allergy and congestion relief d

Product NDC
11822-0147
11-digit product format
118220147
Labeler code
11822
Product ID
11822-0147_dfe68fc3-e564-49cf-a1e3-d94565488256
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride, Pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA210719
Marketing category
ANDA
Marketing start
2020-04-01
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct11822-0147DDiscontinued by firm2026-08-03
excluded packagepackage11822-014711822-0147-0DDiscontinued 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 productproduct11822-0147DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11822-014711822-0147-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16

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 UTC2026-02A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-163f01610625f2…
2019-09-15 20:21 UTC2019-09A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210719-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2018-11-16cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0147ALLERGY AND CONGESTION RELIEF D (CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [RITE AID CORPORATION]3Legacy NDC20230601_c6d5b88b-4b2e-49bb-bd00-77de29c17406.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 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
allergy relief-DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDERite Aid Corporationfdf98201-661c-4b1e-97f6-265807d90f762026-05-27WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
allergy relief D12CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Companyaa515879-9851-4915-bd41-51d81e585dd72026-02-28WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
ALLERGY RELIEF D12CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5b6cd5ba-bdca-434e-b024-0089aeeec6a12026-02-17WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
Allergy and Sinus ReliefCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEKroger Company28d3aee3-52fb-4e87-a6f2-4634f1770a702026-01-19WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
FOSTER AND THRIVE ALL DAY ALLERGY DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC796bea75-847a-40cd-892c-0905caae5c4e2025-12-10WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
All Day Allergy DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Companyb38cb1c8-3575-4283-8692-00cd4cd8d5cc2025-10-02WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
12 hour allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEMeijer Distribution Incb7019ea1-ca3d-4ddb-8cf4-e4ca7cb95e772025-06-19WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc821c3880-303d-470a-af6a-e13be7ab313f2025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
Cetirizine hydrochloride and Pseudoephedrine hydrochlorideCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd3260111b-35da-4f95-8081-51eae4b1ef452025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
topcare all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDETopco Associates LLC103df878-1455-414f-94cb-5b32a2d3e4b82025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
equate allergy relief d nasal decongestantCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEWALMART INC.7b7b8cce-ede6-47c6-91c8-88fd94cb292d2025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEKroger Company2f1df816-311b-444a-8040-21227016614b2025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacyfe26cba3-5b84-462c-ac2b-e9e09612ad1d2025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
Rugby Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDERugby Laboratories5c6ac9a2-4f0a-4297-9b83-988d54598f752025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
signature care allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDESafeway8f2bcfe7-aac3-4a57-8ebb-c6f8a5829c802025-02-12WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEH E Bb3ca8aae-04f2-4c00-9fb5-ce3ed7e6f1bb2025-02-11WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
kirkland signature aller tec dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECostco Wholesale Companya8e57b21-4622-4315-8e8e-437243be2fe12025-02-04WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
good sense all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Companyc7154370-5d91-4dc4-90ed-1d07d9bc59432025-02-04WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
good neighbor pharmacy all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEAmerisource Bergena7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b2025-01-03WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719
Leader Allergy Relief DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader3152060c-f613-49db-91d4-356d2070c4662023-06-15WarningsExact identifier
application applno (ANDA): 210719
application number: ANDA210719

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0147-01182201470024 BLISTER PACK in 1 CARTON (11822-0147-0) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK24 blister pack2020-04-010000-00-00NoNoCurrent