FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Product NDC
71205-739
11-digit product format
712050739
Labeler code
71205
Product ID
71205-739_4a9b4b7f-0441-44d3-86c7-2542ef4b119a
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA212971
Marketing category
ANDA
Marketing start
2022-01-07
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212971-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24
A212971-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24

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 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-2484e616aacf4f…
2026-09-14 22:38:342026-08A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-2484e616aacf4f…
2026-08-18 06:07:402026-07A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24caaa826d4ba7…
2026-08-18 06:07:402026-07A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-244b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24bb7c543d1eb4…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine Hydrochloride
Listing expiration
2027-12-31

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
4a9b4b7f-0441-44d3-86c7-2542ef4b119aAvailable on FDA.report

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
71205-739-30Fexofenadine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
71205-739-60Fexofenadine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
71205-739-90Fexofenadine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-739-60EA - Each71205-7390463b2a6-ddcf-4492-b2e1-eca728128b1012023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-739FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20230106_4a9b4b7f-0441-44d3-86c7-2542ef4b119a.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALLERGYFEXOFENADINE HYDROCHLORIDEAmazon.com Services LLC1b5aa481-205d-4935-ae58-fcb8cbc35c4c2026-09-09WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
dg health aller easeFEXOFENADINE HYDROCHLORIDEDolgencorp Incf9239aa4-b3d0-4817-b639-61ad1383f7072026-08-05WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
HIVES RELIEFFEXOFENADINE HYDROCHLORIDEWalgreen Companya79edb5d-02d9-4c53-9509-c69fd61156862026-07-22WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
Allergy ReliefFEXOFENADINE HYDROCHLORIDEKroger Company2718d6a2-0678-4703-9a5a-26b27d7539422026-07-20WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
careone allergy reliefFEXOFENADINE HYDROCHLORIDERetail Business Services, LLCce398856-e9a6-401d-8636-bc5771a7e28b2026-04-14WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
allergy reliefFEXOFENADINE HYDROCHLORIDEHyVee Inc54635220-dd44-4baa-b929-9e52deb4c3682026-03-25WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
berkley jensen allergy reliefFEXOFENADINE HYDROCHLORIDEBJWC2c6d9f8c-bc74-4e1a-bd51-50f84ab63a152026-02-06WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
Allergy ReliefFEXOFENADINE HYDROCHLORIDECVS Pharmacy7cac266a-4de8-4af1-8324-b01823a3989a2026-01-07WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
topcare allergy reliefFEXOFENADINE HYDROCHLORIDETopco Associates LLCe7658b5f-2d78-4f25-b1a3-e49198ca8f322025-12-22WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
good sense aller easeFEXOFENADINE HYDROCHLORIDEL. Perrigo Companye533a008-b437-401e-ab50-bda31e6662d32025-10-09WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
up and up non drowsy allergy reliefFEXOFENADINE HYDROCHLORIDETarget Corporationd251b0a6-bc31-45b6-aaa8-f50f8336d9592025-08-19WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
exchange select aller easeFEXOFENADINE HYDROCHLORIDEArmy & Air Force Exchange Service6a9597a1-f024-4497-bc52-3d54827588222025-04-03WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
Leader 24HR Allergy ReliefFEXOFENADINE HYDROCHLORIDECardinal Health 110, LLC. dba Leadere509800a-e33d-4d22-a6b4-97b7c73b14862025-04-01WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
Allergy ReliefFEXOFENADINE HYDROCHLORIDEWalgreen Company99f03481-d169-4aac-8370-20011ff530ea2024-12-13WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
allergy reliefFEXOFENADINE HYDROCHLORIDEMeijer, Inc.deecbf76-be1d-4b27-85c6-17cfb7e7d1a12024-07-25WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
basic care allergyFEXOFENADINE HYDROCHLORIDEAmazon.com Services LLCc2f30390-3d32-4489-9df2-caf848ce040b2024-07-17WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
Basic Care AllergyFEXOFENADINE HYDROCHLORIDEAmazon.com Services LLC27202f58-a488-42cc-b63f-be892c5b4de22024-05-10WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
Basic Care AllergyFEXOFENADINE HYDROCHLORIDEAmazon.com Services LLCc29d281f-89dd-4c69-8572-6599400c660f2024-04-22WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
allergy reliefFEXOFENADINE HYDROCHLORIDEWalgreen Companya0738300-7262-4e43-89a6-0d0a60bd14bd2024-02-14WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
kirkland signature aller fexFEXOFENADINE HYDROCHLORIDECostco Wholesale Company651d14d1-c5de-4cb9-9484-b05986e641ac2023-05-02WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN4a9b4b7f-0441-44d3-86c7-2542ef4b119a1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD4a9b4b7f-0441-44d3-86c7-2542ef4b119a1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY4a9b4b7f-0441-44d3-86c7-2542ef4b119a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-739-307120507393030 TABLET, FILM COATED in 1 BOTTLE (71205-739-30) 2022-12-280000-00-00NoNoCurrent
71205-739-607120507396060 TABLET, FILM COATED in 1 BOTTLE (71205-739-60) 2022-12-280000-00-00NoNoCurrent
71205-739-907120507399090 TABLET, FILM COATED in 1 BOTTLE (71205-739-90) 2022-12-280000-00-00NoNoCurrent