Home NDC 51316-764 Cetirizine
Product NDC 51316-764
11-digit product format 513160764
Labeler code 51316
Product ID 51316-764_465428ca-3000-a730-e063-6394a90a1af4
Type HUMAN OTC DRUG
Nonproprietary name Cetiirizine
Dosage form TABLET
Route ORAL
Labeler CVS PHARMACY, INC
Application ANDA209274
Marketing category ANDA
Marketing start 2023-10-16
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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2017-12-22
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 2 · 43 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 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209274-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2017-12-22 f41ea6bd6efb…
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
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 51316-764-65 Cetirizine 365 in 1 BOTTLE TABLET 365 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-764 CETIRIZINE (CETIIRIZINE) TABLET [CVS PHARMACY, INC] 4 Current NDC, 1 package rows 20241120_fd8f495a-9940-363b-e053-6294a90a1097.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 3 · 56 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Allergy Relief CETIRIZINE HYDROCHLORIDE LIDL US LLC e5fd935d-5b60-7270-e053-2995a90a7141 2026-09-09 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE LIDL US LLC bcbbcb24-2a58-917a-e053-2a95a90af9a9 2026-08-07 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine hydrochloride - HIVES CETIRIZINE HYDROCHLORIDE Granules Pharmaceuticals Inc. 562b5e6c-6103-df3d-e063-6394a90a897d 2026-07-14 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE Granules India Ltd 6efd5a60-e281-43f9-a52c-a95f46fbcbfc 2026-07-14 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Medline CETIRIZINE HCL Medline Industries, LP a75cd557-e19b-fdd4-e053-2a95a90a8097 2026-06-04 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Allergy Relief CETIRIZINE HYDROCHLORIDE AAA PHARMACEUTICAL, INC. ac22558b-5c82-4ab9-95b8-53eedea46282 2026-05-28 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Allergy Relief CETIRIZINE HYDROCHLORIDE Grocery Outlet, Inc 441d049c-8844-955e-e063-6294a90a666d 2026-05-21 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TWIN MED, LLC 14317ee7-1061-4c2b-9427-3433e27f13f5 2026-04-01 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Allergy Relief CETIRIZINE HCL Bryant Ranch Prepack 7e4a2d02-c2b3-4a1f-8373-a0b0dec5ddea 2026-03-10 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 All Day Allergy Relief CETIRIZINE HCL P & L Development, LLC c5dab2f3-8f95-4b85-995b-23b21c762ae8 2026-02-23 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 All Day Allergy Relief CETIRIZINE HCL Strategic Sourcing Services LLC 2965303e-bedc-41fb-af97-827c30575091 2026-01-05 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE Granules USA, Inc. c8d711cd-7214-c7d5-e053-2995a90a6b67 2025-12-22 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE RETAIL BUSINESS SERVICES,LLC. 9f04520e-161d-3f7b-e053-2a95a90a678d 2025-12-19 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine HCL CETIRIZINE HCL Meijer 181c63dd-6ab8-909a-e063-6394a90af141 2025-12-19 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine CETIIRIZINE CVS PHARMACY, INC fd8f495a-9940-363b-e053-6294a90a1097 2025-12-19 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 ndc (product): 51316-764 Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE SAFEWAY ed0eecfb-85bf-63bf-e053-2995a90a0e03 2025-12-18 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Allergy Relief CETIRIZINE HYDROCHLORIDE VALU MERCHANDISERS COMPANY dc66bf53-820f-40a3-b5ef-c653dd375544 2025-12-11 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE Granules Pharmaceuticals Inc. d55dfce1-acef-3342-e053-2a95a90a4b83 2025-12-04 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 CAREALL Allergy Relief CETIRIZINE HCL New World Imports d3411eec-05b1-49b3-86e8-bc47ac0ef6b7 2025-12-01 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274 Allergy Relief CETIRIZINE HCL Family Dollar (FAMILY WELLNESS) b90b5ef2-5aa2-45ca-94b9-c9d9e5877e23 2025-09-25 Warnings Exact identifier application applno (ANDA): 209274 application number: ANDA209274
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51316-764-65 51316076465 365 TABLET in 1 BOTTLE (51316-764-65) 365 tablet 2023-10-16 No No Current