Home NDC 53943-130 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 TE codes RLD / RS Approval date A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2009-02-19 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2009-02-19 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2009-02-19 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2009-02-19
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 · 172 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078862-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-02-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078862-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-02-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078862-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-02-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078862-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2009-02-19 5bbf6a4d5a75…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Allergy Relief
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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
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 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# 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 Current 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 Current