CABINET Allergy Relief

Product NDC
68210-0119
11-digit product format
682100119
Labeler code
68210
Product ID
68210-0119_2a804c42-e22a-703e-e063-6394a90a3b1b
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Spirit Pharmaceutical LLC
Application
ANDA209274
Marketing category
ANDA
Marketing start
2019-10-25
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
2026-12-31
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
CABINET Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
64O047KTOAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014678Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e49c3c91-aab8-478e-97fa-04ed06180021Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-0119-0CABINET Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1008
68210-0119-1CABINET Allergy Relief300 in 1 BOTTLETABLET, FILM COATED3008
68210-0119-3CABINET Allergy Relief1 in 1 CARTONTABLET, FILM COATED18
68210-0119-3CABINET Allergy Relief30 in 1 BOTTLE, PLASTICTABLET, FILM COATED308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0119CABINET ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [SPIRIT PHARMACEUTICAL LLC]8Current NDC, Legacy NDC, 4 package rows20250101_e49c3c91-aab8-478e-97fa-04ed06180021.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 3 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsf4da9adf-840d-4526-86a6-6666183fd1072023-07-06WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIadcd0e8e-cca7-e1bb-e053-2995a90a83be2023-05-17WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Crcle Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEInnovus Pharmaceuticals, Inc.640583b6-379d-4ad3-b00c-383377c54eed2023-04-21WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEWINCO FOODS, LLCf45f5920-d82f-6549-e053-2995a90ad58a2023-04-11WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INC34c9e7b3-ccba-4f22-a4d3-20724e7de4862023-02-17WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEMARC GLASSMAN, INC.951b6f19-15fe-45d7-e053-2995a90aa2542022-10-06WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HCLWinCo Foods, LLC39a7d993-805d-4fe8-bc21-3b08e8f78b622022-05-11WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEMagno-Humphries, Inc.f0a3e654-5fec-4f98-84da-4c30500633b42021-10-28WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
ALLERGY RELIEFCETIRIZINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.95bf367c-eea8-73f9-e053-2a95a90a3dea2021-07-12WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEStrive Pharmaceuticals Inca4ebeec7-0245-4f77-e053-2995a90a7e7f2020-11-17WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEDISCOUNT DRUG MART844e0e60-f293-4588-9f34-c866bdad6f532020-09-11WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HCL 10 MGAllegiant Healthbef9e980-37b4-430d-8635-3354d578b3b82019-12-12WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNe49c3c91-aab8-478e-97fa-04ed061800218
1014678cetirizine hydrochloride 10 MG Oral TabletSCDe49c3c91-aab8-478e-97fa-04ed061800218
1014678cetirizine HCl 10 MG Oral TabletSYe49c3c91-aab8-478e-97fa-04ed061800218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-0119-068210011900100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68210-0119-0) 2019-10-250000-00-00NoNoCurrent
68210-0119-168210011901300 TABLET, FILM COATED in 1 BOTTLE (68210-0119-1) 2020-03-100000-00-00NoNoCurrent
68210-0119-3682100119031 BOTTLE, PLASTIC in 1 CARTON (68210-0119-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2020-03-100000-00-00NoNoCurrent