Childrens Xyzal Allergy

Manufacturer: Chattem, Inc.
Effective date: 2026-02-05
Label type: HUMAN OTC DRUG LABEL
Version: 23
Source: daily-update
Hydrated at: 2026-06-11 05:10:26

Label at a glance#

ProductChildrens Xyzal Allergy

Active ingredientLEVOCETIRIZINE DIHYDROCHLORIDE

Label structure12 sections

Indications and uses

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

Dosage and administration

■ use only with enclosed dosing cup adults 65 years of age and older ■ ask a doctor adults and children 12-64 years of age ■ take 5 mL or 10 mL once daily in the evening depending upon severity of symptoms ■ do not take more than 10 mL in 24 hours children 6-11 years of age ■ take 5 mL once daily in the evening ■ do not take more than 5 mL in 24 hours children 2-5 years of age ■ take 2.5 mL once daily in the eveni...

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Children’s Xyzal^®Allergy 24HR

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Levocetirizine dihydrochloride 2.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

■ if you have kidney disease

■ if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ ever had trouble urinating or emptying your bladder

When using this product

OTC - WHEN USING SECTION

■ drowsiness may occur

■ avoid alcoholic drinks

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ be careful when driving a motor vehicle or operating machinery

■ in rare cases, you may experience itching after stopping levocetirizine. Consult your healthcare provider if this happens.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ you have trouble urinating or emptying your bladder

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

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

■ if breast-feeding: not recommended

■ if pregnant: 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

■ use only with enclosed dosing cup

adults 65 years of age and older	■ ask a doctor
adults and children 12-64 years of age	■ take 5 mL or 10 mL once daily in the evening depending upon severity of symptoms ■ do not take more than 10 mL in 24 hours
children 6-11 years of age	■ take 5 mL once daily in the evening ■ do not take more than 5 mL in 24 hours
children 2-5 years of age	■ take 2.5 mL once daily in the evening ■ do not take more than 2.5 mL in 24 hours
children under 2 years of age	■ do not use
consumers with kidney disease	■ do not use
Note: mL=milliliters

Other information

SPL UNCLASSIFIED SECTION

■ each 5 mL contains: sodium 3 mg

■ store between 20° and 25°C (68° and 77°F)

■ safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor, glacial acetic acid, glycerin, maltitol solution, methylparaben, propylparaben, purified water, saccharin sodium, sodium acetate trihydrate

Questions or comments?

OTC - QUESTIONS SECTION

call 1-8 66 - 844 - 2798

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children’s Xyzal
Allergy 24HR
Liquid
Grape Flavor

PRINCIPAL DISPLAY PANEL Children’s Xyzal Allergy 24HR Liquid Grape Flavor

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children’s Xyzal
Allergy 24HR
Liquid
Tutti Frutti Flavor

PRINCIPAL DISPLAY PANEL Children’s Xyzal Allergy 24HR Liquid Tutti Frutti Flavor

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children’s Xyzal
Allergy 24HR
Liquid
Bubble Gum Flavor

PRINCIPAL DISPLAY PANEL Children’s Xyzal Allergy 24HR Liquid Bubble Gum Flavor

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760	Product name	7	20190702
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41167-3530-1	ML - Milliliter	41167-3530	306687a6-6f5e-4c5f-9e28-73c28285c9c7	1	2017-04-05
41167-3533-1	ML - Milliliter	41167-3533	fd4586e3-f0d7-47f0-945d-e8d20b0609cc	1	2026-03-17

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Childrens Xyzal Allergy
Levocetirizine dihydrochloride
LEVOCETIRIZINE
ACETIC ACID
GLYCERIN
MALTITOL
METHYLPARABEN
PROPYLPARABEN
WATER
SACCHARIN SODIUM
SODIUM ACETATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41167-3535	41167-3535-0, 41167-3535-1
41167-3530	41167-3530-1
41167-3533	41167-3533-0, 41167-3533-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LEVOCETIRIZINE DIHYDROCHLORIDE	SOD6A38AGA	ACTIB
ACETIC ACID	Q40Q9N063P	IACT
GLYCERIN	PDC6A3C0OX	IACT
MALTITOL	D65DG142WK	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM ACETATE	4550K0SC9B	IACT
LEVOCETIRIZINE DIHYDROCHLORIDE	SOD6A38AGA	ACTIB
ACETIC ACID	Q40Q9N063P	IACT
GLYCERIN	PDC6A3C0OX	IACT
MALTITOL	D65DG142WK	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM ACETATE	4550K0SC9B	IACT
LEVOCETIRIZINE DIHYDROCHLORIDE	SOD6A38AGA	ACTIB
ACETIC ACID	Q40Q9N063P	IACT
GLYCERIN	PDC6A3C0OX	IACT
MALTITOL	D65DG142WK	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM ACETATE	4550K0SC9B	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
22	2026-01-21	full-release	2026-06-01 01:35:59

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 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209090-001	XYZAL ALLERGY 24HR	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL		RLD, RS	2017-01-31

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209090-001	8633194	2027-10-16		Drug product	2017-02-28

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`3a93d1ddd44b…`

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 Xyzal Allergy	LEVOCETIRIZINE DIHYDROCHLORIDE	Chattem, Inc.	a33f2704-d350-428b-b467-91f4775ce17f	2026-02-05	Warnings	Exact identifier ndc (package): 41167-3535-1 ndc (package): 41167-3533-0 ndc (package): 41167-3535-0 ndc (package): 41167-3533-1 ndc (package): 41167-3530-1 ndc (product): 41167-3535 ndc (product): 41167-3533 ndc (product): 41167-3530 ndc11 (package): 41167353301 ndc11 (package): 41167353500 ndc11 (package): 41167353501 ndc11 (package): 41167353300 ndc11 (package): 41167353001 spl id: 3ce97c09-ae27-48cf-9413-0c7190a1fb94 spl set id: a33f2704-d350-428b-b467-91f4775ce17f

Reported adverse events (FAERS/openFDA)#

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