Fexofenadine hydrochloride

Product NDC
55910-111
11-digit product format
559100111
Labeler code
55910
Product ID
55910-111_70e933f5-e72a-663c-784c-2eb38e453301
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Dollar General
Application
ANDA076502
Marketing category
ANDA
Marketing start
2019-07-17
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

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2S068B75ZUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
997420Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b2a14a1-a5cc-4f5e-8127-57e9d913f50aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-111-30Fexofenadine hydrochloride30 in 1 BOTTLETABLET307
55910-111-30Fexofenadine hydrochloride1 in 1 CARTONTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-111FEXOFENADINE HYDROCHLORIDE TABLET [DOLLAR GENERAL ]7Current NDC, Legacy NDC, 2 package rows20241114_1b2a14a1-a5cc-4f5e-8127-57e9d913f50a.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
ndc (product): 55910-111
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 TabletPSN1b2a14a1-a5cc-4f5e-8127-57e9d913f50a7
997420fexofenadine hydrochloride 180 MG Oral TabletSCD1b2a14a1-a5cc-4f5e-8127-57e9d913f50a7
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY1b2a14a1-a5cc-4f5e-8127-57e9d913f50a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-111-30559100111301 BOTTLE in 1 CARTON (55910-111-30) / 30 TABLET in 1 BOTTLE1 bottle2019-07-170000-00-00NoNoCurrent