FDA.reportPublic FDA data

TopCare All Day Allergy

Product NDC
36800-458
Requested package NDC
36800-458-06
11-digit product format
368000458
Labeler code
36800
Product ID
36800-458_dc4e4803-536c-4a2b-9faa-e307a66eb91a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA078336
Marketing category
ANDA
Marketing start
2008-01-10
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 packagepackage36800-45836800-458-06DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078336-001CETIRIZINE 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…
2024-10-29 15:01 UTC2024-10A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
TopCare All Day Allergy
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
f2919aad-9ed4-40b8-b233-4aec06df33eaAvailable 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
36800-458-06TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-06TopCare All Day Allergy70 in 1 BOTTLETABLET, FILM COATED708
36800-458-13TopCare All Day Allergy5 in 1 CARTONTABLET, FILM COATED58
36800-458-13TopCare All Day Allergy1 in 1 BLISTER PACKTABLET, FILM COATED18
36800-458-39TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-39TopCare All Day Allergy30 in 1 BOTTLETABLET, FILM COATED308
36800-458-47TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-47TopCare All Day Allergy150 in 1 BOTTLETABLET, FILM COATED1508
36800-458-58TopCare All Day Allergy40 in 1 BOTTLETABLET, FILM COATED408
36800-458-58TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-66TopCare All Day Allergy14 in 1 CARTONTABLET, FILM COATED148
36800-458-66TopCare All Day Allergy1 in 1 BLISTER PACKTABLET, FILM COATED18
36800-458-72TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-72TopCare All Day Allergy60 in 1 BOTTLETABLET, FILM COATED608
36800-458-75TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-75TopCare All Day Allergy90 in 1 BOTTLETABLET, FILM COATED908
36800-458-87TopCare All Day Allergy300 in 1 BOTTLETABLET, FILM COATED3008
36800-458-87TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-95TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-95TopCare All Day Allergy45 in 1 BOTTLETABLET, FILM COATED458

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-458-06EA - Each36800-45842565974-eccf-46d3-b00f-0a8594d7949d12022-10-06
36800-458-13EA - Each36800-458cd1b29a2-1943-450c-aa45-1284d6b63c6212012-07-24
36800-458-39EA - Each36800-45890069031-2b64-4377-aae2-9c88d465369f12012-07-24
36800-458-47EA - Each36800-458fc0aa788-cf97-41e3-ad41-323ea21110a912012-07-24
36800-458-66EA - Each36800-458f1ff0d5b-ab4c-42ee-a7a1-344a5d9e21e412012-07-24
36800-458-72EA - Each36800-458596332a4-df67-403f-9eda-56d480b7797012012-07-24
36800-458-87EA - Each36800-45853c6f18c-d36d-44aa-ba05-fcff806a3dfd12012-07-24
36800-458-95EA - Each36800-458bb40b65f-5d29-430c-8186-a00639f5ea1112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOATOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]3
CETIRIZINEACTIVE MOIETYYO7261ME24TOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IETOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ETOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]3
TRIACETININACTIVE INGREDIENTXHX3C3X673TOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-458TOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 20 package rows20211201_f2919aad-9ed4-40b8-b233-4aec06df33ea.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
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
ndc (package): 36800-458-06
ndc (product): 36800-458
ndc11 (package): 36800045806
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNf2919aad-9ed4-40b8-b233-4aec06df33ea8
1014678cetirizine hydrochloride 10 MG Oral TabletSCDf2919aad-9ed4-40b8-b233-4aec06df33ea8
1014678cetirizine HCl 10 MG Oral TabletSYf2919aad-9ed4-40b8-b233-4aec06df33ea8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-458-06368000458061 BOTTLE in 1 CARTON (36800-458-06) > 70 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-03-200000-00-00NoNoCurrent