TopCare Health Advanced Moisturizing Plus Redness Relief

Product NDC
36800-856
11-digit product format
368000856
Labeler code
36800
Product ID
36800-856_0cfa88e0-a3dd-180c-e063-6294a90ae2ac
Type
HUMAN OTC DRUG
Nonproprietary name
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Topco Associates LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-04
Substance
DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
.1; 1; 1; .05 g/100mL; g/100mL; g/100mL; g/100mL
Pharmacologic classes
Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [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 Health Advanced Moisturizing Plus Redness Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTRAN 70.1 g/100mL
POLYETHYLENE GLYCOL 4001 g/100mL
POVIDONE1 g/100mL
TETRAHYDROZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7SA290YK68, B697894SGQ, FZ989GH94E, 0YZT43HS7D
Rxcui996202

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-856-01TopCare Health Advanced Moisturizing Plus Redness Relief15 mL in 1 BOTTLE, DROPPERSOLUTION153
36800-856-01TopCare Health Advanced Moisturizing Plus Redness Relief1 in 1 CARTONSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-856TOPCARE HEALTH ADVANCED MOISTURIZING PLUS REDNESS RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20231221_9c6193a6-d822-1b27-e053-2995a90ab3cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN9c6193a6-d822-1b27-e053-2995a90ab3cf3
996202dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD9c6193a6-d822-1b27-e053-2995a90ab3cf3
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionSY9c6193a6-d822-1b27-e053-2995a90ab3cf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-856-01368000856011 BOTTLE, DROPPER in 1 CARTON (36800-856-01) / 15 mL in 1 BOTTLE, DROPPER2020-02-040000-00-00NoNoCurrent