Cetirizine hydrochloride

Product NDC: 71309-005
Requested package NDC: 71309-005-03
11-digit product format: 713090005
Labeler code: 71309
Product ID: 71309-005_b0c6821d-4a7f-b6a7-e053-2995a90a7b9c
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Safrel Pharmaceuticals, LLC
Application: ANDA209274
Marketing category: ANDA
Marketing start: 2018-05-28
Marketing end: 0000-00-00
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71309-005	71309-005-03	I	Inactivated by FDA		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71309-005-03	2024-01-30	C162847	48780-1	1030e365-64c7-111a-e063-dadaa90a10e2	Cetrizine Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71309-005-03	Cetirizine hydrochloride	300 in 1 BOTTLE	TABLET, COATED	300		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71309-005	CETIRIZINE HYDROCHLORIDE TABLET, COATED [SAFREL PHARMACEUTICALS, LLC]	1	Legacy NDC, 1 package rows	20201004_b0c6821d-4a7e-b6a7-e053-2995a90a7b9c.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 2 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	CETIRIZINE HYDROCHLORIDE	FSA STORE INC.	ec6b4e86-ac27-e1f2-e053-2a95a90ab3e1	2025-03-07	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
ValuMeds 24-Hour Allergy Relief	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	fcb87d13-3385-4f4c-8d5e-6ba58e952e4e	2025-01-27	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
CABINET Allergy Relief	CETIRIZINE HYDROCHLORIDE	Spirit Pharmaceutical LLC	e49c3c91-aab8-478e-97fa-04ed06180021	2024-12-30	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Spirit Pharmaceutical LLC	507df969-804c-4e95-bb42-c1224fce2b28	2024-12-30	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Curist Allergy Relief	CETIRIZINE HYDROCHLORIDE	Little Pharma, Inc.	8c429732-5cf3-f41b-e053-2995a90a302a	2024-11-19	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Pentrexcilina Day time	CETIRIZINE HYDROCHLORIDE	OPMX LLC	26f56cb7-be58-a0c2-e063-6294a90a15fa	2024-11-15	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	4f2d0a71-fda5-435a-a220-3292cd74a42a	2024-10-11	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	6eb22b5a-ff30-44f8-aca2-3f73614515a8	2024-08-16	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	b53d5e8a-a30c-4025-aa72-d2776a112e3e	2024-06-24	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HCL	Strategic Sourcing Services LLC	9e996c4a-524e-4f93-8d46-ac289d8cdd67	2024-05-30	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HCL	Pioneer Life Sciences, LLC	b064f4ba-d5ff-c503-e053-2995a90ab1ec	2024-05-21	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	OPMX LLC	b452bca6-2c51-d0a1-e053-2995a90aff67	2024-05-17	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
CETIRIZINE HYDROCHLORIDE 10 MG	CETIRIZINE HYDROCHLORIDE	SDA Laboratories, Inc.	222a7e77-33a6-44ca-9ab1-0bc4fc431aa3	2024-01-11	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
CETIRIZINE HYDROCHLORIDE 10 MG	CETIRIZINE HYDROCHLORIDE	TWIN MED, LLC	d9437d88-da59-5567-e053-2995a90a362b	2024-01-03	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
CETIRIZINE HYDROCHLORIDE 10 MG	CETIRIZINE HYDROCHLORIDE	YYBA CORP	0502f197-21e1-44f2-b621-c8df1ccd956e	2024-01-03	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Spirit Pharmaceutical LLC	c9eb5102-5514-4e69-8169-be7341e9fb66	2023-12-06	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Amerifoods Trading Company	f6ce3cdf-2e6d-61e8-e053-6294a90af7d3	2023-11-02	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	HARRIS TEETER	b8f68d9d-2d3a-414a-e053-2a95a90a15ec	2023-10-30	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f7651ae0-b459-4540-a640-3c1e37190d18	2023-09-14	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	84f42ff2-1f51-4cbe-a2bb-dc024d2ff1a4	2023-09-14	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	b0c6821d-4a7e-b6a7-e053-2995a90a7b9c	1
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	b0c6821d-4a7e-b6a7-e053-2995a90a7b9c	1
1014678	cetirizine HCl 10 MG Oral Tablet	SY	b0c6821d-4a7e-b6a7-e053-2995a90a7b9c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71309-005-03	71309000503	300 TABLET, COATED in 1 BOTTLE (71309-005-03)	2018-05-28	0000-00-00	No	No	Current