Allergy Relief

Product NDC
33992-0811
Requested package NDC
33992-0811-2
11-digit product format
339920811
Labeler code
33992
Product ID
33992-0811_f97680f0-78b0-425e-8219-bbd70b79b596
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
Application
ANDA205291
Marketing category
ANDA
Marketing start
2018-09-30
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage33992-081133992-0811-2DDiscontinued by firm2026-08-17

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A205291-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2017-07-21

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-213f01610625f2…
2019-09-15 20:21 UTC2019-09A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21e64feba35796…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEStrides Pharma, Inc.29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba2026-08-24WarningsExact identifier
application applno (ANDA): 205291
application number: ANDA205291
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INCa57a0dbe-0926-4b25-a5d7-b8d499d671582026-05-11WarningsExact identifier
application applno (ANDA): 205291
application number: ANDA205291
Allergy ReliefCETIRIZINE HCLWALMART INC. (see also Equate)41bc1339-7137-4472-b47b-a7a36e24a9bb2025-04-29WarningsExact identifier
application applno (ANDA): 205291
application number: ANDA205291
All Day AllergyCETIRIZINE HCLCare One (American Sales Company)01d0729f-11ef-4ec5-8d8e-2863407c3f952025-04-07WarningsExact identifier
application applno (ANDA): 205291
application number: ANDA205291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33992-0811-2339920811021 BOTTLE, PLASTIC in 1 BOX (33992-0811-2) > 12 CAPSULE in 1 BOTTLE, PLASTIC2018-09-300000-00-00NoNoCurrent