Childrens Allegra Hives

Product NDC
41167-4227
11-digit product format
411674227
Labeler code
41167
Product ID
41167-4227_37df2ad5-479f-4534-b550-e42479a3b2db
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine HCl
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chattem, Inc.
Application
NDA201373
Marketing category
NDA
Marketing start
2026-05-01
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
30 mg/5mL
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N201373-001CHILDREN'S ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORALRLD, RS2011-01-24
N201373-002CHILDREN'S ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-24

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N201373-00189330972030-08-02Drug product2015-02-19
N201373-00289330972030-08-02Drug product2015-02-19

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N201373-002CHILDREN'S ALLEGRA HIVES30MG/5MLSUSPENSION / ORALRLD2011-01-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N201373-002CHILDREN'S ALLEGRA HIVES30MG/5MLSUSPENSION / ORALRLD2011-01-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N201373-002CHILDREN'S ALLEGRA HIVES30MG/5MLSUSPENSION / ORALRLD2011-01-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2011-01-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N201373-001CHILDREN'S ALLEGRA ALLERGY30MG/5MLSUSPENSION / ORALRLD, RS2011-01-24782e0a99824c…
2021-12-28 21:50 UTC2021-12N201373-002CHILDREN'S ALLEGRA HIVES30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SUSPENSION / ORALRLD2011-01-24782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N201373-00189330972030-08-02Drug product2015-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201373-00289330972030-08-02Drug product2015-02-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201373-00189330972030-08-02Drug product2015-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201373-00289330972030-08-02Drug product2015-02-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N201373-00189330972030-08-02Drug product2015-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201373-00289330972030-08-02Drug product2015-02-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201373-00189330972030-08-02Drug product2015-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201373-00289330972030-08-02Drug product2015-02-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201373-00189330972030-08-02Drug product2015-02-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201373-00289330972030-08-02Drug product2015-02-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201373-00189330972030-08-02Drug product2015-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201373-00289330972030-08-02Drug product2015-02-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201373-00189330972030-08-02Drug product2015-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201373-00289330972030-08-02Drug product2015-02-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201373-00189330972030-08-02Drug product2015-02-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201373-00289330972030-08-02Drug product2015-02-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201373-00189330972030-08-02Drug product2015-02-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201373-00289330972030-08-02Drug product2015-02-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N201373-00189330972030-08-02Drug product2015-02-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N201373-00289330972030-08-02Drug product2015-02-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201373-00189330972030-08-02Drug product2015-02-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201373-00289330972030-08-02Drug product2015-02-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201373-00189330972030-08-02Drug product2015-02-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201373-00289330972030-08-02Drug product2015-02-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201373-00189330972030-08-02Drug product2015-02-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201373-00289330972030-08-02Drug product2015-02-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N201373-00189330972030-08-02Drug product2015-02-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05N201373-00289330972030-08-02Drug product2015-02-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201373-00189330972030-08-02Drug product2015-02-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201373-00289330972030-08-02Drug product2015-02-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N201373-00189330972030-08-02Drug product2015-02-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N201373-00289330972030-08-02Drug product2015-02-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N201373-00189330972030-08-02Drug product2015-02-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N201373-00289330972030-08-02Drug product2015-02-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N201373-00189330972030-08-02Drug product2015-02-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N201373-00289330972032-08-16Drug product2015-02-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N201373-00189330972030-08-02Drug product2015-02-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N201373-00289330972030-08-02Drug product2015-02-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N201373-00189330972030-08-02Drug product2015-02-19782e0a99824c…
2021-12-28 21:50 UTC2021-12N201373-00289330972030-08-02Drug product2015-02-19782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Allegra Hives
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE30 mg/5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
997491Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff50d9cd-d849-43e8-b32a-4dcde798d3ebAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-4227-1Childrens Allegra Hives1 in 1 CARTONSUSPENSION11
41167-4227-1Childrens Allegra Hives240 mL in 1 BOTTLE, PLASTICSUSPENSION2401

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Allegra HivesFEXOFENADINE HCLChattem, Inc.ff50d9cd-d849-43e8-b32a-4dcde798d3eb2026-05-01WarningsExact identifier
application applno (NDA): 201373
application number: NDA201373
ndc (product): 41167-4227
Childrens Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.e2bd23c7-dfba-463a-adbe-2183970da7402026-01-13WarningsExact identifier
application applno (NDA): 201373
application number: NDA201373

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997491fexofenadine HCl 30 MG in 5 mL Oral SuspensionPSNff50d9cd-d849-43e8-b32a-4dcde798d3eb1
997491fexofenadine hydrochloride 6 MG/ML Oral SuspensionSCDff50d9cd-d849-43e8-b32a-4dcde798d3eb1
997491fexofenadine HCl 30 MG per 5 ML Oral SuspensionSYff50d9cd-d849-43e8-b32a-4dcde798d3eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
41167-4227-1411674227011 BOTTLE, PLASTIC in 1 CARTON (41167-4227-1) / 240 mL in 1 BOTTLE, PLASTIC2026-05-01NoNoCurrent