Childrens Xyzal Allergy

Product NDC: 41167-3535
11-digit product format: 411673535
Labeler code: 41167
Product ID: 41167-3535_bf07d0c3-0342-4fcc-82e4-954ee3076de0
Type: HUMAN OTC DRUG
Nonproprietary name: Levocetirizine dihydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Chattem, Inc.
Application: NDA209090
Marketing category: NDA
Marketing start: 2023-02-01
Substance: LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength: 2.5 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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 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…`
2022-10-28 04:53 UTC	2022-10	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209090-001	XYZAL ALLERGY 24HR	2.5MG/5ML	SOLUTION / ORAL	RLD, RS	2017-01-31	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209090-001	8633194	2027-10-16	Drug product	2017-02-28	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens Xyzal Allergy
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOCETIRIZINE DIHYDROCHLORIDE	2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOD6A38AGA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855168	Internal RxNorm lookup
855170	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a33f2704-d350-428b-b467-91f4775ce17f	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41167-3535-0	Childrens Xyzal Allergy	1 in 1 CARTON	SOLUTION	1	22
41167-3535-0	Childrens Xyzal Allergy	148 mL in 1 BOTTLE	SOLUTION	148	22
41167-3535-1	Childrens Xyzal Allergy	296 mL in 1 BOTTLE	SOLUTION	296	22
41167-3535-1	Childrens Xyzal Allergy	1 in 1 CARTON	SOLUTION	1	22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41167-3535	CHILDRENS XYZAL ALLERGY (LEVOCETIRIZINE DIHYDROCHLORIDE) SOLUTION [CHATTEM, INC.]	18	Current NDC, 4 package rows	20250228_a33f2704-d350-428b-b467-91f4775ce17f.zip

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 application applno (NDA): 209090 application number: NDA209090 ndc (product): 41167-3535

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOD6A38AGA	LEVOCETIRIZINE DIHYDROCHLORIDE	130018-87-0	LEVOCETIRIZINE DIHYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855168	levocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution	PSN	a33f2704-d350-428b-b467-91f4775ce17f	22
855170	XYZAL 2.5 MG in 5 mL 24HR Oral Solution	PSN	a33f2704-d350-428b-b467-91f4775ce17f	22
855170	levocetirizine dihydrochloride 0.5 MG/ML Oral Solution [Xyzal]	SBD	a33f2704-d350-428b-b467-91f4775ce17f	22
855168	levocetirizine dihydrochloride 0.5 MG/ML Oral Solution	SCD	a33f2704-d350-428b-b467-91f4775ce17f	22
855168	levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution	SY	a33f2704-d350-428b-b467-91f4775ce17f	22
855170	Xyzal 0.5 MG/ML Oral Solution	SY	a33f2704-d350-428b-b467-91f4775ce17f	22
855170	Xyzal 2.5 MG per 5 ML 24 HR Oral Solution	SY	a33f2704-d350-428b-b467-91f4775ce17f	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
41167-3535-0	41167353500	1 BOTTLE in 1 CARTON (41167-3535-0) / 148 mL in 1 BOTTLE	1 bottle	2023-02-01	No	No	Current
41167-3535-1	41167353501	1 BOTTLE in 1 CARTON (41167-3535-1) / 296 mL in 1 BOTTLE	1 bottle	2023-04-01	No	No	Current