Home NDC 51655-842 Cetirizine Hydrochloride Tablets,10 mg
Product NDC 51655-842
11-digit product format 516550842
Labeler code 51655
Product ID 51655-842_4bbb94e5-ada2-ab07-e063-6394a90a1b01
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Northwind Health Company, LLC
Application ANDA078933
Marketing category ANDA
Marketing start 2023-02-07
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 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 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2010-06-15 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-06-15 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2010-06-15 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-06-15
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 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078933-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2010-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078933-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2010-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078933-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2010-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078933-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2010-06-15 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 Tablets,10 mg
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51655-842-26 Cetirizine Hydrochloride Tablets,10 mg 90 in 1 BOTTLE, PLASTIC TABLET 90 4 51655-842-52 Cetirizine Hydrochloride Tablets,10 mg 30 in 1 BOTTLE, PLASTIC TABLET 30 4 51655-842-60 Cetirizine Hydrochloride Tablets,10 mg 100 in 1 BOTTLE, PLASTIC TABLET 100 4 51655-842-84 Cetirizine Hydrochloride Tablets,10 mg 14 in 1 BOTTLE, PLASTIC TABLET 14 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51655-842 CETIRIZINE HYDROCHLORIDE TABLETS,10 MG (CETIRIZINE HYDROCHLORIDE) TABLET [NORTHWIND PHARMACEUTICALS, LLC] 3 Current NDC, 4 package rows 20230420_f756d3b1-d2e4-3705-e053-6294a90aa380.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 · 8 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape) CETIRIZINE HYDROCHLORIDE MARKSANS PHARMA LIMITED 652b0c65-a3f2-4454-9cf2-51a3389282cc 2026-07-10 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 Cetirizine Hydrochloride Tablets,10 mg CETIRIZINE HYDROCHLORIDE Northwind Health Company, LLC f756d3b1-d2e4-3705-e053-6294a90aa380 2026-01-01 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 ndc (product): 51655-842 ALLERGY CETIRIZINE HYDROCHLORIDE Kroger Company bc020340-ef39-e49a-e053-2a95a90af810 2025-09-11 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 Allergy Relief CETIRIZINE HYDROCHLORIDE BETTER LIVING BRANDS, LLC eb60ae7d-87db-7413-e053-2a95a90afd76 2025-06-28 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 Cetirizine Hydrochloride Tablets,10 mg CETIRIZINE HYDROCHLORIDE TIME CAP LABORATORIES, INC. d78223ba-80d5-47f8-e053-2a95a90aebdb 2024-03-06 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 All Day Allergy Relief CETIRIZINE HYDROCHLORIDE DOLGENCORP, INC. 0643ea78-9709-8526-e063-6394a90a227b 2023-12-15 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 Allergy Relief CETIRIZINE HYDROCHLORIDE WALGREENS f3c66f47-016a-799a-e053-2995a90ad424 2023-10-21 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE TIME CAP LABORATORIES, INC. dfbddafb-9455-5805-e053-2a95a90ad0d9 2022-05-24 Warnings Exact identifier application applno (ANDA): 078933 application number: ANDA078933
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51655-842-26 51655084226 90 TABLET in 1 BOTTLE, PLASTIC (51655-842-26) 90 tablet 2023-02-07 No No Current 51655-842-52 51655084252 30 TABLET in 1 BOTTLE, PLASTIC (51655-842-52) 30 tablet 2023-04-07 No No Current 51655-842-60 51655084260 100 TABLET in 1 BOTTLE, PLASTIC (51655-842-60) 100 tablet 2023-03-30 No No Current 51655-842-84 51655084284 14 TABLET in 1 BOTTLE, PLASTIC (51655-842-84) 14 tablet 2023-03-10 No No Current