kirkland signature aller tec

Product NDC: 63981-458
11-digit product format: 639810458
Labeler code: 63981
Product ID: 63981-458_11b36474-0f5b-4454-8e5e-023c36ddad54
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Costco Wholesale Company
Application: ANDA078336
Marketing category: ANDA
Marketing start: 2008-03-25
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	63981-458	63981-458-00	D	Discontinued by firm		2026-07-31

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	Approval date
A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27
A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dg health all day allergy	CETIRIZINE HYDROCHLORIDE	Dolgencorp Inc	b9ac489a-80ed-4077-b68e-d03df1b892a6	2026-07-28	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
allergy relief	CETIRIZINE HYDROCHLORIDE	H E B	8649fc1e-ad56-4660-bbbb-8f1ed795697b	2026-07-20	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Major Pharmaceuticals	71db132d-dca4-47ef-8560-c68ad2258933	2026-05-04	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
All Day Allergy	CETIRIZINE HYDROCHLORIDE	HyVee Inc	8889af37-8345-4358-994d-7d8b847f4874	2026-04-22	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Cardinal Health 107, LLC	37c6d1e4-dd88-42a2-a828-539b68aa5dad	2026-04-16	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Allergy Relief Indoor and Outdoor Allergies	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy	98f3f2c6-da18-4055-81f1-962261360f9b	2026-03-31	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	7e158fd6-268d-4ffc-a410-d054090d54c5	2026-03-19	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
BERKLEY AND JENSEN ALL DAY ALLERGY	CETIRIZINE HYDROCHLORIDE	BJWC	b38c0068-5b06-4976-b68d-617bcc14f051	2026-02-11	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Major Pharmaceuticals	a5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a3	2026-01-29	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a462f9c0-45ef-49b1-b0d8-a02a75a4b731	2026-01-27	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Exchange select all day allergy	CETIRIZINE HYDROCHLORIDE	Army & Air Force Exchange Service	e7220494-3640-4b33-b577-ed3ca7c483e8	2026-01-15	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Good Sense all day allergy	CETIRIZINE HYDROCHLORIDE	L. Perrigo Company	2a7a27ab-1b4c-40d1-98bf-e4297aa25682	2026-01-08	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Northwind Health Company, LLC	f2b4d221-30ae-5a43-e053-2995a90a238a	2026-01-01	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
TopCare All Day Allergy	CETIRIZINE HYDROCHLORIDE	Topco Associates LLC	f2919aad-9ed4-40b8-b233-4aec06df33ea	2025-12-23	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Up and Up Allergy Relief	CETIRIZINE HYDROCHLORIDE	Target Corporation	ce93ca5b-2a65-4873-9686-926c44076c6c	2025-12-19	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	ff782956-03b7-4ae6-b78f-fb7fe78b262d	2025-12-05	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4a45672b-67d3-4739-86ec-0a6696dd83d4	2025-12-04	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
signature care allergy relief	CETIRIZINE HYDROCHLORIDE	Safeway	24099cbf-61ee-4ec8-a4ec-95a66ceaa0c0	2025-12-04	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
GOODNOW ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Gobrands, Inc	86ade508-8841-47d8-addb-418ecd6dc8de	2025-11-07	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	VERITYRX, LLC	43f40b92-f0e0-8808-e063-6394a90a656b	2025-10-30	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336

Additional Listing Data#

Finished product: Yes
Brand name base: kirkland signature aller tec
Brand name suffix: allergy
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1014678	Internal RxNorm lookup
1991946	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
d4a688aa-02d4-4af6-9a91-ed31679cfaf8	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
63981-458-00	kirkland signature aller tecallergy	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	9
63981-458-00	kirkland signature aller tecallergy	5 in 1 CARTON	TABLET, FILM COATED	5	9
63981-458-88	kirkland signature aller tecallergy	1 in 1 PACKAGE	TABLET, FILM COATED	1	9
63981-458-88	kirkland signature aller tecallergy	365 in 1 BOTTLE	TABLET, FILM COATED	365	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63981-458-88	EA - Each	63981-458	9143d56c-2045-40a6-a9f8-048aba1576d9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]	4
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]	4
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [COSTCO WHOLESALE COMPANY]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63981-458	KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	8	Current NDC, Legacy NDC, 4 package rows	20230531_d4a688aa-02d4-4af6-9a91-ed31679cfaf8.zip

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
1991946	Aller-Tec 10 MG Oral Tablet	PSN	d4a688aa-02d4-4af6-9a91-ed31679cfaf8	9
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	d4a688aa-02d4-4af6-9a91-ed31679cfaf8	9
1991946	cetirizine hydrochloride 10 MG Oral Tablet [Aller-Tec]	SBD	d4a688aa-02d4-4af6-9a91-ed31679cfaf8	9
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	d4a688aa-02d4-4af6-9a91-ed31679cfaf8	9
1991946	Aller-Tec 10 MG Oral Tablet	SY	d4a688aa-02d4-4af6-9a91-ed31679cfaf8	9
1014678	cetirizine HCl 10 MG Oral Tablet	SY	d4a688aa-02d4-4af6-9a91-ed31679cfaf8	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63981-458-00	63981045800	5 BLISTER PACK in 1 CARTON (63981-458-00) > 1 TABLET, FILM COATED in 1 BLISTER PACK	5 blister pack	2019-03-01	0000-00-00	No	No	Current
63981-458-88	63981045888	1 BOTTLE in 1 PACKAGE (63981-458-88) / 365 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2008-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Costco Wholesale Corp. Aller-Tec ® Drug Facts	Costco Wholesale Company	2025-06-10	HUMAN OTC DRUG LABEL	9