Childrens Allegra Allergy Oral Suspension

Manufacturer: Chattem, Inc.
Effective date: 2026-01-13
Label type: HUMAN OTC DRUG LABEL
Version: 27
Source: monthly-update
Hydrated at: 2026-06-03 17:51:47

Label at a glance#

ProductChildrens Allegra Allergy

Active ingredientFEXOFENADINE HYDROCHLORIDE

Label structure11 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, water eyes itching of the nose or throat

Dosage and administration

shake well before using use only with enclosed dosing cup adults and children 12 years of age and over take 10 mL every 12 hours; do not take more than 20 mL in 24 hours children 2 to under 12 years of age take 5 mL every 12 hours; do not take more than 10 mL in 24 hours children under 2 years of age ask a doctor adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor Note: mL = mi...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL)

Fexofenadine HCI 30 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, water eyes
itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before using
use only with enclosed dosing cup

adults and children 12 years of age and over	take 10 mL every 12 hours; do not take more than 20 mL in 24 hours
children 2 to under 12 years of age	take 5 mL every 12 hours; do not take more than 10 mL in 24 hours
children under 2 years of age	ask a doctor
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

Note: mL = milliliters

Other information

SPL UNCLASSIFIED SECTION

each 5 mL contains: each 5 mL contains: potassium 5 mg and sodium 19 mg
safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
store between 20° and 25°C (68° and 77°F)
color change from white to beige is expected over time. This does not impact product effectiveness and safety.

Inactive ingredients

INACTIVE INGREDIENT SECTION

edetate disodium, flavor, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucrose, titanium dioxide, xanthan gum, xylitol

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-800- 844 - 2798

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41167-4244-4
Children’s
Allegra®
ALLERGY
fexofenadine HCI
oral suspension
12 HR
30 mg/5 ml antihistamine

NDC 41167-4244-4 Children’s Allegra® ALLERGY fexofenadine HCI oral suspension 12 HR 30 mg/5 ml antihistamine

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41167-4246-4
Children’s
Allegra®
ALLERGY
fexofenadine HCI
oral suspension
12 HR
30 mg/5 ml antihistamine

NDC 41167-4246-4 Children’s Allegra® ALLERGY fexofenadine HCI oral suspension 12 HR 30 mg/5 ml antihistamine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
997493	Allegra 30 MG in 5 mL Oral Suspension	PSN	27
997491	fexofenadine HCl 30 MG in 5 mL Oral Suspension	PSN	27
997493	fexofenadine hydrochloride 6 MG/ML Oral Suspension [Allegra]	SBD	27
997491	fexofenadine hydrochloride 6 MG/ML Oral Suspension	SCD	27
997493	Allegra 30 MG per 5 ML Oral Suspension	SY	27
997493	Allegra 6 MG/ML Oral Suspension	SY	27
997491	fexofenadine HCl 30 MG per 5 ML Oral Suspension	SY	27

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FEXOFENADINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41167-4244-1	Childrens Allegra Allergy	1 in 1 CARTON	SUSPENSION	1	27
41167-4244-1	Childrens Allegra Allergy	240 mL in 1 BOTTLE	SUSPENSION	240	27
41167-4244-4	Childrens Allegra Allergy	1 in 1 CARTON	SUSPENSION	1	27
41167-4244-4	Childrens Allegra Allergy	120 mL in 1 BOTTLE	SUSPENSION	120	27
41167-4244-7	Childrens Allegra Allergy	120 mL in 1 BOTTLE	SUSPENSION	120	27
41167-4244-7	Childrens Allegra Allergy	3 in 1 CELLO PACK	SUSPENSION	3	27
41167-4246-2	Childrens Allegra Allergy	240 mL in 1 BOTTLE	SUSPENSION	240	27
41167-4246-2	Childrens Allegra Allergy	1 in 1 CARTON	SUSPENSION	1	27
41167-4246-4	Childrens Allegra Allergy	1 in 1 CARTON	SUSPENSION	1	27
41167-4246-4	Childrens Allegra Allergy	120 mL in 1 BOTTLE	SUSPENSION	120	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41167-4244-1	ML - Milliliter	41167-4244	e43b068e-ef19-4a13-bcc6-2205e632dbea	1	2015-02-02
41167-4244-4	ML - Milliliter	41167-4244	65c37209-de9e-4f43-83ce-0c202ddc7dd4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	12
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	12
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	12
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	12
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	12
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	12
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	12
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	INACTIVE INGREDIENT	70WT22SF4B	12
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	12
SUCROSE	INACTIVE INGREDIENT	C151H8M554	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	12
WATER	INACTIVE INGREDIENT	059QF0KO0R	12
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	12
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Childrens Allegra Allergy
Fexofenadine Hydrochloride
FEXOFENADINE
EDETATE DISODIUM
POLOXAMER 407
PROPYLENE GLYCOL
WATER
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SUCROSE
TITANIUM DIOXIDE
XANTHAN GUM
POTASSIUM SORBATE
XYLITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41167-4244	41167-4244-4, 41167-4244-1, 41167-4244-7
41167-4246	41167-4246-4, 41167-4246-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB
EDETATE DISODIUM	7FLD91C86K	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	70WT22SF4B	IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	IACT
SUCROSE	C151H8M554	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
XANTHAN GUM	TTV12P4NEE	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
XYLITOL	VCQ006KQ1E	IACT
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB
EDETATE DISODIUM	7FLD91C86K	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	70WT22SF4B	IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	IACT
SUCROSE	C151H8M554	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
XANTHAN GUM	TTV12P4NEE	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
XYLITOL	VCQ006KQ1E	IACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
26	2024-10-01	full-release	2026-06-01 00:24:06

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 77 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL	10 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	70WT22SF4B	SUSPENSION / ORAL	200 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL	64 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL	360 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL	27120 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL	27120 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL	64 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL	64 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION / ORAL	48209 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL	113 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL	1500 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL	1500 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	70WT22SF4B	SUSPENSION / ORAL	200 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL	113 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL	64 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / ORAL	104 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL	30 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL	10 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL	1500 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL	10 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL	1500 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / ORAL	104 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / ORAL	104 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL	30 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL	64 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	70WT22SF4B	SUSPENSION / ORAL	200 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL	1500 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL	360 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL	360 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL	30 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL	1500 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL	360 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION / ORAL	48209 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL	64 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL	113 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL	10 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL	10 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL	12 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	70WT22SF4B	SUSPENSION / ORAL	200 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	70WT22SF4B	SUSPENSION / ORAL	200 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL	12 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL	12 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL	113 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / ORAL	104 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / ORAL	104 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	70WT22SF4B	SUSPENSION / ORAL	200 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL	113 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL	113 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL	30 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL	360 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL	30 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL	10 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / ORAL	104 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL	27120 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / ORAL	10 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION / ORAL	48209 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL	12 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION / ORAL	48209 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION / ORAL	48209 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL	113 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N201373-001	CHILDREN'S ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG/5ML	SUSPENSION / ORAL		RLD, RS	2011-01-24
N201373-002	CHILDREN'S ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD	2011-01-24

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201373-001	8933097	2030-08-02		Drug product	2015-02-19
N201373-002	8933097	2030-08-02		Drug product	2015-02-19

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2011-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML	SUSPENSION / ORAL	RLD	2011-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML	SUSPENSION / ORAL	RLD	2011-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201373-001	CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	SUSPENSION / ORAL	RLD, RS	2011-01-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201373-002	CHILDREN'S ALLEGRA HIVES	30MG/5ML	SUSPENSION / ORAL	RLD	2011-01-24	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201373-002	8933097	2030-08-02	Drug product	2015-02-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201373-001	8933097	2030-08-02	Drug product	2015-02-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201373-002	8933097	2032-08-16	Drug product	2015-02-19	`74a2ff9319b5…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	e2bd23c7-dfba-463a-adbe-2183970da740	2026-01-13	Warnings	Exact identifier ndc (package): 41167-4244-1 ndc (package): 41167-4246-4 ndc (package): 41167-4244-7 ndc (package): 41167-4246-2 ndc (package): 41167-4244-4 ndc (product): 41167-4246 ndc (product): 41167-4244 ndc11 (package): 41167424404 ndc11 (package): 41167424602 ndc11 (package): 41167424604 ndc11 (package): 41167424407 ndc11 (package): 41167424401 spl id: 606e69ed-df38-4228-942d-a2625c26a803 spl set id: e2bd23c7-dfba-463a-adbe-2183970da740

Reported adverse events (FAERS/openFDA)#

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