FDA.reportPublic FDA data

Allegra Allergy 24 hour

Product NDC
85237-1920
11-digit product format
852371920
Labeler code
85237
Product ID
85237-1920_533b5815-fd4f-eff3-e063-6294a90ada9a
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Select Consumer Group
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-18
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Allegra Allergy 24 hour
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2S068B75ZUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
997420Internal RxNorm lookup
997422Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2de81a41-8488-7e39-e063-6294a90a394bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

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 68 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC1695e7ea-2f83-4d3a-980e-c91be6c1f2a52025-12-25WarningsExact identifier
application number: M012
GUAIFENESINGUAIFENESINPharbest Pharmaceuticals, Inc.0bf70fb4-d3c8-476d-b864-4eadc697a7d82025-12-24WarningsExact identifier
application number: M012
PHARBINEX-DMGUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MGPharbest Pharmaceuticals, Inc.8d71db43-da87-45ee-aa4a-7e870bc5016d2025-12-24WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLSafeway, Inc.764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be2025-12-23WarningsExact identifier
application number: M012
TussinGUAIFENESINDiscount Drug Mart14de3d6d-4eb0-42cf-8941-cb42b3dd5c712025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCc8dcba06-a461-4af5-a120-666a63f06ac42025-12-23WarningsExact identifier
application number: M012
SAFETUSSIN MAX STRENGTH MS Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES920bde5f-4079-45de-aa59-24b00e50cb562025-12-23WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd46996bbf-948c-0aba-e063-6394a90a09e32025-12-23WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.1d2e2a5a-099b-41b3-82bd-5bf704377f782025-12-23WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.5b493ed7-9044-4841-9935-236d0bdc71a92025-12-23WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.77a7ff9a-a414-4053-8d8d-369907d4380d2025-12-23WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.8f320235-f243-4211-b99c-18526e6865482025-12-23WarningsExact identifier
application number: M012
Circle K Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.b6a46498-d9a8-4da2-9283-57d135f305a52025-12-23WarningsExact identifier
application number: M012
Circle K Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.7c5faec2-28c6-4c15-a268-d8b578140b742025-12-23WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLWalmart67650b94-adbb-87fb-e053-2a91aa0a87e62025-12-23WarningsExact identifier
application number: M012
Equate Benz-Dex Cough and Throat LozengesBENZOCAINEWalmartc0a6cb7f-a247-e610-e053-2a95a90a41992025-12-23WarningsExact identifier
application number: M012
Equate Honey Lemon Cough DropsMENTHOLWalMart0028be18-5162-ff51-e063-6294a90ae5172025-12-23WarningsExact identifier
application number: M012
Equate SF Menthol Cough DropsMENTHOLWalMart003a229c-b014-e9f3-e063-6294a90aa5ed2025-12-23WarningsExact identifier
application number: M012
Equate Menthol Cough DropsMENTHOLWalmart124e6968-f59c-39d4-e063-6294a90a66d42025-12-23WarningsExact identifier
application number: M012
Equate Severe Menthol Throat DropMENTHOLWalmart125f3f5a-52aa-e398-e063-6394a90a00122025-12-23WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85237-1920-1852371920011 POUCH in 1 BLISTER PACK (85237-1920-1) / 1 TABLET, FILM COATED in 1 POUCH1 pouch2025-02-18NoNoCurrent