FDA.reportPublic FDA data

Allergy Relief

Product NDC
69842-704
Requested package NDC
69842-704-70
11-digit product format
698420704
Labeler code
69842
Product ID
69842-704_16c67165-aacb-4f32-b65b-949261ac97de
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA079112
Marketing category
ANDA
Marketing start
2017-10-31
Marketing end
2025-05-30
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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69842-70469842-704-70DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2012-02-08
A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2012-02-08
A079112-003FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2012-02-08
A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2012-02-08
A079112-005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2012-02-08
A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2012-02-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-08a50c72e98297…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-704ALLERGY RELIEF (FEXOFENADINE HCL) TABLET, COATED [CVS PHARMACY]3Legacy NDC20221201_5b11cafe-f000-4e25-b2d0-a7297890b7f3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-704-70698420704701 BOTTLE, PLASTIC in 1 BOX (69842-704-70) > 30 TABLET, COATED in 1 BOTTLE, PLASTIC2017-10-312025-05-30NoNoCurrent