berkley jensen allergy relief

Product NDC
68391-847
11-digit product format
683910847
Labeler code
68391
Product ID
68391-847_fa75f437-073a-439d-8282-d6a60fe2cbcf
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BJWC
Application
ANDA212971
Marketing category
ANDA
Marketing start
2022-02-27
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
berkley jensen allergy relief
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
2c6d9f8c-bc74-4e1a-bd51-50f84ab63a15Available 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
68391-847-47berkley jensen allergy relief1 in 1 CARTONTABLET, FILM COATED14
68391-847-47berkley jensen allergy relief150 in 1 BOTTLETABLET, FILM COATED1504
68391-847-48berkley jensen allergy relief180 in 1 BOTTLETABLET, FILM COATED1804
68391-847-48berkley jensen allergy relief2 in 1 PACKAGETABLET, FILM COATED24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-847BERKLEY JENSEN ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [BJWC]3Current NDC, Legacy NDC, 4 package rows20250521_2c6d9f8c-bc74-4e1a-bd51-50f84ab63a15.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEProficient Rx LP4a9b4b7f-0441-44d3-86c7-2542ef4b119a2022-12-01WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltde43b561e-d68a-47af-be93-d710f0f775052022-02-22WarningsExact identifier
application applno (ANDA): 212971
application number: ANDA212971
allergy reliefFEXOFENADINE HYDROCHLORIDEPublix Super Markets Inc76014f1e-fa48-4d64-9ce6-1eaebd0419fc2022-01-21WarningsExact 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 TabletPSN2c6d9f8c-bc74-4e1a-bd51-50f84ab63a154
997420fexofenadine hydrochloride 180 MG Oral TabletSCD2c6d9f8c-bc74-4e1a-bd51-50f84ab63a154
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY2c6d9f8c-bc74-4e1a-bd51-50f84ab63a154

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-847-47683910847471 BOTTLE in 1 CARTON (68391-847-47) / 150 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-270000-00-00NoNoCurrent
68391-847-48683910847482 BOTTLE in 1 PACKAGE (68391-847-48) / 180 TABLET, FILM COATED in 1 BOTTLE2 bottle2025-09-04NoNoCurrent