Home NDC 59726-564 Allergy Relief
Product NDC 59726-564
11-digit product format 597260564
Labeler code 59726
Product ID 59726-564_0e656d13-42ab-456f-830c-08f5373bdade
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine HCL
Dosage form TABLET, COATED
Route ORAL
Labeler P & L Development, LLC
Application ANDA204097
Marketing category ANDA
Marketing start 2019-10-01
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59726-564-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59726-564-15 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59726-564-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59726-564-15 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59726-564-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59726-564-15 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59726-564-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59726-564-15 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59726-564-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59726-564-15 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59726-564-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59726-564-15 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59726-564-30 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59726-564-15 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59726-564-30 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59726-564-15 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59726-564-30 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59726-564-15 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2016-08-19 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2016-08-19 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2016-08-19
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 4 · 129 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 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 301d65b070ca…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59726-564-15 Allergy Relief 150 in 1 BOTTLE, PLASTIC TABLET, COATED 150 4 59726-564-15 Allergy Relief 1 in 1 BOX TABLET, COATED 1 4 59726-564-30 Allergy Relief 30 in 1 BOTTLE, PLASTIC TABLET, COATED 30 4 59726-564-30 Allergy Relief 1 in 1 BOX TABLET, COATED 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59726-564 ALLERGY RELIEF (FEXOFENADINE HCL) TABLET, COATED [P & L DEVELOPMENT, LLC] 4 Legacy NDC, 4 package rows 20221214_04abc65c-6967-47df-84b1-4f28fbaa3a68.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 · 21 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59726-564-15 59726056415 1 BOTTLE, PLASTIC in 1 BOX (59726-564-15) > 150 TABLET, COATED in 1 BOTTLE, PLASTIC 2019-10-01 0000-00-00 No No Current 59726-564-30 59726056430 1 BOTTLE, PLASTIC in 1 BOX (59726-564-30) > 30 TABLET, COATED in 1 BOTTLE, PLASTIC 2019-10-01 0000-00-00 No No Current