Home NDC 55154-5399 Cetirizine Hydrochloride
Product NDC 55154-5399
11-digit product format 551545399
Labeler code 55154
Product ID 55154-5399_4c6a67e4-53a4-417c-b960-e25464bc0954
Type HUMAN OTC DRUG
Nonproprietary name cetirizine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA076677
Marketing category ANDA
Marketing start 2012-03-30
Marketing end 2027-04-30
Substance CETIRIZINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
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 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2007-12-27 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2007-12-27 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2007-12-27 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG 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 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 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076677-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076677-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076677-003 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076677-004 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 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 Cetirizine Hydrochloride 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 55154-5399-0 Cetirizine Hydrochloride 1 in 1 BLISTER PACK TABLET, FILM COATED 1 14 55154-5399-0 Cetirizine Hydrochloride 10 in 1 BAG TABLET, FILM COATED 10 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CETIRIZINE HYDROCHLORIDE ACTIVE INGREDIENT 64O047KTOA CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 4 CETIRIZINE ACTIVE MOIETY YO7261ME24 CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 4 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 4 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-5399 CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] 12 Current NDC, Legacy NDC, 2 package rows 20240111_0b0190c7-acfd-4140-bcaf-9fe835ebaf49.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 · 3 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 55154-5399-0 55154539900 10 BLISTER PACK in 1 BAG (55154-5399-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2012-03-30 2027-04-30 No No Current