Kirkland Signature Childrens Aller Tec

Product NDC: 63981-475
11-digit product format: 639810475
Labeler code: 63981
Product ID: 63981-475_fcdbe753-6a33-4c46-acfe-3ead668364ec
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: Costco Wholesale Company
Application: ANDA204226
Marketing category: ANDA
Marketing start: 2016-07-08
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 5 mg/5mL
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	5 mg/5mL

Field, Values table
Field	Values
Unii	64O047KTOA
Rxcui	1014673, 1020017

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63981-475-34	Kirkland Signature Childrens Aller Tec	240 mL in 1 BOTTLE	SOLUTION	240		3
63981-475-43	Kirkland Signature Childrens Aller Tec	2 in 1 CARTON	SOLUTION	2		3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63981-475-43	ML - Milliliter	63981-475	c3ca982b-182f-43b3-94e0-21bf32a81545	1	2023-03-13

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63981-475	KIRKLAND SIGNATURE CHILDRENS ALLER TEC (CETIRIZINE HCL) SOLUTION [COSTCO WHOLESALE COMPANY]	3	Current NDC, Legacy NDC, 2 package rows	20230531_eb14a311-7918-4c4b-ae05-7606cfb8a4af.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1020017	Aller-Tec 5 MG in 5 mL Oral Solution	PSN	eb14a311-7918-4c4b-ae05-7606cfb8a4af	3
1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN	eb14a311-7918-4c4b-ae05-7606cfb8a4af	3
1020017	cetirizine hydrochloride 1 MG/ML Oral Solution [Aller-Tec]	SBD	eb14a311-7918-4c4b-ae05-7606cfb8a4af	3
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	eb14a311-7918-4c4b-ae05-7606cfb8a4af	3
1020017	Aller-Tec (cetirizine dihydrochloride 1 MG/ML) Oral Solution	SY	eb14a311-7918-4c4b-ae05-7606cfb8a4af	3
1020017	Aller-Tec 1 MG/ML Oral Solution	SY	eb14a311-7918-4c4b-ae05-7606cfb8a4af	3
1020017	Aller-Tec 5 MG per 5 ML Oral Solution	SY	eb14a311-7918-4c4b-ae05-7606cfb8a4af	3
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	eb14a311-7918-4c4b-ae05-7606cfb8a4af	3
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	eb14a311-7918-4c4b-ae05-7606cfb8a4af	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63981-475-34	63981047534	240 mL in 1 BOTTLE	240 ml					Historical
63981-475-43	63981047543	2 BOTTLE in 1 CARTON (63981-475-43) / 240 mL in 1 BOTTLE (63981-475-34)	2 bottle	2016-07-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Costco Wholesale Corp. Children’s Aller-Tec ® Drug Facts	Costco Wholesale Company	2023-05-04	HUMAN OTC DRUG LABEL	3