Cetirizine hydrochloride

Product NDC
70692-139
11-digit product format
706920139
Labeler code
70692
Product ID
70692-139_b451c631-6bdc-d42e-e053-2995a90af099
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Strive Pharmaceuticals Inc
Application
ANDA209274
Marketing category
ANDA
Marketing start
2020-07-01
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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209274-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2017-12-22

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEStrive Pharmaceuticals Inca4ebeec7-0245-4f77-e053-2995a90a7e7f2020-11-17WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product ■ drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

Additional Listing Data#

Finished product
Yes
Brand name base
Cetirizine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-139-14Cetirizine hydrochloride14 in 1 BOTTLETABLET142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-139CETIRIZINE HYDROCHLORIDE TABLET [STRIVE PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 1 package rows20201118_a4ebeec7-0245-4f77-e053-2995a90a7e7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNa4ebeec7-0245-4f77-e053-2995a90a7e7f2
1014678cetirizine hydrochloride 10 MG Oral TabletSCDa4ebeec7-0245-4f77-e053-2995a90a7e7f2
1014678cetirizine HCl 10 MG Oral TabletSYa4ebeec7-0245-4f77-e053-2995a90a7e7f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70692-139-147069201391414 TABLET in 1 BOTTLE (70692-139-14) 14 tablet2020-07-010000-00-00NoNoCurrent