Home NDC 72476-192 ALLERGY RELIEF
Product NDC 72476-192
11-digit product format 724760192
Labeler code 72476
Product ID 72476-192_cf22d677-c125-1721-e053-2a95a90a1c3e
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler RETAIL BUSINESS SERVICES , LLC.
Application ANDA211075
Marketing category ANDA
Marketing start 2021-07-14
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 Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2019-10-18 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2019-10-18
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ALLERGY RELIEF FEXOFENADINE HYDROCHLORIDE RETAIL BUSINESS SERVICES , LLC. c1be67ea-9973-49e2-e053-2995a90a423c 2021-10-24 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Additional Listing Data#
Finished product Yes
Brand name base ALLERGY RELIEF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FEXOFENADINE HYDROCHLORIDE 180 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 2S068B75ZU Rxcui 997420
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72476-192-04 ALLERGY RELIEF 1 in 1 CARTON TABLET 1 2 72476-192-04 ALLERGY RELIEF 30 in 1 BOTTLE, PLASTIC TABLET 30 2 72476-192-06 ALLERGY RELIEF 1 in 1 CARTON TABLET 1 2 72476-192-06 ALLERGY RELIEF 45 in 1 BOTTLE, PLASTIC TABLET 45 2 72476-192-09 ALLERGY RELIEF 90 in 1 BOTTLE, PLASTIC TABLET 90 2 72476-192-09 ALLERGY RELIEF 1 in 1 CARTON TABLET 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72476-192 ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [RETAIL BUSINESS SERVICES , LLC.] 2 Current NDC, Legacy NDC, 6 package rows 20211026_c1be67ea-9973-49e2-e053-2995a90a423c.zip
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 72476-192-04 72476019204 1 BOTTLE, PLASTIC in 1 CARTON (72476-192-04) / 30 TABLET in 1 BOTTLE, PLASTIC 2021-10-04 0000-00-00 No No Current 72476-192-06 72476019206 1 BOTTLE, PLASTIC in 1 CARTON (72476-192-06) / 45 TABLET in 1 BOTTLE, PLASTIC 2021-10-04 0000-00-00 No No Current 72476-192-09 72476019209 1 BOTTLE, PLASTIC in 1 CARTON (72476-192-09) / 90 TABLET in 1 BOTTLE, PLASTIC 2021-07-14 0000-00-00 No No Current