Topcare Maximum Redness Relief Eye Drops

Product NDC
36800-975
11-digit product format
368000975
Labeler code
36800
Product ID
36800-975_0cfa9846-2cd8-d0fc-e063-6394a90af06b
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, naphazoline hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Topco Assoc LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-04
Substance
GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
Active strength
.5; .03 g/100mL; g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Maximum Redness Relief Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN.5 g/100mL
NAPHAZOLINE HYDROCHLORIDE.03 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX, MZ1131787D
Rxcui1235200

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-975-01Topcare Maximum Redness Relief Eye Drops1 in 1 CARTONSOLUTION13
36800-975-01Topcare Maximum Redness Relief Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-975TOPCARE MAXIMUM REDNESS RELIEF EYE DROPS (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE) SOLUTION [TOPCO ASSOC LLC]3Current NDC, Legacy NDC, 2 package rows20231221_9c6193a6-d824-1b27-e053-2995a90ab3cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235200glycerin 0.5 % / naphazoline HCl 0.03 % Ophthalmic SolutionPSN9c6193a6-d824-1b27-e053-2995a90ab3cf3
1235200glycerin 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic SolutionSCD9c6193a6-d824-1b27-e053-2995a90ab3cf3
1235200glycerin 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic SolutionSY9c6193a6-d824-1b27-e053-2995a90ab3cf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-975-01368000975011 BOTTLE, DROPPER in 1 CARTON (36800-975-01) / 15 mL in 1 BOTTLE, DROPPER2020-02-040000-00-00NoNoCurrent