FDA.reportPublic FDA data

Cetirizine HCl

Product NDC
36800-542
11-digit product format
368000542
Labeler code
36800
Product ID
36800-542_27895955-45c0-4a92-e063-6394a90a01cf
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
NDA022429
Marketing category
NDA
Marketing start
2024-11-22
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
Cetirizine HCl
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
36800-542-15Cetirizine HCl40 in 1 BOTTLE, PLASTICCAPSULE402
36800-542-15Cetirizine HCl1 in 1 PACKAGECAPSULE12
36800-542-86Cetirizine HCl1 in 1 PACKAGECAPSULE12
36800-542-86Cetirizine HCl25 in 1 BOTTLE, PLASTICCAPSULE252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-542CETIRIZINE HCL CAPSULE [TOP CARE (TOPCO ASSOCIATES LLC)]2Current NDC, 4 package rows20241124_2033e2c3-81af-b1cf-e063-6394a90adbc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN2033e2c3-81af-b1cf-e063-6394a90adbc52
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD2033e2c3-81af-b1cf-e063-6394a90adbc52
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY2033e2c3-81af-b1cf-e063-6394a90adbc52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
36800-542-15368000542151 BOTTLE, PLASTIC in 1 PACKAGE (36800-542-15) / 40 CAPSULE in 1 BOTTLE, PLASTIC2024-11-22NoNoHistorical
36800-542-86368000542861 BOTTLE, PLASTIC in 1 PACKAGE (36800-542-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC2024-11-22NoNoHistorical