Home NDC 63941-923-04 Childrens Allergy
Product NDC 63941-923
Requested package NDC 63941-923-04
11-digit product format 639410923
Labeler code 63941
Product ID 63941-923_9b823fef-4aa0-413c-9306-aff6038788e9
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine HCL
Dosage form SUSPENSION
Route ORAL
Labeler Best Choice (Valu Merchandisers Company)
Application ANDA203330
Marketing category ANDA
Marketing start 2022-10-07
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 30 mg/5mL
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION / ORAL 2014-11-18 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG/5ML SUSPENSION / ORAL RS 2014-11-18
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203330-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG/5ML SUSPENSION / ORAL 2014-11-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203330-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG/5ML SUSPENSION / ORAL RS 2014-11-18 782e0a99824c…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63941-923 CHILDRENS ALLERGY (FEXOFENADINE HCL) SUSPENSION [BEST CHOICE (VALU MERCHANDISERS COMPANY)] 2 Legacy NDC 20241004_67c6b0d3-b168-46da-a2de-adfcc4804222.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 1 · 10 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63941-923-04 63941092304 1 BOTTLE, PLASTIC in 1 BOX (63941-923-04) > 118 mL in 1 BOTTLE, PLASTIC 2022-10-07 0000-00-00 No No Current