Home NDC 69168-450 Allergy Relief
Product NDC 69168-450
11-digit product format 691680450
Labeler code 69168
Product ID 69168-450_ad7557a2-3e0a-4069-b1a2-250e97ca189e
Type HUMAN OTC DRUG
Nonproprietary name Allergy Relief
Dosage form TABLET
Route ORAL
Labeler Allegiant Health
Application ANDA204097
Marketing category ANDA
Marketing start 2024-04-17
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 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2016-08-19 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2016-08-19 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2016-08-19
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.
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 if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.
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 69168-450-06 Allergy Relief 120 in 1 BOTTLE TABLET 120 4 69168-450-30 Allergy Relief 30 in 1 BOTTLE TABLET 30 4 69168-450-80 Allergy Relief 180 in 1 BOTTLE TABLET 180 4 69168-450-82 Allergy Relief 90 in 1 BOTTLE TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-450 ALLERGY RELIEF TABLET [ALLEGIANT HEALTH] 3 Current NDC, 4 package rows 20250515_89ece1b5-7604-4dce-a8a6-df5b948e3cff.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69168-450-06 69168045006 120 TABLET in 1 BOTTLE (69168-450-06) 120 tablet 2025-08-22 No No Current 69168-450-30 69168045030 30 TABLET in 1 BOTTLE (69168-450-30) 30 tablet 2025-08-22 No No Current 69168-450-80 69168045080 180 TABLET in 1 BOTTLE (69168-450-80) 180 tablet 2024-04-17 No No Current 69168-450-82 69168045082 90 TABLET in 1 BOTTLE (69168-450-82) 90 tablet 2024-04-17 No No Current