Home NDC 37808-391-02 Allergy Relief
Product NDC 37808-391
Requested package NDC 37808-391-02
11-digit product format 378080391
Labeler code 37808
Product ID 37808-391_e051ce8b-3163-69b9-e053-2a95a90ab739
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler HEB
Application ANDA211075
Marketing category ANDA
Marketing start 2022-05-31
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 60 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 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
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.
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 2026-08-01 22:54:32 2026-06 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 a50c72e98297…
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. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 3 · 57 matching rows.
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 60 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 997501 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 37808-391-02 Allergy Relief 1 in 1 CARTON TABLET 1 3 37808-391-02 Allergy Relief 12 in 1 BLISTER PACK TABLET 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-391 ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [HEB] 3 Current NDC, Legacy NDC, 2 package rows 20220601_7cb25829-3aee-4a82-869d-ab4259626584.zip
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 37808-391-02 37808039102 1 BLISTER PACK in 1 CARTON (37808-391-02) / 12 TABLET in 1 BLISTER PACK 1 blister pack 2022-05-31 0000-00-00 No No Current