Cetirizine Hydrochloride

Product NDC: 16571-402
11-digit product format: 165710402
Labeler code: 16571
Product ID: 16571-402_538948d8-34aa-4460-8d66-ee8fcf4c60ab
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA077829
Marketing category: ANDA
Marketing start: 2009-10-01
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: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL		2009-08-26
A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RS	2009-08-26
A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL		2009-08-26
A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2009-08-26

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cetirizine Hydrochloride
Listing expiration: 2027-12-31

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
5481ccb3-b311-4b25-b923-4fe8522ea92b	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
16571-402-10	Cetirizine Hydrochloride	100 in 1 BOTTLE	TABLET	100	13
16571-402-30	Cetirizine Hydrochloride	300 in 1 BOTTLE	TABLET	300	13
16571-402-50	Cetirizine Hydrochloride	500 in 1 BOTTLE	TABLET	500	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-402-10	EA - Each	16571-402	2524d8a5-6929-4792-b28d-276f9c97b20e	1	2012-07-24
16571-402-50	EA - Each	16571-402	a6cd2ed0-855f-460d-a2cb-5f7054e8e849	1	2013-02-13
16571-402-90	EA - Each	16571-402	d8ef7ec6-0a15-4216-95b1-e5296fd2d242	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Cetirizine Hydrochloride	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]	7
Cetirizine	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]	7
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]	7
lactose	INACTIVE INGREDIENT	J2B2A4N98G	CETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]	7
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]	7
povidone	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]	7
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]	7
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE HYDROCHLORIDE TABLET [PACK PHARMACEUTICALS LLC]	7
Cetirizine Hydrochloride	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]	4
Cetirizine	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]	4
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]	4
lactose	INACTIVE INGREDIENT	J2B2A4N98G	CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]	4
lactose	INACTIVE INGREDIENT	J2B2A4N98G	CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]	4
povidone	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]	4
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]	4
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
Cetirizine Hydrochloride	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
Cetirizine Hydrochloride	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
Cetirizine	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
Cetirizine	ACTIVE MOIETY	YO7261ME24	CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CETIRIZINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	CETIRIZINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-402	CETIRIZINE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.]	12	Current NDC, Legacy NDC, 3 package rows	20240319_5481ccb3-b311-4b25-b923-4fe8522ea92b.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	f2f42f36-6b09-4140-e053-2a95a90af813	2026-06-29	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Goodmeds All Day Allergy Relief Cetirizine HCl	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	cd13a70e-b9e2-41be-97ea-f022442b6460	2026-04-08	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	Pioneer Life Sciences, LLC	5249b83c-30d4-4b5b-aeb1-f52418ba079f	2026-04-06	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Indoor and Outdoor Allergy Relief	CETIRIZINE HCL	Famora Inc.	2a94d25c-aacf-4f5c-b406-815f0e1d0611	2026-03-18	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sportpharm LLC	dd50d2e9-3de7-4c44-96ed-39ef04dae702	2026-02-06	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Strategic Sourcing Services LLC	54509525-ad99-4165-a571-47ece058e292	2026-01-29	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Prodose, Inc	e0e5f482-0282-410c-8c40-0a33ca4ea23a	2026-01-26	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	Pioneer Life Sciences, LLC	205b42e0-9d02-4755-9ee6-5883147abeb3	2025-12-23	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	Pioneer Life Sciences, LLC	b275feae-56a1-4a60-a564-8d7b18c06aa2	2025-12-23	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	NUVICARE LLC	c728edf3-e6b5-4860-b966-39cf3ee4ff77	2025-12-19	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
RIGHT REMEDIES ALL-DAY Allergy Relief	CETIRIZINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	8227edbe-88d5-4d79-9175-891dd9566357	2025-11-20	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	5481ccb3-b311-4b25-b923-4fe8522ea92b	2025-11-05	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829 ndc (product): 16571-402
ValuMeds All Day Allergy Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	3071238a-6b35-4da8-8305-eced56c513ce	2025-10-23	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
CVS Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy	3d711302-dc4e-0a69-e063-6394a90ade10	2025-09-18	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cabinet Allergy Relief Refill Cetirizine HCI	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	0eaf9d27-e221-4cdd-97bc-478c775e3d67	2025-07-03	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	NUVICARE LLC	09dfdce2-7184-4247-983c-a5667e4a9da1	2025-06-09	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
ALLERGY RELIEF	CETIRIZINE HCL	Pioneer Life Sciences, LLC	110adf3c-84ce-48a1-8a22-89ee3eec22d9	2025-06-01	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cabinet All Day Allergy Relief	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	889316bc-5f98-426a-9750-2fdb0c427408	2025-04-07	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Umasuto, LLC	9af4ab23-d6d3-43f9-a026-76fd9771963f	2025-03-06	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	4b192084-dfdc-47bc-a968-6f49e137b248	2024-07-25	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829

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	5481ccb3-b311-4b25-b923-4fe8522ea92b	13
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	5481ccb3-b311-4b25-b923-4fe8522ea92b	13
1014678	cetirizine HCl 10 MG Oral Tablet	SY	5481ccb3-b311-4b25-b923-4fe8522ea92b	13
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	4b192084-dfdc-47bc-a968-6f49e137b248	9
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	4b192084-dfdc-47bc-a968-6f49e137b248	9
1014678	cetirizine HCl 10 MG Oral Tablet	SY	4b192084-dfdc-47bc-a968-6f49e137b248	9
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	b7a580d5-edfc-41b5-9713-ea18eeb9252e	8
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	b7a580d5-edfc-41b5-9713-ea18eeb9252e	8
1014678	cetirizine HCl 10 MG Oral Tablet	SY	b7a580d5-edfc-41b5-9713-ea18eeb9252e	8
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	4913192a-7364-3f19-e054-00144ff8d46c	5
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	4913192a-7364-3f19-e054-00144ff8d46c	5
1014678	cetirizine HCl 10 MG Oral Tablet	SY	4913192a-7364-3f19-e054-00144ff8d46c	5
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	3a58cd65-a4ab-4aa9-a6a0-0860019642ce	4
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	3a58cd65-a4ab-4aa9-a6a0-0860019642ce	4
1014678	cetirizine HCl 10 MG Oral Tablet	SY	3a58cd65-a4ab-4aa9-a6a0-0860019642ce	4
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	afd7b4c9-9ef0-52e8-e053-2a95a90a6b33	3
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	4445548f-d11c-3c1b-e054-00144ff8d46c	3
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	4445548f-d11c-3c1b-e054-00144ff8d46c	3
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	afd7b4c9-9ef0-52e8-e053-2a95a90a6b33	3
1014678	cetirizine HCl 10 MG Oral Tablet	SY	4445548f-d11c-3c1b-e054-00144ff8d46c	3
1014678	cetirizine HCl 10 MG Oral Tablet	SY	afd7b4c9-9ef0-52e8-e053-2a95a90a6b33	3
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	0b116de8-55c5-44dc-b0b6-f5a919e39a65	2
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	f2f42f36-6b09-4140-e053-2a95a90af813	2
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	147e91e6-0840-05ee-e054-00144ff8d46c	2
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	147e91e6-0840-05ee-e054-00144ff8d46c	2
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	f2f42f36-6b09-4140-e053-2a95a90af813	2
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	0b116de8-55c5-44dc-b0b6-f5a919e39a65	2
1014678	cetirizine HCl 10 MG Oral Tablet	SY	147e91e6-0840-05ee-e054-00144ff8d46c	2
1014678	cetirizine HCl 10 MG Oral Tablet	SY	0b116de8-55c5-44dc-b0b6-f5a919e39a65	2
1014678	cetirizine HCl 10 MG Oral Tablet	SY	f2f42f36-6b09-4140-e053-2a95a90af813	2
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	3d3596d8-cebc-4bdf-be21-3f5a4e0446ad	1
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	dd50d2e9-3de7-4c44-96ed-39ef04dae702	1
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	df5f520a-9d1f-4b56-971c-cfb46416750f	1
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	3d3596d8-cebc-4bdf-be21-3f5a4e0446ad	1
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	dd50d2e9-3de7-4c44-96ed-39ef04dae702	1
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	df5f520a-9d1f-4b56-971c-cfb46416750f	1
1014678	cetirizine HCl 10 MG Oral Tablet	SY	3d3596d8-cebc-4bdf-be21-3f5a4e0446ad	1
1014678	cetirizine HCl 10 MG Oral Tablet	SY	dd50d2e9-3de7-4c44-96ed-39ef04dae702	1
1014678	cetirizine HCl 10 MG Oral Tablet	SY	df5f520a-9d1f-4b56-971c-cfb46416750f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-402-10	16571040210	100 TABLET in 1 BOTTLE (16571-402-10)	100 tablet	2009-10-01	0000-00-00	No	No	Current
16571-402-30	16571040230	300 TABLET in 1 BOTTLE (16571-402-30)	300 tablet	2026-05-10		No	No	Current
16571-402-50	16571040250	500 TABLET in 1 BOTTLE (16571-402-50)	500 tablet	2009-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy	St. Mary's Medical Park Pharmacy	2026-06-29	HUMAN OTC DRUG LABEL	4
Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy	Sportpharm LLC	2026-02-06	HUMAN OTC DRUG LABEL	1
Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy	Rising Pharma Holdings, Inc. \| Unique Pharmaceutical Laboratories	2025-11-05	Human OTC Drug Label	13
Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy	Preferred Pharmaceuticals, Inc.	2025-02-25	HUMAN OTC DRUG LABEL	14
Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy	Bryant Ranch Prepack	2024-07-25	HUMAN OTC DRUG LABEL	9
Cetirizine Hydrochloride Tablets, 10 mg, Allergy	NuCare Pharmaceuticals, Inc.	2024-07-15	HUMAN OTC DRUG LABEL	5
CETIRIZINE HYDROCHLORIDE	Direct_Rx	2023-10-09	HUMAN OTC DRUG LABEL	9
Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy	REMEDYREPACK INC.	2023-08-17	HUMAN OTC DRUG LABEL	18
CETIRIZINE HYDROCHLORIDE	DIRECT RX	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	3
Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-03	HUMAN OTC DRUG LABEL	3
Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy	Bryant Ranch Prepack	2022-05-02	HUMAN OTC DRUG LABEL	2
Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy	Bryant Ranch Prepack	2022-02-09	HUMAN OTC DRUG LABEL	2
Cetirizine 10 mg	RedPharm Drug \| EPM Packaging	2022-01-20	HUMAN OTC DRUG LABEL	3
Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy	RPK Pharmaceuticals, Inc.	2020-12-15	Human OTC Drug Label	3
Cetirizine Hydrochloride Tablets, 10 mg, Allergy	Lake Erie Medical DBA Quality Care Products LLC	2020-04-09	HUMAN OTC DRUG LABEL	5
Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy	A-S Medication Solutions	2020-01-18	Human OTC Drug Label	8
Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy	Proficient Rx LP	2019-10-01	HUMAN OTC DRUG LABEL	2
Cetirizine Hydrochloride	DIRECT RX	2015-11-09	HUMAN OTC DRUG LABEL	4
Cetirizine Hydrochloride Tablets, 10 mg, Allergy	Blenheim Pharmacal, Inc.	2015-04-24	HUMAN OTC DRUG LABEL	2
Cetirizine Hydrochloride Tablets, 10 mg, Allergy	Aidarex Pharmaceuticals LLC	2012-09-17	HUMAN OTC DRUG LABEL	1
Cetirizine HCL 10mg Tablet	Life Line Home Care Services, Inc.	2012-02-03	HUMAN OTC DRUG LABEL	1