Cabinet Allergy Relief Fexofenadine

Product NDC
82725-3002
11-digit product format
827253002
Labeler code
82725
Product ID
82725-3002_41c5ac14-1e89-8cd8-e063-6394a90a7a43
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Cabinet Health P.B.C.
Application
ANDA211075
Marketing category
ANDA
Marketing start
2025-09-01
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 44.

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
A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2019-10-18
A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2019-10-18

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18c2088c7a36db…
2026-10-15 13:18:302026-09A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18c2088c7a36db…
2026-09-14 22:38:342026-08A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1884e616aacf4f…
2026-09-14 22:38:342026-08A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1884e616aacf4f…
2026-08-18 06:07:402026-07A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-184b0b4de00fa7…

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
Cabinet Allergy Relief Fexofenadine
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
5237c8bd-0b20-4639-a740-f3001c4c2c94Available 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
82725-3002-1Cabinet Allergy Relief Fexofenadine100 in 1 BOTTLETABLET1002
82725-3002-3Cabinet Allergy Relief Fexofenadine30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82725-3002CABINET ALLERGY RELIEF FEXOFENADINE (FEXOFENADINE HYDROCHLORIDE) TABLET [CABINET HEALTH P.B.C.]1Current NDC, 1 package rows20250406_9ed710e1-47f4-4d04-a509-12c8c97c192c.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 2 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HCLFEXOFENADINE HCLWalgreens0eaf28a5-f8dd-3888-e063-6394a90a8cc62025-12-19WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Fexofenadine HClFEXOFENADINE HCLRite Aid1dd9affe-b55d-e1fb-e063-6394a90a77942025-12-19WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Fexofenadine HClFEXOFENADINE HCLRite Aid1dda06c9-8e0f-38d7-e063-6394a90aba3e2025-12-19WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Fexofenadine HClFEXOFENADINE HCLRite Aid1ddad045-7706-ea7e-e063-6394a90a2a5a2025-12-19WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Fexofenadine HClFEXOFENADINE HCLRite Aid1ddae2a1-0e16-e294-e063-6394a90a05f52025-12-19WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Fexofenadine HClFEXOFENADINE HCLRite Aid1ddb1716-9c5b-6348-e063-6394a90acbf12025-12-19WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Cabinet Allergy Relief FexofenadineFEXOFENADINE HYDROCHLORIDECabinet Health P.B.C.9ed710e1-47f4-4d04-a509-12c8c97c192c2025-11-05WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
ndc (product): 82725-3002
ValuMeds 24-Hour Allergy ReliefFEXOFENADINE HYDROCHLORIDECabinet Health P.B.C.036f8eaa-7eb9-46f4-b42e-3c8c7e49e4502025-10-23WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Cabinet Allergy Relief FexofenadineFEXOFENADINE HYDROCHLORIDECabinet Health P.B.C.5237c8bd-0b20-4639-a740-f3001c4c2c942025-10-22WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
ndc (product): 82725-3002
Allergy ReliefFEXOFENADINE HYDROCHLORIDEFSA STORE INC.276e9767-93c0-5932-e063-6394a90ab2d92025-03-07WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Fexofenadine HCLFEXOFENADINE HCLWalgreensfd7920f6-f53e-90cf-e053-6294a90aa8db2024-12-16WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Allergy ReliefFEXOFENADINE HYDROCHLORIDEHARRIS TEETERc4f9e849-f286-4167-e053-2a95a90a38f92024-10-11WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Allergy ReliefFEXOFENADINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCc5d58d74-da08-eb72-e053-2a95a90adc272024-10-11WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Allergy ReliefFEXOFENADINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.5059ffc9-b116-4d11-9678-56c696f4e3db2024-08-16WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEGranules India Limited1d46555d-827b-b154-e063-6294a90ad3d52024-08-08WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Allergy ReliefFEXOFENADINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.c547c163-2a19-10d8-e053-2a95a90ac8172024-07-24WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Allergy ReliefFEXOFENADINE HYDROCHLORIDESafeway, Inc.348b79cf-1184-46d4-a0e5-fdc24afec1a52024-02-09WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Allergy ReliefFEXOFENADINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dc0893-b81b-4f96-e053-6294a90a856f2023-11-02WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Allergy ReliefFEXOFENADINE HYDROCHLORIDETOPCO ASSOCIATES LLCc4f9224c-4c3d-74bd-e053-2995a90a14522023-10-30WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075
Allergy ReliefFEXOFENADINE HYDROCHLORIDEChain Drug Marketing Association, Inc.fabb8c0d-b4da-ab73-e053-6394a90ab8b52023-05-22WarningsExact identifier
application applno (ANDA): 211075
application number: ANDA211075

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN5237c8bd-0b20-4639-a740-f3001c4c2c942
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN9ed710e1-47f4-4d04-a509-12c8c97c192c2
997420fexofenadine hydrochloride 180 MG Oral TabletSCD5237c8bd-0b20-4639-a740-f3001c4c2c942
997420fexofenadine hydrochloride 180 MG Oral TabletSCD9ed710e1-47f4-4d04-a509-12c8c97c192c2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY5237c8bd-0b20-4639-a740-f3001c4c2c942
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY9ed710e1-47f4-4d04-a509-12c8c97c192c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82725-3002-182725300201100 TABLET in 1 BOTTLE (82725-3002-1) 100 tablet2025-01-012027-09-01NoNoHistorical
82725-3002-38272530020330 TABLET in 1 BOTTLE (82725-3002-3) 30 tablet2025-09-01NoNoCurrent