signature care allergy relief

Product NDC
21130-090
Requested package NDC
21130-090-66
11-digit product format
211300090
Labeler code
21130
Product ID
21130-090_4a207903-34f2-4db3-a813-e02bd7f93053
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safeway
Application
ANDA078336
Marketing category
ANDA
Marketing start
2015-09-17
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

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 packagepackage21130-09021130-090-66DDiscontinued 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 · 1 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 packagepackage21130-09021130-090-66DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078336-001CETIRIZINE 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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
signature care 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
24099cbf-61ee-4ec8-a4ec-95a66ceaa0c0Available 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
21130-090-39signature care allergy relief30 in 1 BOTTLETABLET, FILM COATED309
21130-090-39signature care allergy relief1 in 1 CARTONTABLET, FILM COATED19
21130-090-48signature care allergy relief2 in 1 CARTONTABLET, FILM COATED29
21130-090-66signature care allergy relief14 in 1 CARTONTABLET, FILM COATED149
21130-090-66signature care allergy relief1 in 1 BLISTER PACKTABLET, FILM COATED19
21130-090-72signature care allergy relief1 in 1 CARTONTABLET, FILM COATED19
21130-090-72signature care allergy relief60 in 1 BOTTLETABLET, FILM COATED609
21130-090-75signature care allergy relief90 in 1 BOTTLETABLET, FILM COATED909
21130-090-76signature care allergy relief120 in 1 BOTTLETABLET, FILM COATED1209
21130-090-76signature care allergy relief1 in 1 CARTONTABLET, FILM COATED19
21130-090-95signature care allergy relief1 in 1 CARTONTABLET, FILM COATED19
21130-090-95signature care allergy relief45 in 1 BOTTLETABLET, FILM COATED459

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-090SIGNATURE CARE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [SAFEWAY]8Current NDC, Legacy NDC, 12 package rows20210225_24099cbf-61ee-4ec8-a4ec-95a66ceaa0c0.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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate allergy reliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb33eb97f-5ac3-4eb7-b23a-cf550ce462872026-08-05WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
dg health all day allergyCETIRIZINE HYDROCHLORIDEDolgencorp Incb9ac489a-80ed-4077-b68e-d03df1b892a62026-07-28WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
allergy reliefCETIRIZINE HYDROCHLORIDEH E B8649fc1e-ad56-4660-bbbb-8f1ed795697b2026-07-20WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEMajor Pharmaceuticals71db132d-dca4-47ef-8560-c68ad22589332026-05-04WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
All Day AllergyCETIRIZINE HYDROCHLORIDEHyVee Inc8889af37-8345-4358-994d-7d8b847f48742026-04-22WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDECardinal Health 107, LLC37c6d1e4-dd88-42a2-a828-539b68aa5dad2026-04-16WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Allergy Relief Indoor and Outdoor AllergiesCETIRIZINE HYDROCHLORIDECVS Pharmacy98f3f2c6-da18-4055-81f1-962261360f9b2026-03-31WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEBryant Ranch Prepack7e158fd6-268d-4ffc-a410-d054090d54c52026-03-19WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
BERKLEY AND JENSEN ALL DAY ALLERGYCETIRIZINE HYDROCHLORIDEBJWCb38c0068-5b06-4976-b68d-617bcc14f0512026-02-11WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEMajor Pharmaceuticalsa5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a32026-01-29WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a462f9c0-45ef-49b1-b0d8-a02a75a4b7312026-01-27WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Exchange select all day allergyCETIRIZINE HYDROCHLORIDEArmy & Air Force Exchange Servicee7220494-3640-4b33-b577-ed3ca7c483e82026-01-15WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEL. Perrigo Company2a7a27ab-1b4c-40d1-98bf-e4297aa256822026-01-08WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDENorthwind Health Company, LLCf2b4d221-30ae-5a43-e053-2995a90a238a2026-01-01WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
TopCare All Day AllergyCETIRIZINE HYDROCHLORIDETopco Associates LLCf2919aad-9ed4-40b8-b233-4aec06df33ea2025-12-23WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Up and Up Allergy ReliefCETIRIZINE HYDROCHLORIDETarget Corporationce93ca5b-2a65-4873-9686-926c44076c6c2025-12-19WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsff782956-03b7-4ae6-b78f-fb7fe78b262d2025-12-05WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4a45672b-67d3-4739-86ec-0a6696dd83d42025-12-04WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
signature care allergy reliefCETIRIZINE HYDROCHLORIDESafeway24099cbf-61ee-4ec8-a4ec-95a66ceaa0c02025-12-04WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (package): 21130-090-66
ndc (product): 21130-090
ndc11 (package): 21130009066
GOODNOW ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEGobrands, Inc86ade508-8841-47d8-addb-418ecd6dc8de2025-11-07WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN24099cbf-61ee-4ec8-a4ec-95a66ceaa0c09
1014678cetirizine hydrochloride 10 MG Oral TabletSCD24099cbf-61ee-4ec8-a4ec-95a66ceaa0c09
1014678cetirizine HCl 10 MG Oral TabletSY24099cbf-61ee-4ec8-a4ec-95a66ceaa0c09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-090-662113000906614 BLISTER PACK in 1 CARTON (21130-090-66) > 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2015-09-170000-00-00NoNoCurrent