FDA.reportPublic FDA data

Allergy Relief

Product NDC
79903-090
11-digit product format
799030090
Labeler code
79903
Product ID
79903-090_b9559631-d448-4075-9e4b-d03f0307e85e
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET
Route
ORAL
Labeler
WALMART INC. (see also Equate)
Application
ANDA211075
Marketing category
ANDA
Marketing start
2021-10-15
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 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
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79903-090-122023-02-09C16284748780-1f386c64a-0941-0266-e053-dadaa90a7c1aDRUG FACTS
79903-090-152023-02-09C16284748780-1f386c64a-0941-0266-e053-dadaa90a7c1aDRUG FACTS
79903-090-122023-01-30C16284748780-1f386c64a-0941-0266-e053-dadaa90a7c1aDRUG FACTS
79903-090-152023-01-30C16284748780-1f386c64a-0941-0266-e053-dadaa90a7c1aDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-090-12Allergy Relief1 in 1 BOXTABLET14
79903-090-12Allergy Relief120 in 1 BOTTLE, PLASTICTABLET1204
79903-090-15Allergy Relief1 in 1 BLISTER PACKTABLET14
79903-090-15Allergy Relief15 in 1 CARTONTABLET154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79903-090-15EA - Each79903-090afbd0053-a7c5-427c-bd0f-e9e93ccbf5ec12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-090ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [WALMART INC. (SEE ALSO EQUATE)]4Current NDC, Legacy NDC, 4 package rows20230210_eb37cf76-49e2-4332-b449-1ce475556ef5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNeb37cf76-49e2-4332-b449-1ce475556ef54
997420fexofenadine hydrochloride 180 MG Oral TabletSCDeb37cf76-49e2-4332-b449-1ce475556ef54
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYeb37cf76-49e2-4332-b449-1ce475556ef54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79903-090-12799030090121 BOTTLE, PLASTIC in 1 BOX (79903-090-12) / 120 TABLET in 1 BOTTLE, PLASTIC2021-10-150000-00-00NoNoCurrent
79903-090-157990300901515 BLISTER PACK in 1 CARTON (79903-090-15) / 1 TABLET in 1 BLISTER PACK15 blister pack2021-10-150000-00-00NoNoCurrent