Home NDC 72476-764 Cetirizine Hydrochloride
Product NDC 72476-764
11-digit product format 724760764
Labeler code 72476
Product ID 72476-764_46518a5f-819b-3a94-e063-6294a90a4533
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler RETAIL BUSINESS SERVICES,LLC.
Application ANDA209274
Marketing category ANDA
Marketing start 2020-04-21
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
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 Hydrochloride
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 72476-764-03 2023-03-02 24h Allergy Relief Cetirizine Hydrochloride Tablets, USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 72476-764-09 2023-03-02 24h Allergy Relief Cetirizine Hydrochloride Tablets, USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 72476-764-16 2023-03-02 24h Allergy Relief Cetirizine Hydrochloride Tablets, USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 72476-764-23 2023-03-02 24h Allergy Relief Cetirizine Hydrochloride Tablets, USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 72476-764-70 2023-03-02 24h Allergy Relief Cetirizine Hydrochloride Tablets, USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 72476-764-03 2023-01-30 24h Allergy Relief Cetirizine Hydrochloride Tablets, USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 72476-764-09 2023-01-30 24h Allergy Relief Cetirizine Hydrochloride Tablets, USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 72476-764-16 2023-01-30 24h Allergy Relief Cetirizine Hydrochloride Tablets, USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 72476-764-23 2023-01-30 24h Allergy Relief Cetirizine Hydrochloride Tablets, USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 72476-764-70 2023-01-30 24h Allergy Relief Cetirizine Hydrochloride Tablets, USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72476-764-03 Cetirizine Hydrochloride 30 in 1 BOTTLE TABLET 30 7 72476-764-09 Cetirizine Hydrochloride 90 in 1 BOTTLE TABLET 90 7 72476-764-16 Cetirizine Hydrochloride 14 in 1 BLISTER PACK TABLET 14 7 72476-764-23 Cetirizine Hydrochloride 120 in 1 BOTTLE TABLET 120 7 72476-764-70 Cetirizine Hydrochloride 70 in 1 BOTTLE TABLET 70 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72476-764 CETIRIZINE HYDROCHLORIDE TABLET [RETAIL BUSINESS SERVICES,LLC.] 6 Current NDC, Legacy NDC, 5 package rows 20241222_9f04520e-161d-3f7b-e053-2a95a90a678d.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 2 of 3 · 52 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 72476-764-03 72476076403 30 TABLET in 1 BOTTLE (72476-764-03) 30 tablet 2020-04-21 0000-00-00 No No Current 72476-764-09 72476076409 90 TABLET in 1 BOTTLE (72476-764-09) 90 tablet 2020-04-21 0000-00-00 No No Current 72476-764-16 72476076416 14 TABLET in 1 BLISTER PACK (72476-764-16) 14 tablet 2020-04-21 0000-00-00 No No Current 72476-764-23 72476076423 120 TABLET in 1 BOTTLE (72476-764-23) 120 tablet 2020-04-21 0000-00-00 No No Current 72476-764-70 72476076470 70 TABLET in 1 BOTTLE (72476-764-70) 70 tablet 2020-04-21 0000-00-00 No No Current