FDA.reportPublic FDA data

equate allergy relief

Product NDC
49035-366
11-digit product format
490350366
Labeler code
49035
Product ID
49035-366_2d7ebfda-bfb1-b961-e063-6394a90a241f
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Walmart Inc.
Application
ANDA204097
Marketing category
ANDA
Marketing start
2011-04-14
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
equate 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-366-02equate allergy relief1 in 1 CARTONTABLET16
49035-366-02equate allergy relief120 in 1 BOTTLETABLET1206
49035-366-54equate allergy relief1 in 1 CARTONTABLET16
49035-366-54equate allergy relief30 in 1 BOTTLETABLET306
49035-366-59equate allergy relief2 in 1 CARTONTABLET26
49035-366-59equate allergy relief30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-366-02EA - Each49035-366b306f499-769c-4cc2-9f5c-08a17cd067d512024-09-09
49035-366-54EA - Each49035-366f0775960-d51d-4162-b991-eade7b8e8f8d12023-09-05
49035-366-59EA - Each49035-366d9380566-b2f2-4bc1-989d-be87655c6f9812024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-366EQUATE ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WALMART INC.]6Current NDC, Legacy NDC, 6 package rows20250413_852c8ad2-fc7d-4728-b2c6-f64b960fe2ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN852c8ad2-fc7d-4728-b2c6-f64b960fe2ab6
997420fexofenadine hydrochloride 180 MG Oral TabletSCD852c8ad2-fc7d-4728-b2c6-f64b960fe2ab6
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY852c8ad2-fc7d-4728-b2c6-f64b960fe2ab6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-366-02490350366021 BOTTLE in 1 CARTON (49035-366-02) / 120 TABLET in 1 BOTTLE1 bottle2011-04-140000-00-00NoNoCurrent
49035-366-54490350366541 BOTTLE in 1 CARTON (49035-366-54) / 30 TABLET in 1 BOTTLE1 bottle2011-04-140000-00-00NoNoCurrent
49035-366-59490350366592 BOTTLE in 1 CARTON (49035-366-59) / 30 TABLET in 1 BOTTLE2 bottle2011-04-140000-00-00NoNoCurrent