Cetirizine Hydrochloride (Allergy)

Product NDC: 30142-169
Requested package NDC: 30142-169-12
11-digit product format: 301420169
Labeler code: 30142
Product ID: 30142-169_185308e9-76a6-4245-bdab-06b22a79a400
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: KROGER COMPANY
Application: ANDA209107
Marketing category: ANDA
Marketing start: 2021-03-24
Marketing end: 0000-00-00
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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	30142-169	30142-169-12	D	Discontinued by firm		2026-08-10

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 · 12 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2018-07-20
A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2018-07-20

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`782e0a99824c…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	ffbca2a4-8df0-4c85-adf9-9414cd706fb2	2026-02-26	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	WALGREEN CO.	3d2eac7f-db44-4771-8c7e-a38e68a7f24b	2025-04-05	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Better Living Brands, LLC	f7deb8ca-4a26-aece-e053-6294a90aa685	2023-11-22	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	1bbefda2-d3c5-4d31-b3ec-7da077e41157	2022-08-16	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	RITE AID CORPORATION	de169567-5cde-5c4a-e053-2a95a90a1215	2022-07-21	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	0b6e8c63-a76c-4184-a9cc-9691378c3ee5	2021-03-11	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107
Cetirizine Hydrochloride (Hives Relief)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	f0f486e1-2eeb-4eaa-b557-908bcbf973a8	2020-09-14	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
30142-169-12	30142016912	1 BOTTLE in 1 CARTON (30142-169-12) > 40 CAPSULE in 1 BOTTLE	1 bottle	2021-03-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride (Allergy) - KROGER COMPANY \| Aurohealth LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	KROGER COMPANY \| Aurohealth LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2021-03-29	Human OTC Drug Label	2