FDA.reportPublic FDA data

Rohto Optic Glow

Product NDC
10742-8160
11-digit product format
107428160
Labeler code
10742
Product ID
10742-8160_2978fba5-0be6-3179-e063-6294a90a182a
Type
HUMAN OTC DRUG
Nonproprietary name
Naphazoline hydrochloride, Povidone, Propylene glycol
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
The Mentholatum Company
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-26
Substance
NAPHAZOLINE HYDROCHLORIDE; POVIDONE, UNSPECIFIED; PROPYLENE GLYCOL
Active strength
.3; 5; 2 mg/mL; 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 Optic Glow
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPHAZOLINE HYDROCHLORIDE.3 mg/mL
POVIDONE, UNSPECIFIED5 mg/mL
PROPYLENE GLYCOL2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMZ1131787D, FZ989GH94E, 6DC9Q167V3
Rxcui2531299

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8160-1Rohto Optic Glow1 in 1 CARTONLIQUID17
10742-8160-1Rohto Optic Glow13 mL in 1 BOTTLE, WITH APPLICATORLIQUID137

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8160ROHTO OPTIC GLOW (NAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOL) LIQUID [THE MENTHOLATUM COMPANY]7Current NDC, Legacy NDC, 2 package rows20241219_df9c5f7c-96e6-4b2b-b8cb-21a6a3342dff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2531299naphazoline hydrochloride 0.03 % / povidone 0.5 % / propylene glycol 0.2 % Ophthalmic SolutionPSNdf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff7
2531299naphazoline hydrochloride 0.3 MG/ML / povidone 5 MG/ML / propylene glycol 2 MG/ML Ophthalmic SolutionSCDdf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff7
2531299naphazoline hydrochloride 0.03 % / povidone 0.5 % / propylene glycol 0.2 % Ophthalmic SolutionSYdf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10742-8160-1107428160011 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8160-1) / 13 mL in 1 BOTTLE, WITH APPLICATOR2021-03-260000-00-00NoNoCurrent