Signature Care Childrens Allergy Relief

Product NDC: 21130-475
11-digit product format: 211300475
Labeler code: 21130
Product ID: 21130-475_c39fc394-87f4-4226-bf04-b6dfd2631b72
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: Safeway
Application: ANDA204226
Marketing category: ANDA
Marketing start: 2015-09-28
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

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
21130-475-26	Signature Care Childrens Allergy Relief	1 in 1 CARTON	SOLUTION	1		2
21130-475-26	Signature Care Childrens Allergy Relief	120 mL in 1 BOTTLE	SOLUTION	120		2

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	SIGNATURE CARE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [SAFEWAY]	1
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	SIGNATURE CARE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [SAFEWAY]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	SIGNATURE CARE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [SAFEWAY]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SIGNATURE CARE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [SAFEWAY]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SIGNATURE CARE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [SAFEWAY]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	SIGNATURE CARE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [SAFEWAY]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	SIGNATURE CARE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [SAFEWAY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SIGNATURE CARE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [SAFEWAY]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-475	SIGNATURE CARE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [SAFEWAY]	2	Current NDC, Legacy NDC, 2 package rows	20181222_b7e7d503-94dd-469a-925f-62ebc16066f7.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
1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN	b7e7d503-94dd-469a-925f-62ebc16066f7	2
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	b7e7d503-94dd-469a-925f-62ebc16066f7	2
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	b7e7d503-94dd-469a-925f-62ebc16066f7	2
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	b7e7d503-94dd-469a-925f-62ebc16066f7	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-475-26	21130047526	1 BOTTLE in 1 CARTON (21130-475-26) / 120 mL in 1 BOTTLE	1 bottle	2015-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Better Living Brands LLC Children’s Allergy Relief Drug Facts	Safeway	2018-12-18	HUMAN OTC DRUG LABEL	2