FDA.reportPublic FDA data

GoodMeds Cetirizine 10mg

Product NDC
82725-4203
Requested package NDC
82725-4203-2
11-digit product format
827254203
Labeler code
82725
Product ID
82725-4203_5c26ccdc-b659-c821-e063-6294a90a3afb
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine 10mg
Dosage form
TABLET
Route
ORAL
Labeler
Cabinet Health P.B.C.
Application
ANDA209274
Marketing category
ANDA
Marketing start
2026-10-01
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 · 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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22c2088c7a36db…
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…

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
GoodMeds Cetirizine 10mg
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

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 startSampleExclude flagStatus
82725-4203-282725420302500 TABLET in 1 BOTTLE (82725-4203-2) 500 tablet2026-10-01NoNoCurrent