Allergy Relief

Product NDC: 53943-130
11-digit product format: 539430130
Labeler code: 53943
Product ID: 53943-130_502476ab-e17d-bf5a-e063-6294a90a84fe
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Tablets
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DISCOUNT DRUG MART, INC
Application: ANDA078862
Marketing category: ANDA
Marketing start: 2026-05-20
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	10 mg/1

Field, Values table
Field	Values
Unii	64O047KTOA
Rxcui	1014678

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	SPL version
53943-130-13	Allergy Relief	1 in 1 CARTON	TABLET, FILM COATED	1	2
53943-130-13	Allergy Relief	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	2
53943-130-17	Allergy Relief	1 in 1 CARTON	TABLET, FILM COATED	1	2
53943-130-17	Allergy Relief	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	2

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
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	4b9576dc-d7f9-dc10-e063-6294a90a233e	2
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	4b9576dc-d7f9-dc10-e063-6294a90a233e	2
1014678	cetirizine HCl 10 MG Oral Tablet	SY	4b9576dc-d7f9-dc10-e063-6294a90a233e	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
53943-130-13	53943013013	1 BOTTLE, PLASTIC in 1 CARTON (53943-130-13) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2026-05-20	No	No	Historical
53943-130-17	53943013017	1 BOTTLE, PLASTIC in 1 CARTON (53943-130-17) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2026-05-20	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Tablets - DISCOUNT DRUG MART, INC \| Bionpharma Inc. \| OrBion Pharmaceuticals Private Limited	DISCOUNT DRUG MART, INC \| Bionpharma Inc. \| OrBion Pharmaceuticals Private Limited	2026-04-23	HUMAN OTC DRUG LABEL	2