FDA.reportPublic FDA data

rexall all day allergy relief

Product NDC
55910-699
11-digit product format
559100699
Labeler code
55910
Product ID
55910-699_eba98b0b-bc85-4d05-8875-86b85bd462b4
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dolgencorp, LLC
Application
ANDA078336
Marketing category
ANDA
Marketing start
2012-09-06
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 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
rexall all day 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
4d79fb74-1895-4efe-8016-c0dd5ed10f7aAvailable 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
55910-699-66rexall all day allergy relief1 in 1 CARTONTABLET, FILM COATED13
55910-699-66rexall all day allergy relief14 in 1 BLISTER PACKTABLET, FILM COATED143

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAREXALL ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]1
CETIRIZINEACTIVE MOIETYYO7261ME24REXALL ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDREXALL ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOREXALL ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XREXALL ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30REXALL ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEREXALL ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AREXALL ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EREXALL ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJREXALL ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPREXALL ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673REXALL ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-699REXALL ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [DOLGENCORP, LLC]3Current NDC, Legacy NDC, 2 package rows20210613_4d79fb74-1895-4efe-8016-c0dd5ed10f7a.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
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 TabletPSN4d79fb74-1895-4efe-8016-c0dd5ed10f7a3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD4d79fb74-1895-4efe-8016-c0dd5ed10f7a3
1014678cetirizine HCl 10 MG Oral TabletSY4d79fb74-1895-4efe-8016-c0dd5ed10f7a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-699-66559100699661 BLISTER PACK in 1 CARTON (55910-699-66) / 14 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2012-09-060000-00-00NoNoCurrent