Home NDC 69168-392 Allergy Relief
Product NDC 69168-392
11-digit product format 691680392
Labeler code 69168
Product ID 69168-392_9dbab14c-2a68-408a-961c-6325df359d73
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine HCl 10 mg
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Allegiant Health
Application ANDA078317
Marketing category ANDA
Marketing start 2014-12-16
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2007-12-27 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2007-12-27
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078317-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078317-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 782e0a99824c…
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 1014675 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 69168-392-25 Allergy Relief 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1 69168-392-25 Allergy Relief 25 in 1 BOTTLE CAPSULE, LIQUID FILLED 25 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-392 ALLERGY RELIEF (CETIRIZINE HCL 10 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH] 1 Current NDC, Legacy NDC, 2 package rows 20190101_96952314-fd4c-455f-b55e-645c19d6e366.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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69168-392-25 69168039225 1 BOTTLE in 1 CARTON (69168-392-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2014-12-16 0000-00-00 No No Current