FDA.reportPublic FDA data

Allergy Relief

Product NDC
36800-761
11-digit product format
368000761
Labeler code
36800
Product ID
36800-761_ee29473d-92cb-d23a-e053-2a95a90a1343
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
ANDA211075
Marketing category
ANDA
Marketing start
2021-09-30
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct36800-761DDiscontinued by firm2026-07-31
excluded packagepackage36800-76136800-761-02DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2019-10-18
A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2019-10-18

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefFEXOFENADINE HCLFamily Dollar (FAMILY WELLNESS)9d33bc80-696c-4f21-b38d-2cad0c1f09ad2026-07-09WarningsExact identifier
Allergy ReliefFEXOFENADINE HYDROCHLORIDECVS PHARMACYc77ee2bb-dc95-d8c9-e053-2995a90a96022026-07-08WarningsExact identifier
Allergy ReliefFEXOFENADINE HCLWALMART INC. (see also Equate)eb37cf76-49e2-4332-b449-1ce475556ef52026-07-08WarningsExact identifier
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEGranules India Ltd3151bc6d-b40b-4200-a5cf-e57b6791d92a2026-06-15WarningsExact identifier
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEGranules India Limitede0537b71-fdee-4122-9c09-868ce73520802026-06-15WarningsExact identifier
Allergy ReliefFEXOFENADINE HCLFSA Store Inc. (Caring Mills)d33f15db-0e5e-4515-b7a7-cb2760469ac12026-06-11WarningsExact identifier
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEYYBA Corp53e87aa4-9db3-9ded-e063-6294a90a319e2026-06-10WarningsExact identifier
Allergy ReliefFEXOFENADINE HYDROCHLORIDEGrocery Outlet, Inc.441ce66e-515a-d380-e063-6394a90aec7d2026-05-21WarningsExact identifier
Allergy ReliefFEXOFENADINE HYDROCHLORIDENUVICARE LLC895de6e9-c5b6-42fe-b450-f5d8331ce2e32026-05-21WarningsExact identifier
Fexofenadine HCl 180 mgFEXOFENADINE HCLFarmacias De Similares TX LLC49753406-729b-e48f-e063-6394a90a722a2026-04-08WarningsExact identifier
Allergy ReliefFEXOFENADINE HCLSafeway, Inc.a29e33ac-77f7-4e06-b6f1-82ecaa919cad2026-01-26WarningsExact identifier
Allergy ReliefFEXOFENADINE HYDROCHLORIDEHYVEE INC3e61ffb1-1c52-1ad5-e063-6294a90a6e3f2026-01-13WarningsExact identifier
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAMZ789 LLC1e46343f-d6b6-73ba-e063-6394a90acd942026-01-07WarningsExact identifier
Fexofenadine HCLFEXOFENADINE HCLSafeway, Incf32e9cb6-af93-e60a-e053-2995a90a42f52025-12-19WarningsExact identifier
Fexofenadine HCLFEXOFENADINE HCLMeijer, Inc.16de2c5d-b27b-9fb4-e063-6394a90a83902025-12-19WarningsExact identifier
Fexofenadine HCLFEXOFENADINE HCLMeijer181c7faf-b27d-0a2d-e063-6294a90ad1f42025-12-19WarningsExact identifier
Fexofenadine HCLFEXOFENADINE HCLTARGET CORPORATIONfdb8451b-fba3-c7ca-e053-6294a90a05d72025-12-19WarningsExact identifier
Fexofenadine HCLFEXOFENADINE HCLWalgreensfd775af1-782e-bb4f-e053-6294a90aaa5d2025-12-19WarningsExact identifier
Fexofenadine HCLFEXOFENADINE HCLCVS00ef8467-30a0-7579-e063-6294a90a75af2025-12-19WarningsExact identifier
Fexofenadine HCLFEXOFENADINE HCLCVS013ef192-5184-b720-e063-6394a90a98c42025-12-19WarningsExact 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 (1-800-222-1222) right away.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-761ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2Legacy NDC20221124_cb19fce3-1ee7-9f42-e053-2a95a90ac272.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-761-02368000761021 BLISTER PACK in 1 PACKAGE (36800-761-02) > 12 TABLET in 1 BLISTER PACK1 blister pack2021-09-300000-00-00NoNoCurrent