FDA.reportPublic FDA data

Allergy Relief

Product NDC
59779-458
Requested package NDC
59779-458-01
11-digit product format
597790458
Labeler code
59779
Product ID
59779-458_131dd209-e1fe-4dd4-9523-8c0da50b78f4
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA078336
Marketing category
ANDA
Marketing start
2009-01-14
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
2027-12-31
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 · 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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-09-14 22:38:342026-08A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2784e616aacf4f…
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…

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
Allergy Relief
Brand name suffix
Indoor and Outdoor Allergies
Listing expiration
2027-12-31

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
98f3f2c6-da18-4055-81f1-962261360f9bAvailable 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
59779-458-00Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-00Allergy ReliefIndoor and Outdoor Allergies60 in 1 BOTTLETABLET, FILM COATED6014
59779-458-01Allergy ReliefIndoor and Outdoor Allergies2 in 1 CARTONTABLET, FILM COATED214
59779-458-05Allergy ReliefIndoor and Outdoor Allergies90 in 1 BOTTLETABLET, FILM COATED9014
59779-458-06Allergy ReliefIndoor and Outdoor Allergies70 in 1 BOTTLETABLET, FILM COATED7014
59779-458-06Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-13Allergy ReliefIndoor and Outdoor Allergies1 in 1 BLISTER PACKTABLET, FILM COATED114
59779-458-13Allergy ReliefIndoor and Outdoor Allergies5 in 1 CARTONTABLET, FILM COATED514
59779-458-39Allergy ReliefIndoor and Outdoor Allergies30 in 1 BOTTLETABLET, FILM COATED3014
59779-458-39Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-58Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-58Allergy ReliefIndoor and Outdoor Allergies40 in 1 BOTTLETABLET, FILM COATED4014
59779-458-66Allergy ReliefIndoor and Outdoor Allergies14 in 1 CARTONTABLET, FILM COATED1414
59779-458-66Allergy ReliefIndoor and Outdoor Allergies1 in 1 BLISTER PACKTABLET, FILM COATED114
59779-458-70Allergy ReliefIndoor and Outdoor Allergies2 in 1 CARTONTABLET, FILM COATED214
59779-458-70Allergy ReliefIndoor and Outdoor Allergies120 in 1 BOTTLETABLET, FILM COATED12014
59779-458-72Allergy ReliefIndoor and Outdoor Allergies2 in 1 CARTONTABLET, FILM COATED214
59779-458-72Allergy ReliefIndoor and Outdoor Allergies30 in 1 BOTTLETABLET, FILM COATED3014
59779-458-75Allergy ReliefIndoor and Outdoor Allergies90 in 1 BOTTLETABLET, FILM COATED9014
59779-458-75Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-76Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-76Allergy ReliefIndoor and Outdoor Allergies120 in 1 BOTTLETABLET, FILM COATED12014
59779-458-88Allergy ReliefIndoor and Outdoor Allergies365 in 1 BOTTLETABLET, FILM COATED36514
59779-458-88Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-95Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-95Allergy ReliefIndoor and Outdoor Allergies45 in 1 BOTTLETABLET, FILM COATED4514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-458-06EA - Each59779-45825de9fff-facc-4a33-bb36-0e59f1118cae12018-11-06
59779-458-13EA - Each59779-458341cf740-7f51-4ccf-a90f-3839cb396d7212018-11-06
59779-458-39EA - Each59779-4588872285d-8fd8-41ee-89b0-3f81756420cb12018-10-11
59779-458-66EA - Each59779-4582ee9b5da-ac29-4344-bf68-fdc7b066777012018-11-06
59779-458-70EA - Each59779-458eef30a01-286c-4ccd-b28f-e59565ca555612018-11-06
59779-458-72EA - Each59779-4589bd043f2-ba27-42bd-9691-cb333cdd444412022-06-06
59779-458-75EA - Each59779-458c68f1359-ac9d-42b4-bb63-9fdbba56eb3f12018-10-11
59779-458-76EA - Each59779-4585918cdf4-9b70-4108-baae-1d494cbefc6012018-10-11
59779-458-88EA - Each59779-45853c52fdd-9771-4c22-b05e-7e61475e893112017-03-06
59779-458-95EA - Each59779-458d819536e-bd42-4b1d-91fc-f6a414652f6b12018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]5
CETIRIZINEACTIVE MOIETYYO7261ME24ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]5
TRIACETININACTIVE INGREDIENTXHX3C3X673ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-458ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]11Current NDC, Legacy NDC, 26 package rows20230115_98f3f2c6-da18-4055-81f1-962261360f9b.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 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEProficient Rx LP198ca875-bb8a-49d5-8809-7121ba1193812022-04-01WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
rexall all day allergy reliefCETIRIZINE HYDROCHLORIDEDolgencorp, LLC4d79fb74-1895-4efe-8016-c0dd5ed10f7a2021-06-01WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
basic care all day allergyCETIRIZINE HYDROCHLORIDEAmazon.com Services LLCaf8ff570-8f72-4343-b7e1-e977221f5b012021-04-09WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN98f3f2c6-da18-4055-81f1-962261360f9b14
1014678cetirizine hydrochloride 10 MG Oral TabletSCD98f3f2c6-da18-4055-81f1-962261360f9b14
1014678cetirizine HCl 10 MG Oral TabletSY98f3f2c6-da18-4055-81f1-962261360f9b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59779-458-01597790458012 BOTTLE in 1 CARTON (59779-458-01) / 90 TABLET, FILM COATED in 1 BOTTLE (59779-458-05) 2 bottle2025-12-18NoNoCurrent