Home DailyMed dda452db-25a0-4409-96dd-a13ee73eba0b Fexofenadine HCl Tablets USP Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Physicians Total Care, Inc.
Effective date 2011-04-25
Label type HUMAN OTC DRUG LABEL
Version 1
Source full-release
Hydrated at 2026-05-31 22:29:30 Label at a glance# Product Fexofenadine hydrochloride
Active ingredient Fexofenadine Hydrochloride
Label structure 11 sections
Dosage and administration adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use Adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
Storage and handling store between 20° - 25°C (68° - 77°F) protect from excessive moisture
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 997420 fexofenadine HCl 180 MG 24 HR Oral Tablet PSN 1 997420 fexofenadine hydrochloride 180 MG Oral Tablet SCD 1 997420 fexofenadine HCl 180 MG 24 HR Oral Tablet SY 1
DailyMed Pharmacologic Classes# 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 54868-6289-0 Fexofenadine hydrochloride 30 in 1 BOTTLE TABLET 30 1 54868-6289-1 Fexofenadine hydrochloride 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54868-6289 FEXOFENADINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 2 package rows 20110913_dda452db-25a0-4409-96dd-a13ee73eba0b.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII SPL version Uploaded Fexofenadine Hydrochloride ACTIVE INGREDIENT 2S068B75ZU 1 FEXOFENADINE ACTIVE MOIETY E6582LOH6V 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA 1 FERRIC OXIDE BLACK INACTIVE INGREDIENT XM0M87F357 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 1 mannitol INACTIVE INGREDIENT 3OWL53L36A 1 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ 1 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP 1
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 13 matching rows.
Fexofenadine hydrochloride FEXOFENADINE SILICON DIOXIDE CROSCARMELLOSE SODIUM magnesium stearate mannitol POWDERED CELLULOSE FD&C RED NO. 40 HYPROMELLOSE 2910 (6 MPA.S) FERRIC OXIDE BLACK polyethylene glycol 400 TITANIUM DIOXIDE STARCH, CORN Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 12 matching rows.
Inactive ingredient matches# Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
Inactive ingredient links page 1 of 1 · 11 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 9 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076502-001 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2006-04-11 A076502-002 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2006-04-11 A076502-003 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2006-04-11 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-04-12 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-04-12 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-04-12 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-04-12 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2011-04-12 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2011-04-12
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 10 · 387 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 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2006-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2006-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2006-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-04-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2006-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2006-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2006-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2006-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2006-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2006-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2006-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2006-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2006-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2006-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2006-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2006-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
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 · 2 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.