ID
10742-8159_2978d571-17d3-2c20-e063-6394a90a14cd
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
2014-05-05
Substance
NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80
Active strength
.3; 2 mg/mL; mg/mL
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
Cool Max
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMZ1131787D, 6OZP39ZG8H
Rxcui1535485

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
10742-8159-12023-02-08C16284748780-1f386c649-acc3-0266-e053-dadaa90a7c1aDrug Facts - Rohto Cool Max
10742-8159-12023-01-30C16284748780-1f386c649-acc3-0266-e053-dadaa90a7c1aDrug Facts - Rohto Cool Max

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8159-1RohtoCool Max1 in 1 CARTONLIQUID19
10742-8159-1RohtoCool Max13 mL in 1 BOTTLE, WITH APPLICATORLIQUID139

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPHAZOLINE HYDROCHLORIDEACTIVE INGREDIENTMZ1131787DROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]2
POLYSORBATE 80ACTIVE INGREDIENT6OZP39ZG8HROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]2
NAPHAZOLINEACTIVE MOIETYH231GF11BVROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]2
POLYSORBATE 80ACTIVE MOIETY6OZP39ZG8HROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4ROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]2
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3AROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]2
POTASSIUM ASPARTATEINACTIVE INGREDIENTOC4598NZEQROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8159ROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]9Current NDC, Legacy NDC, 2 package rows20241219_20b934af-fe24-44a2-b313-5540a209432c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1535485naphazoline HCl 0.03 % / polysorbate 80 0.2 % Ophthalmic SolutionPSN20b934af-fe24-44a2-b313-5540a209432c9
1535485naphazoline hydrochloride 0.3 MG/ML / polysorbate 80 2 MG/ML Ophthalmic SolutionSCD20b934af-fe24-44a2-b313-5540a209432c9
1535485naphazoline HCl 0.03 % / polysorbate 80 0.2 % Ophthalmic SolutionSY20b934af-fe24-44a2-b313-5540a209432c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10742-8159-1107428159011 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8159-1) / 13 mL in 1 BOTTLE, WITH APPLICATOR2014-05-050000-00-00NoNoCurrent