Allergy Relief

Product NDC
50066-396
11-digit product format
500660396
Labeler code
50066
Product ID
50066-396_d5a01d33-2431-447c-83d2-081ee63663a1
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl 10 mg
Dosage form
TABLET
Route
ORAL
Labeler
Genomma Labs USA, Inc
Application
ANDA209274
Marketing category
ANDA
Marketing start
2017-12-22
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50066-396DDiscontinued by firm2026-10-12
excluded packagepackage50066-39650066-396-09DDiscontinued by firm2026-10-12
excluded packagepackage50066-39650066-396-30DDiscontinued by firm2026-10-12
excluded packagepackage50066-39650066-396-45DDiscontinued by firm2026-10-12
excluded packagepackage50066-39650066-396-82DDiscontinued by firm2026-10-12

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 · 51 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50066-396-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50066-396-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50066-396-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50066-396-82d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50066-396-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50066-396-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50066-396-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50066-396-82f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50066-396-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50066-396-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50066-396-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50066-396-822ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50066-396-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50066-396-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50066-396-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50066-396-82a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50066-396-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50066-396-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50066-396-09cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50066-396-82cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50066-396-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50066-396-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50066-396-09cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50066-396-82cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50066-396-45302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50066-396-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50066-396-09302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50066-396-82302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50066-396-45ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50066-396-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50066-396-09ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50066-396-82ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50066-396-450efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50066-396-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50066-396-090efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50066-396-820efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50066-396-45ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50066-396-09ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50066-396-45367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50066-396-09367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50066-396-45557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50066-396-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209274-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2017-12-22

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-2284e616aacf4f…
2026-08-18 06:07:402026-07A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefCETIRIZINE HYDROCHLORIDEFSA STORE INC.ec6b4e86-ac27-e1f2-e053-2a95a90ab3e12025-03-07WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
ValuMeds 24-Hour Allergy ReliefCETIRIZINE HYDROCHLORIDECabinet Health P.B.C.fcb87d13-3385-4f4c-8d5e-6ba58e952e4e2025-01-27WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
CABINET Allergy ReliefCETIRIZINE HYDROCHLORIDESpirit Pharmaceutical LLCe49c3c91-aab8-478e-97fa-04ed061800212024-12-30WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDESpirit Pharmaceutical LLC507df969-804c-4e95-bb42-c1224fce2b282024-12-30WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Curist Allergy ReliefCETIRIZINE HYDROCHLORIDELittle Pharma, Inc.8c429732-5cf3-f41b-e053-2995a90a302a2024-11-19WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Pentrexcilina Day timeCETIRIZINE HYDROCHLORIDEOPMX LLC26f56cb7-be58-a0c2-e063-6294a90a15fa2024-11-15WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.4f2d0a71-fda5-435a-a220-3292cd74a42a2024-10-11WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.6eb22b5a-ff30-44f8-aca2-3f73614515a82024-08-16WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsb53d5e8a-a30c-4025-aa72-d2776a112e3e2024-06-24WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HCLStrategic Sourcing Services LLC9e996c4a-524e-4f93-8d46-ac289d8cdd672024-05-30WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HCLPioneer Life Sciences, LLCb064f4ba-d5ff-c503-e053-2995a90ab1ec2024-05-21WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEOPMX LLCb452bca6-2c51-d0a1-e053-2995a90aff672024-05-17WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
CETIRIZINE HYDROCHLORIDE 10 MGCETIRIZINE HYDROCHLORIDESDA Laboratories, Inc.222a7e77-33a6-44ca-9ab1-0bc4fc431aa32024-01-11WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
CETIRIZINE HYDROCHLORIDE 10 MGCETIRIZINE HYDROCHLORIDETWIN MED, LLCd9437d88-da59-5567-e053-2995a90a362b2024-01-03WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
CETIRIZINE HYDROCHLORIDE 10 MGCETIRIZINE HYDROCHLORIDEYYBA CORP0502f197-21e1-44f2-b621-c8df1ccd956e2024-01-03WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDESpirit Pharmaceutical LLCc9eb5102-5514-4e69-8169-be7341e9fb662023-12-06WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerifoods Trading Companyf6ce3cdf-2e6d-61e8-e053-6294a90af7d32023-11-02WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEHARRIS TEETERb8f68d9d-2d3a-414a-e053-2a95a90a15ec2023-10-30WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f7651ae0-b459-4540-a640-3c1e37190d182023-09-14WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEA-S Medication Solutions84f42ff2-1f51-4cbe-a2bb-dc024d2ff1a42023-09-14WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50066-396-09500660396091 BLISTER PACK in 1 CARTON (50066-396-09) > 10 TABLET in 1 BLISTER PACK1 blister pack2019-09-200000-00-00NoNoCurrent
50066-396-305006603963030 TABLET in 1 BOTTLE (50066-396-30) 30 tablet2020-11-060000-00-00NoNoCurrent
50066-396-45500660396453 BLISTER PACK in 1 CARTON (50066-396-45) > 15 TABLET in 1 BLISTER PACK3 blister pack2019-09-200000-00-00NoNoCurrent
50066-396-825006603968290 TABLET in 1 BOTTLE (50066-396-82) 90 tablet2020-11-060000-00-00NoNoCurrent