Allergy Relief

Product NDC
46122-462
Requested package NDC
46122-462-65
11-digit product format
461220462
Labeler code
46122
Product ID
46122-462_e953eab7-ca21-0d52-9ddc-25b3c0720afb
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AMERISOURCEBERGEN DRUG CORPORATION
Application
ANDA076502
Marketing category
ANDA
Marketing start
2018-02-20
Marketing end
2026-07-31
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage46122-46246122-462-65DDiscontinued by firm2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076502-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2006-04-11
A076502-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2006-04-11
A076502-003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2006-04-11
A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-12
A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-12
A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-12
A076502-007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-12
A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-04-12
A076502-009FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-04-12

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.

Product history page 1 of 10 · 369 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-12b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076502-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076502-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076502-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076502-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076502-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076502-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076502-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076502-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076502-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076502-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076502-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076502-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076502-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076502-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076502-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076502-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076502-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076502-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076502-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076502-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076502-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076502-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076502-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076502-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076502-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076502-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076502-001AB18072bd15b7f6…

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
46122-462-22Allergy Relief3 in 1 CARTONTABLET35
46122-462-22Allergy Relief5 in 1 BLISTER PACKTABLET55
46122-462-61Allergy Relief45 in 1 BOTTLETABLET455
46122-462-61Allergy Relief1 in 1 CARTONTABLET15
46122-462-65Allergy Relief30 in 1 BOTTLETABLET305
46122-462-65Allergy Relief1 in 1 CARTONTABLET15
46122-462-75Allergy Relief1 in 1 CARTONTABLET15
46122-462-75Allergy Relief90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-462-22EA - Each46122-462841baaae-91fe-45d1-8dfb-e077aca263b612020-04-20
46122-462-61EA - Each46122-4625d805f13-67a6-4f7a-97f5-13cd9188485612020-04-20
46122-462-65EA - Each46122-46243cafefd-f84e-4b54-8845-4244f20ebeee12020-01-03
46122-462-75EA - Each46122-4625a05e174-8d1d-42e5-b8c3-0853940c0ff512020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-462ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [AMERISOURCEBERGEN DRUG CORPORATION]4Current NDC, Legacy NDC, 8 package rows20230628_cafb5240-6bc1-1bf5-f12f-00d9502d75fe.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEBluePoint Laboratoriesa86aebd0-937e-5d73-e053-2995a90a656a2026-07-13WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Limited864e3052-5787-bf11-9d17-11274ca2304f2026-07-09WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.b0121213-eae1-8429-9986-3b3b26f35e472026-07-09WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Non-Drowsy Allergy ReliefFEXOFENADINE HYDROCHLORIDETARGET CORPORATION3cf4b7fe-b1f7-b767-430a-655408f917532025-08-01WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEMAJOR PHARMACEUTICALS0a6da401-a8a3-5d0b-f37e-c220838f7e492025-07-27WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEWalgreens Companyb961985e-0c18-b36f-d82e-32ff2d46fada2025-07-18WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDollar General1b2a14a1-a5cc-4f5e-8127-57e9d913f50a2024-11-12WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEKROGER COMPANY7b146260-c925-3238-d092-24b7101ceb502024-11-12WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.624b3a91-af4f-8848-6fc3-392e0df34cc82024-11-12WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDECVS Health Corp.204506d7-7688-fd7e-0aae-142b698848ef2024-11-12WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEStrategic Sourcing Services, LLCde438313-9790-b4ea-2d28-7a19836cf5e22023-04-21WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Allergy ReliefFEXOFENADINE HYDROCHLORIDERite Aid Corporationaf2ef0bf-6cd2-b9a6-ff8f-6f50aac152ce2022-06-12WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Wal-FexFEXOFENADINE HYDROCHLORIDEWalgreens Company95d420ea-6337-304f-54c3-0c75be1608e22022-01-22WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Allergy ReliefFEXOFENADINE HYDROCHLORIDEFamily Dollar Stores, Inc.f532e9d5-6457-8bef-e83e-16050f20b03c2020-02-19WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDESam's West Inc.1c1f43c4-7128-37c4-83fe-7eefac3fd4772019-10-07WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Allergy ReliefFEXOFENADINE HYDROCHLORIDESafeway Inc3c30a1dc-a13d-2522-d4d0-00c1e9dbab072017-12-11WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEChain Drug Consortium, LLCd1d8d0ec-2bdd-fb07-a051-d6353e3c240c2014-01-22WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEChain Drug Marketing Associate8a1de8a1-808a-bc08-6c74-957d6f388eab2014-01-22WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNcafb5240-6bc1-1bf5-f12f-00d9502d75fe5
997420fexofenadine hydrochloride 180 MG Oral TabletSCDcafb5240-6bc1-1bf5-f12f-00d9502d75fe5
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYcafb5240-6bc1-1bf5-f12f-00d9502d75fe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-462-65461220462651 BOTTLE in 1 CARTON (46122-462-65) > 30 TABLET in 1 BOTTLE1 bottle2018-02-200000-00-00NoNoCurrent