FDA.reportPublic FDA data

topcare all day allergy

Product NDC
36800-448
11-digit product format
368000448
Labeler code
36800
Product ID
36800-448_eb748140-aec8-4fcf-9597-20610d87635a
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA213105
Marketing category
ANDA
Marketing start
2022-02-28
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 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
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014675

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-448-09topcare all day allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED13
36800-448-09topcare all day allergy65 in 1 BOTTLECAPSULE, LIQUID FILLED653
36800-448-49topcare all day allergy40 in 1 BOTTLECAPSULE, LIQUID FILLED403
36800-448-49topcare all day allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED13
36800-448-63topcare all day allergy25 in 1 BOTTLECAPSULE, LIQUID FILLED253
36800-448-63topcare all day allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-448TOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 6 package rows20230314_10c512a1-bb96-4d2a-9e41-a422efb57e28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN10c512a1-bb96-4d2a-9e41-a422efb57e283
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD10c512a1-bb96-4d2a-9e41-a422efb57e283
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY10c512a1-bb96-4d2a-9e41-a422efb57e283

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-448-09368000448091 BOTTLE in 1 PACKAGE (36800-448-09) / 65 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-02-280000-00-00NoNoCurrent
36800-448-49368000448491 BOTTLE in 1 PACKAGE (36800-448-49) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2023-02-03NoNoCurrent
36800-448-63368000448631 BOTTLE in 1 PACKAGE (36800-448-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-02-280000-00-00NoNoCurrent