ALLERGY RELIEF

Product NDC: 72476-194
11-digit product format: 724760194
Labeler code: 72476
Product ID: 72476-194_c6f31728-fdb8-f78d-e053-2a95a90a253e
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: RETAIL BUSINESS SERVICES , LLC.
Application: ANDA209274
Marketing category: ANDA
Marketing start: 2020-07-01
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
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
A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL			2017-12-22

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	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`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: ALLERGY RELIEF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	10 mg/1

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
1014678	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
95bf367c-eea8-73f9-e053-2a95a90a3dea	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	SPL version
72476-194-01	ALLERGY RELIEF	1 in 1 CARTON	TABLET, COATED	1	3
72476-194-01	ALLERGY RELIEF	14 in 1 BOTTLE, PLASTIC	TABLET, COATED	14	3
72476-194-13	ALLERGY RELIEF	2 in 1 CARTON	TABLET, COATED	2	3
72476-194-13	ALLERGY RELIEF	90 in 1 BOTTLE, PLASTIC	TABLET, COATED	90	3
72476-194-14	ALLERGY RELIEF	1 in 1 PACKAGE	TABLET, COATED	1	3
72476-194-14	ALLERGY RELIEF	30 in 1 BOTTLE, PLASTIC	TABLET, COATED	30	3
72476-194-15	ALLERGY RELIEF	1 in 1 CARTON	TABLET, COATED	1	3
72476-194-15	ALLERGY RELIEF	70 in 1 BOTTLE, PLASTIC	TABLET, COATED	70	3
72476-194-16	ALLERGY RELIEF	90 in 1 BOTTLE, PLASTIC	TABLET, COATED	90	3
72476-194-16	ALLERGY RELIEF	1 in 1 CARTON	TABLET, COATED	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72476-194	ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [RETAIL BUSINESS SERVICES , LLC.]	3	Current NDC, Legacy NDC, 10 package rows	20210713_95bf367c-eea8-73f9-e053-2a95a90a3dea.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 3 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	f4da9adf-840d-4526-86a6-6666183fd107	2023-07-06	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	adcd0e8e-cca7-e1bb-e053-2995a90a83be	2023-05-17	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Crcle Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Innovus Pharmaceuticals, Inc.	640583b6-379d-4ad3-b00c-383377c54eed	2023-04-21	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	WINCO FOODS, LLC	f45f5920-d82f-6549-e053-2995a90ad58a	2023-04-11	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HCL	CVS PHARMACY, INC	34c9e7b3-ccba-4f22-a4d3-20724e7de486	2023-02-17	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	MARC GLASSMAN, INC.	951b6f19-15fe-45d7-e053-2995a90aa254	2022-10-06	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HCL	WinCo Foods, LLC	39a7d993-805d-4fe8-bc21-3b08e8f78b62	2022-05-11	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Magno-Humphries, Inc.	f0a3e654-5fec-4f98-84da-4c30500633b4	2021-10-28	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	95bf367c-eea8-73f9-e053-2a95a90a3dea	2021-07-12	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274 ndc (product): 72476-194
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Strive Pharmaceuticals Inc	a4ebeec7-0245-4f77-e053-2995a90a7e7f	2020-11-17	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	DISCOUNT DRUG MART	844e0e60-f293-4588-9f34-c866bdad6f53	2020-09-11	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HCL 10 MG	Allegiant Health	bef9e980-37b4-430d-8635-3354d578b3b8	2019-12-12	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274

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
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	95bf367c-eea8-73f9-e053-2a95a90a3dea	3
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	95bf367c-eea8-73f9-e053-2a95a90a3dea	3
1014678	cetirizine HCl 10 MG Oral Tablet	SY	95bf367c-eea8-73f9-e053-2a95a90a3dea	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72476-194-01	72476019401	1 BOTTLE, PLASTIC in 1 CARTON (72476-194-01) / 14 TABLET, COATED in 1 BOTTLE, PLASTIC	2020-07-01	0000-00-00	No	No	Current
72476-194-13	72476019413	2 BOTTLE, PLASTIC in 1 CARTON (72476-194-13) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC	2021-07-06	0000-00-00	No	No	Current
72476-194-14	72476019414	1 BOTTLE, PLASTIC in 1 PACKAGE (72476-194-14) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC	2020-07-01	0000-00-00	No	No	Current
72476-194-15	72476019415	1 BOTTLE, PLASTIC in 1 CARTON (72476-194-15) / 70 TABLET, COATED in 1 BOTTLE, PLASTIC	2020-07-01	0000-00-00	No	No	Current
72476-194-16	72476019416	1 BOTTLE, PLASTIC in 1 CARTON (72476-194-16) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC	2020-07-01	0000-00-00	No	No	Current