CHILDRENS ALLERGY RELIEF

Product NDC: 69230-316
Requested package NDC: 69230-316-11
11-digit product format: 692300316
Labeler code: 69230
Product ID: 69230-316_14a303ce-ffb0-acd3-e063-6294a90a9327
Type: HUMAN OTC DRUG
Nonproprietary name: cetirizine hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Camber Consumer Care Inc
Application: ANDA210622
Marketing category: ANDA
Marketing start: 2019-03-13
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

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
A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2019-03-13

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2019-03-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210622-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2019-03-13	`f41ea6bd6efb…`

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: CHILDRENS ALLERGY RELIEF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
64O047KTOA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1014673	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
941e4aa9-6388-424c-87ad-3ea2ec5aafea	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69230-316-11	CHILDRENS ALLERGY RELIEF	1 in 1 CARTON	SOLUTION	1		2
69230-316-11	CHILDRENS ALLERGY RELIEF	118 mL in 1 BOTTLE	SOLUTION	118		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69230-316-11	ML - Milliliter	69230-316	df4f780c-3b4f-4d07-a2b4-828a2bff508d	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69230-316	CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CAMBER CONSUMER CARE INC]	2	Current NDC, Legacy NDC, 2 package rows	20240328_941e4aa9-6388-424c-87ad-3ea2ec5aafea.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Camber Consumer Care Inc	941e4aa9-6388-424c-87ad-3ea2ec5aafea	2024-03-27	Warnings	Exact identifier application applno (ANDA): 210622 application number: ANDA210622 ndc (package): 69230-316-11 ndc (product): 69230-316 ndc11 (package): 69230031611
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	a6492645-8438-4e82-aa31-7e5b4bccb220	2023-12-15	Warnings	Exact identifier application applno (ANDA): 210622 application number: ANDA210622
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Strategic Sourcing Services	1dd63ede-37ca-4b5a-bfed-1aca5dd15424	2022-07-27	Warnings	Exact identifier application applno (ANDA): 210622 application number: ANDA210622

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
64O047KTOA	CETIRIZINE HYDROCHLORIDE	83881-52-1	CETIRIZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN	a6492645-8438-4e82-aa31-7e5b4bccb220	8
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	a6492645-8438-4e82-aa31-7e5b4bccb220	8
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	a6492645-8438-4e82-aa31-7e5b4bccb220	8
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	a6492645-8438-4e82-aa31-7e5b4bccb220	8
1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN	941e4aa9-6388-424c-87ad-3ea2ec5aafea	2
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	941e4aa9-6388-424c-87ad-3ea2ec5aafea	2
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	941e4aa9-6388-424c-87ad-3ea2ec5aafea	2
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	941e4aa9-6388-424c-87ad-3ea2ec5aafea	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69230-316-11	69230031611	1 BOTTLE in 1 CARTON (69230-316-11) / 118 mL in 1 BOTTLE	1 bottle	2019-03-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CHILDRENS ALLERGY RELIEF	Camber Consumer Care Inc \| Hetero Labs Limited Unit III \| Annora Pharma Private Limited	2024-03-27	HUMAN OTC DRUG LABEL	2
CHILDRENS ALLERGY RELIEF - A-S Medication Solutions	A-S Medication Solutions	2023-12-15	Human OTC Drug Label	8