FDA.reportPublic FDA data

HEB

Product NDC
37808-102
11-digit product format
378080102
Labeler code
37808
Product ID
37808-102_44787388-9e5a-cc35-e063-6394a90a1072
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
H E B
Application
ANDA090182
Marketing category
ANDA
Marketing start
2011-09-08
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
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
HEB
Brand name suffix
Allergy Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-102-082025-11-26C16284748780-13b156c62-2d81-fb37-e063-e6dba90a4e07HEB ® Allergy Relief
37808-102-082025-11-26C16284748780-13b156c62-2d81-fb37-e063-e6dba90a4e07HEB ® Allergy Relief
37808-102-082025-07-29C16284748780-13b156c62-2d81-fb37-e063-e6dba90a4e07HEB ® Allergy Relief
37808-102-082025-07-29C16284748780-13b156c62-2d81-fb37-e063-e6dba90a4e07HEB ® Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-102-08HEB Allergy Relief1 in 1 CARTONSOLUTION14
37808-102-08HEB Allergy Relief120 mL in 1 BOTTLESOLUTION1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37808-102-08ML - Milliliter37808-1021e335287-78ed-41b2-8463-fd1e8570981012022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOAHEB ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [H E B]2
CetirizineACTIVE MOIETYYO7261ME24HEB ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [H E B]2
acetic acidINACTIVE INGREDIENTQ40Q9N063PHEB ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [H E B]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXHEB ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [H E B]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9THEB ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [H E B]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3HEB ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [H E B]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHHEB ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [H E B]2
sodium acetate anhydrousINACTIVE INGREDIENTNVG71ZZ7P0HEB ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [H E B]2
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4HEB ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [H E B]2
waterINACTIVE INGREDIENT059QF0KO0RHEB ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [H E B]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-102HEB ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [H E B]3Current NDC, Legacy NDC, 2 package rows20180516_9abdae64-4c3d-47f3-8224-fc81f7bfe557.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN9abdae64-4c3d-47f3-8224-fc81f7bfe5574
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD9abdae64-4c3d-47f3-8224-fc81f7bfe5574
1014673cetirizine HCl 1 MG/ML Oral SyrupSY9abdae64-4c3d-47f3-8224-fc81f7bfe5574
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY9abdae64-4c3d-47f3-8224-fc81f7bfe5574

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-102-08378080102081 BOTTLE in 1 CARTON (37808-102-08) / 120 mL in 1 BOTTLE1 bottle2018-04-240000-00-00NoNoCurrent