Allergy Relief

Product NDC
41250-741
Requested package NDC
41250-741-25
11-digit product format
412500741
Labeler code
41250
Product ID
41250-741_e3fbd066-0ca5-4677-9bc4-c2e9f16c7f62
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
MEIJER, INC.
Application
ANDA207235
Marketing category
ANDA
Marketing start
2018-03-31
Marketing end
2025-03-31
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
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41250-74141250-741-25DDiscontinued by firm2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41250-74141250-741-25DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41250-74141250-741-25DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207235-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2016-08-12

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-123f01610625f2…
2019-09-15 20:21 UTC2019-09A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12cb3db0bc1861…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
All Day Allergy ReliefCETIRIZINE HCLP & L Development, LLC0fb52421-a327-4747-880f-d2b7608ccd652025-11-17WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235
Allergy ReliefCETIRIZINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)d1703629-a641-403f-b547-032a75489d092025-07-01WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235
basic care all day allergyCETIRIZINE HYDROCHLORIDEAmazon.com Services LLCc3e987c5-7ca1-4514-aa0a-6668ff2937c52022-01-04WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235
CareOne Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerican Sales Company833e8904-d37d-4478-af7c-8287f2d079a72021-08-16WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235
dg health all day allergyCETIRIZINE HYDROCHLORIDEDolgencorp, LLCba7d3995-c992-457c-a628-f036d77cc6382021-06-01WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235
top care all day allergyCETIRIZINE HYDROCHLORIDETopco Associates LLC1a217b8a-621a-4b6d-a7ed-37b04f829d662020-06-08WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235
24 hour allergyCETIRIZINE HYDROCHLORIDEMeijer Distribution Ince64db82c-6632-421e-8212-e0879445c4d62020-06-04WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-741-25412500741251 BOTTLE in 1 BOX (41250-741-25) > 25 CAPSULE in 1 BOTTLE1 bottle2018-03-312025-03-31NoNoCurrent