FDA.reportPublic FDA data

Good Sense all day allergy

Product NDC
0113-9458
11-digit product format
001139458
Labeler code
0113
Product ID
0113-9458_c93a5e52-e438-4421-bdca-1fcfdcdb9b98
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA078336
Marketing category
ANDA
Marketing start
2008-01-16
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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0113-94580113-9458-04DDiscontinued by firm2026-09-14
excluded packagepackage0113-94580113-9458-13DDiscontinued by firm2026-09-14
excluded packagepackage0113-94580113-9458-58DDiscontinued by firm2026-09-14

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050113-9458-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050113-9458-58d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050113-9458-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260113-9458-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260113-9458-58f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260113-9458-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310113-9458-882ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310113-9458-582ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310113-9458-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280113-9458-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280113-9458-58a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280113-9458-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210113-9458-88cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210113-9458-58cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210113-9458-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100113-9458-88cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100113-9458-58cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100113-9458-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310113-9458-88302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310113-9458-58302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310113-9458-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200113-9458-88ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200113-9458-58ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200113-9458-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100113-9458-880efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100113-9458-580efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100113-9458-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080113-9458-88ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080113-9458-58ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080113-9458-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030113-9458-88367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030113-9458-58367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030113-9458-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090113-9458-88557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090113-9458-58557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090113-9458-04557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense all day allergy
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
2a7a27ab-1b4c-40d1-98bf-e4297aa25682Available 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
0113-9458-04Good Sense all day allergy5 in 1 VIALTABLET, FILM COATED511
0113-9458-13Good Sense all day allergy5 in 1 CARTONTABLET, FILM COATED511
0113-9458-13Good Sense all day allergy1 in 1 BLISTER PACKTABLET, FILM COATED111
0113-9458-39Good Sense all day allergy30 in 1 BOTTLETABLET, FILM COATED3011
0113-9458-39Good Sense all day allergy1 in 1 CARTONTABLET, FILM COATED111
0113-9458-58Good Sense all day allergy1 in 1 CARTONTABLET, FILM COATED111
0113-9458-58Good Sense all day allergy40 in 1 BOTTLETABLET, FILM COATED4011
0113-9458-66Good Sense all day allergy1 in 1 BLISTER PACKTABLET, FILM COATED111
0113-9458-66Good Sense all day allergy14 in 1 CARTONTABLET, FILM COATED1411
0113-9458-75Good Sense all day allergy90 in 1 BOTTLETABLET, FILM COATED9011
0113-9458-75Good Sense all day allergy1 in 1 CARTONTABLET, FILM COATED111
0113-9458-88Good Sense all day allergy30 in 1 BOTTLETABLET, FILM COATED3011
0113-9458-88Good Sense all day allergy1 in 1 CARTONTABLET, FILM COATED111
0113-9458-95Good Sense all day allergy45 in 1 BOTTLETABLET, FILM COATED4511
0113-9458-95Good Sense all day allergy1 in 1 CARTONTABLET, FILM COATED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-9458-13EA - Each0113-9458cf7ce490-8a09-4610-976d-28425420fca612012-07-24
0113-9458-39EA - Each0113-94587241261b-47b5-449a-929f-4b4552abcf8212012-07-24
0113-9458-66EA - Each0113-94581f2d29c1-02d7-4ce1-8c65-e53954659adc12012-07-24
0113-9458-75EA - Each0113-945850fe439d-3af3-484a-9c02-e3dd1a570c5112024-02-14
0113-9458-95EA - Each0113-9458f5598fec-8cf9-40ac-9085-38ccdf80c65112018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
CETIRIZINEACTIVE MOIETYYO7261ME24GOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
TRIACETININACTIVE INGREDIENTXHX3C3X673GOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-9458GOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [L. PERRIGO COMPANY]9Current NDC, Legacy NDC, 15 package rows20230531_2a7a27ab-1b4c-40d1-98bf-e4297aa25682.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
all day allergyCETIRIZINE HYDROCHLORIDERite Aid Corporationbcbb9f5a-10b6-4a5e-a237-d29693d781032026-09-04WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company678dcc09-55da-4d9d-a39a-c450c61c387b2026-08-18WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
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
ndc (product): 0113-9458
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN2a7a27ab-1b4c-40d1-98bf-e4297aa2568211
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2a7a27ab-1b4c-40d1-98bf-e4297aa2568211
1014678cetirizine HCl 10 MG Oral TabletSY2a7a27ab-1b4c-40d1-98bf-e4297aa2568211
1014678cetirizine HCl 10 MG Oral TabletPSN2f562a13-8909-4107-b135-10333707bab32
1014678cetirizine HCl 10 MG Oral TabletPSNc1a208c8-2554-4e8e-b506-aeb8e417d4442
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2f562a13-8909-4107-b135-10333707bab32
1014678cetirizine hydrochloride 10 MG Oral TabletSCDc1a208c8-2554-4e8e-b506-aeb8e417d4442
1014678cetirizine HCl 10 MG Oral TabletSY2f562a13-8909-4107-b135-10333707bab32
1014678cetirizine HCl 10 MG Oral TabletSYc1a208c8-2554-4e8e-b506-aeb8e417d4442
1014678cetirizine HCl 10 MG Oral TabletPSN0827643a-29b8-487a-a158-28976d672d4d1
1014678cetirizine hydrochloride 10 MG Oral TabletSCD0827643a-29b8-487a-a158-28976d672d4d1
1014678cetirizine HCl 10 MG Oral TabletSY0827643a-29b8-487a-a158-28976d672d4d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-9458-04001139458045 in 1 VIALHistorical
0113-9458-13001139458135 BLISTER PACK in 1 CARTON (0113-9458-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2008-01-300000-00-00NoNoCurrent
0113-9458-39001139458391 BOTTLE in 1 CARTON (0113-9458-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-10-280000-00-00NoNoCurrent
0113-9458-58001139458581 in 1 CARTONHistorical
0113-9458-660011394586614 BLISTER PACK in 1 CARTON (0113-9458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2008-01-160000-00-00NoNoCurrent
0113-9458-75001139458751 BOTTLE in 1 CARTON (0113-9458-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-05-10NoNoCurrent
0113-9458-88001139458881 BOTTLE in 1 CARTON (0113-9458-88) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-04-27NoNoCurrent
0113-9458-95001139458951 BOTTLE in 1 CARTON (0113-9458-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2010-04-080000-00-00NoNoCurrent