Home NDC 63941-504 Allergy Relief
Product NDC 63941-504
11-digit product format 639410504
Labeler code 63941
Product ID 63941-504_d7cc376d-f8d3-427f-8737-12305c829d54
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine HCl
Dosage form TABLET
Route ORAL
Labeler Best Choice (Valu Merchandisers Company)
Application ANDA079112
Marketing category ANDA
Marketing start 2017-05-31
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63941-504-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63941-504-30 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2012-02-08 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2012-02-08 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2012-02-08 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2012-02-08 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2012-02-08 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2012-02-08
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 7 · 252 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 2026-08-18 06:07:40 2026-07 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 03ed91905a0d…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63941-504 ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [BEST CHOICE (VALU MERCHANDISERS COMPANY)] 4 Legacy NDC 20241004_1f935a97-5733-419d-af9e-f3a6f9661b91.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63941-504-30 63941050430 1 BOTTLE, PLASTIC in 1 BOX (63941-504-30) > 30 TABLET in 1 BOTTLE, PLASTIC 2017-05-31 0000-00-00 No No Current