Home NDC 72090-028-01 Allergy Relief
Product NDC 72090-028
Requested package NDC 72090-028-01
11-digit product format 720900028
Labeler code 72090
Product ID 72090-028_020923b5-3a55-4a8a-bd07-2c650368f8ec
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine HCl
Dosage form TABLET
Route ORAL
Labeler Pioneer Life Sciences, LLC
Application ANDA077829
Marketing category ANDA
Marketing start 2023-10-26
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2009-08-26 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL RS 2009-08-26 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2009-08-26 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2009-08-26
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 · 176 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 2026-10-15 13:18:30 2026-09 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077829-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2009-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077829-002 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL RS 2009-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077829-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2009-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077829-004 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2009-08-26 2680178bc6a6…
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 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 · 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 72090-028-20 Allergy Relief 200 in 1 BOTTLE TABLET 200 3 72090-028-01 Allergy Relief 300 in 1 BOTTLE TABLET 300 2 72090-028-03 ALLERGY RELIEF 10000 in 1 DRUM TABLET 10000 1 72090-028-04 Allergy Relief 500 in 1 BOTTLE TABLET 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72090-028 ALLERGY RELIEF (CETIRIZINE HCL) TABLET [PIONEER LIFE SCIENCES, LLC] 2 Current NDC, 1 package rows 20240522_205b42e0-9d02-4755-9ee6-5883147abeb3.zip 72090-028 ALLERGY RELIEF (CETIRIZINE HCL) TABLET [PIONEER LIFE SCIENCES, LLC] 1 Current NDC, 1 package rows 20241006_b275feae-56a1-4a60-a564-8d7b18c06aa2.zip
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 2 · 26 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72090-028-01 72090002801 300 TABLET in 1 BOTTLE (72090-028-01) 300 tablet 2024-10-03 No No Current