Home NDC 68391-847-48 berkley jensen allergy relief
Product NDC 68391-847
Requested package NDC 68391-847-48
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212971-001 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 A212971-002 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 bb7c543d1eb4…
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 Ingredient Strength FEXOFENADINE HYDROCHLORIDE 180 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2S068B75ZU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997420 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68391-847-47 berkley jensen allergy relief 1 in 1 CARTON TABLET, FILM COATED 1 4 68391-847-47 berkley jensen allergy relief 150 in 1 BOTTLE TABLET, FILM COATED 150 4 68391-847-48 berkley jensen allergy relief 180 in 1 BOTTLE TABLET, FILM COATED 180 4 68391-847-48 berkley jensen allergy relief 2 in 1 PACKAGE TABLET, FILM COATED 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-847 BERKLEY JENSEN ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [BJWC] 3 Current NDC, Legacy NDC, 4 package rows 20250521_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 1 of 2 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68391-847-48 68391084748 2 BOTTLE in 1 PACKAGE (68391-847-48) / 180 TABLET, FILM COATED in 1 BOTTLE 2 bottle 2025-09-04 No No Current