Cetirizine

Product NDC
67046-680
11-digit product format
670460680
Labeler code
67046
Product ID
67046-680_6a707324-b32c-9741-e053-2a91aa0a2af2
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA078336
Marketing category
ANDA
Marketing start
2018-02-14
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67046-680IInactivated by FDA2026-10-05
excluded packagepackage67046-68067046-680-30IInactivated by FDA2026-10-05

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 · 36 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 packagepackage67046-680-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-680-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-680-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-680-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-680-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-680-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67046-680-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67046-680-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67046-680-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67046-680-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67046-680-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67046-680-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67046-680-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67046-680-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67046-680-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67046-680-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67046-680-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67046-680-30bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078336-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A078336-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27
A078336-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A078336-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-08-18 06:07:402026-07A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-275bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-680-30Cetirizine30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-680CETIRIZINE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20180422_6a707324-b32b-9741-e053-2a91aa0a2af2.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 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
signature care allergy reliefCETIRIZINE HYDROCHLORIDESafeway24099cbf-61ee-4ec8-a4ec-95a66ceaa0c02025-12-04WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
GOODNOW ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEGobrands, Inc86ade508-8841-47d8-addb-418ecd6dc8de2025-11-07WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEVERITYRX, LLC43f40b92-f0e0-8808-e063-6394a90a656b2025-10-30WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEA-S Medication Solutions88c3d23e-a0d8-4464-9414-666d74f11f662025-10-28WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
allergy reliefCETIRIZINE HYDROCHLORIDESafewayc5e74b2c-7871-4f28-a77d-0d674b9b8c5e2025-09-23WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Equaline all day allergyCETIRIZINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI491fae66-83b6-4beb-945b-39b9e4e021c52025-09-18WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc0827643a-29b8-487a-a158-28976d672d4d2025-09-12WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CareOne Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerican Sales Company533abfc1-226e-4a68-bfcc-ec046a4d57512025-08-25WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
welby allergy reliefCETIRIZINE HYDROCHLORIDEAldi Inccf6b3017-c8b6-4862-aa33-19ed02a43c282025-08-11WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
good neighbor pharmacy all day allergyCETIRIZINE HYDROCHLORIDEAmerisource Bergenc568e388-60ab-47be-b362-7832b83d06ad2025-07-21WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
leader all day allergyCETIRIZINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf2025-07-21WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
24 hour allergyCETIRIZINE HYDROCHLORIDEMeijer Distribution Inc2b03c026-3e8a-4283-981f-965bc084c03d2025-07-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
kirkland signature aller tec allergyCETIRIZINE HYDROCHLORIDECostco Wholesale Companyd4a688aa-02d4-4af6-9a91-ed31679cfaf82025-06-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepackae93976d-de9b-43a6-b299-ce1f1ae8d6f82025-05-21WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd91fe3ab8-c155-4482-9f06-f029d3563aad2025-03-06WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC25db4ca0-0c25-f3b6-e063-6394a90a88512024-11-01WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Members Mark Allergy ReliefCETIRIZINE HYDROCHLORIDESam's West Inc379756fd-f92d-4773-94fd-2682fcbdfba22024-05-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.af7513ae-5107-477c-a7da-0ded9d53a55c2024-03-27WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutions2f562a13-8909-4107-b135-10333707bab32024-01-24WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsc1a208c8-2554-4e8e-b506-aeb8e417d4442024-01-24WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN6a707324-b32b-9741-e053-2a91aa0a2af21
1014678cetirizine hydrochloride 10 MG Oral TabletSCD6a707324-b32b-9741-e053-2a91aa0a2af21
1014678cetirizine HCl 10 MG Oral TabletSY6a707324-b32b-9741-e053-2a91aa0a2af21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-680-306704606803030 TABLET in 1 BLISTER PACK (67046-680-30) 30 tablet2018-02-140000-00-00NoNoCurrent