Topcare All Day Allergy

Product NDC
36800-241
11-digit product format
368000241
Labeler code
36800
Product ID
36800-241_e685d7d8-ba5f-424a-9a98-54bde72bfacf
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA211983
Marketing category
ANDA
Marketing start
2020-02-05
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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 All Day Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOCETIRIZINE DIHYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOD6A38AGA
Rxcui855172

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-241-01Topcare All Day Allergy35 in 1 BOTTLETABLET, FILM COATED354
36800-241-01Topcare All Day Allergy1 in 1 CARTONTABLET, FILM COATED14
36800-241-46Topcare All Day Allergy10 in 1 CARTONTABLET, FILM COATED104
36800-241-46Topcare All Day Allergy1 in 1 BLISTER PACKTABLET, FILM COATED14
36800-241-95Topcare All Day Allergy45 in 1 BOTTLETABLET, FILM COATED454
36800-241-95Topcare All Day Allergy1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-241TOPCARE ALL DAY ALLERGY (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 6 package rows20220305_393616df-52f1-4e77-b69c-8239ca193d5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN393616df-52f1-4e77-b69c-8239ca193d5b4
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD393616df-52f1-4e77-b69c-8239ca193d5b4
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY393616df-52f1-4e77-b69c-8239ca193d5b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-241-01368000241011 BOTTLE in 1 CARTON (36800-241-01) / 35 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-02-050000-00-00NoNoCurrent
36800-241-463680002414610 BLISTER PACK in 1 CARTON (36800-241-46) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2020-03-090000-00-00NoNoCurrent
36800-241-95368000241951 BOTTLE in 1 CARTON (36800-241-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-10-070000-00-00NoNoCurrent