Home NDC 72288-537 Basic Care Allergy
Product NDC 72288-537
11-digit product format 722880537
Labeler code 72288
Product ID 72288-537_eee34268-6f37-4eac-ac56-eab0e631f15d
Type HUMAN OTC DRUG
Nonproprietary name fexofenadine hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Amazon.com Services LLC
Application ANDA212971
Marketing category ANDA
Marketing start 2024-04-18
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 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 Basic Care Allergy
Listing expiration 2026-12-31 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 72288-537-72 Basic Care Allergy 1 in 1 CARTON TABLET, COATED 1 2 72288-537-72 Basic Care Allergy 60 in 1 BOTTLE TABLET, COATED 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72288-537 BASIC CARE ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [AMAZON.COM SERVICES LLC] 2 Current NDC, 2 package rows 20240504_c29d281f-89dd-4c69-8572-6599400c660f.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72288-537-72 72288053772 1 BOTTLE in 1 CARTON (72288-537-72) / 60 TABLET, COATED in 1 BOTTLE 1 bottle 2024-04-18 No No Current