Home NDC 36800-691-13 topcare allergy relief
Product NDC 36800-691
Requested package NDC 36800-691-13
11-digit product format 368000691
Labeler code 36800
Product ID 36800-691_9cb64047-5e7e-4fbc-913a-e3831cf557f4
Type HUMAN OTC DRUG
Nonproprietary name fexofenadine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Topco Associates LLC
Application ANDA212971
Marketing category ANDA
Marketing start 2021-08-23
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 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 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 · 74 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 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…2021-12-28 21:50 UTC 2021-12 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212971-001 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2020-02-24 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212971-002 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2020-02-24 87673890dc5c…
Additional Listing Data#
Finished product Yes
Brand name base topcare allergy relief
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 36800-691-13 topcare allergy relief 5 in 1 CARTON TABLET, FILM COATED 5 3 36800-691-13 topcare allergy relief 1 in 1 BLISTER PACK TABLET, FILM COATED 1 3 36800-691-22 topcare allergy relief 1 in 1 BLISTER PACK TABLET, FILM COATED 1 3 36800-691-22 topcare allergy relief 15 in 1 CARTON TABLET, FILM COATED 15 3 36800-691-39 topcare allergy relief 1 in 1 CARTON TABLET, FILM COATED 1 3 36800-691-39 topcare allergy relief 30 in 1 BOTTLE TABLET, FILM COATED 30 3 36800-691-49 topcare allergy relief 40 in 1 BOTTLE TABLET, FILM COATED 40 3 36800-691-49 topcare allergy relief 1 in 1 CARTON TABLET, FILM COATED 1 3 36800-691-75 topcare allergy relief 1 in 1 CARTON TABLET, FILM COATED 1 3 36800-691-75 topcare allergy relief 90 in 1 BOTTLE TABLET, FILM COATED 90 3 36800-691-95 topcare allergy relief 45 in 1 BOTTLE TABLET, FILM COATED 45 3 36800-691-95 topcare allergy relief 1 in 1 CARTON TABLET, FILM COATED 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-691 TOPCARE ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 Current NDC, Legacy NDC, 12 package rows 20210925_e7658b5f-2d78-4f25-b1a3-e49198ca8f32.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 · 22 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-691-13 36800069113 5 BLISTER PACK in 1 CARTON (36800-691-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK 5 blister pack 2021-08-27 0000-00-00 No No Current