FDA.reportPublic FDA data

allergy relief

Product NDC
37808-583
11-digit product format
378080583
Labeler code
37808
Product ID
37808-583_1a0c9fbb-a868-403b-9a25-76ee938ce754
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H E B
Application
ANDA078336
Marketing category
ANDA
Marketing start
2018-01-26
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
allergy relief
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
37808-583-06allergy relief1 in 1 CARTONTABLET, FILM COATED14
37808-583-06allergy relief70 in 1 BOTTLETABLET, FILM COATED704
37808-583-39allergy relief30 in 1 BOTTLETABLET, FILM COATED304
37808-583-39allergy relief1 in 1 CARTONTABLET, FILM COATED14
37808-583-58allergy relief40 in 1 BOTTLETABLET, FILM COATED404
37808-583-58allergy relief1 in 1 CARTONTABLET, FILM COATED14
37808-583-66allergy relief1 in 1 BLISTER PACKTABLET, FILM COATED14
37808-583-66allergy relief14 in 1 CARTONTABLET, FILM COATED144
37808-583-76allergy relief120 in 1 BOTTLETABLET, FILM COATED1204
37808-583-76allergy relief1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-583ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]3Current NDC, Legacy NDC, 10 package rows20201016_8649fc1e-ad56-4660-bbbb-8f1ed795697b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN8649fc1e-ad56-4660-bbbb-8f1ed795697b4
1014678cetirizine hydrochloride 10 MG Oral TabletSCD8649fc1e-ad56-4660-bbbb-8f1ed795697b4
1014678cetirizine HCl 10 MG Oral TabletSY8649fc1e-ad56-4660-bbbb-8f1ed795697b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-583-06378080583061 BOTTLE in 1 CARTON (37808-583-06) / 70 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-01-260000-00-00NoNoCurrent
37808-583-39378080583391 BOTTLE in 1 CARTON (37808-583-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-01-260000-00-00NoNoCurrent
37808-583-58378080583581 BOTTLE in 1 CARTON (37808-583-58) > 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-01-260000-00-00NoNoCurrent
37808-583-663780805836614 BLISTER PACK in 1 CARTON (37808-583-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2018-01-260000-00-00NoNoCurrent
37808-583-76378080583761 BOTTLE in 1 CARTON (37808-583-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-01-260000-00-00NoNoCurrent