FDA.reportPublic FDA data

Equaline all day allergy

Product NDC
41163-458
11-digit product format
411630458
Labeler code
41163
Product ID
41163-458_6e7bab3d-af1a-4b74-921d-99aca2aa0fd3
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA078336
Marketing category
ANDA
Marketing start
2008-01-23
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41163-45841163-458-58DDiscontinued by firm2026-10-12
excluded packagepackage41163-45841163-458-76DDiscontinued by firm2026-10-12
excluded packagepackage41163-45841163-458-95DDiscontinued by firm2026-10-12

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 2025-12-0541163-458-58d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0541163-458-76d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0541163-458-95d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2641163-458-95f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2641163-458-58f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2641163-458-76f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3141163-458-952ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3141163-458-582ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3141163-458-762ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2841163-458-95a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2841163-458-58a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2841163-458-76a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2141163-458-95cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2141163-458-58cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2141163-458-76cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1041163-458-95cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1041163-458-58cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1041163-458-76cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3141163-458-95302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3141163-458-58302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3141163-458-76302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2041163-458-95ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2041163-458-58ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2041163-458-76ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1041163-458-950efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1041163-458-580efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1041163-458-760efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0841163-458-95ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0841163-458-58ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0841163-458-76ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0341163-458-95367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0341163-458-58367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0341163-458-76367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0941163-458-95557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0941163-458-58557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0941163-458-76557ba5c1ecfa…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…

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
Equaline 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
491fae66-83b6-4beb-945b-39b9e4e021c5Available 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
41163-458-39Equaline all day allergy30 in 1 BOTTLETABLET, FILM COATED309
41163-458-39Equaline all day allergy1 in 1 CARTONTABLET, FILM COATED19
41163-458-58Equaline all day allergy40 in 1 BOTTLETABLET, FILM COATED409
41163-458-58Equaline all day allergy1 in 1 CARTONTABLET, FILM COATED19
41163-458-66Equaline all day allergy14 in 1 CARTONTABLET, FILM COATED149
41163-458-66Equaline all day allergy1 in 1 BLISTER PACKTABLET, FILM COATED19
41163-458-72Equaline all day allergy1 in 1 CARTONTABLET, FILM COATED19
41163-458-72Equaline all day allergy60 in 1 BOTTLETABLET, FILM COATED609
41163-458-76Equaline all day allergy120 in 1 BOTTLETABLET, FILM COATED1209
41163-458-76Equaline all day allergy1 in 1 CARTONTABLET, FILM COATED19
41163-458-95Equaline all day allergy1 in 1 PACKAGETABLET, FILM COATED19
41163-458-95Equaline all day allergy45 in 1 BOTTLETABLET, FILM COATED459

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-458-39EA - Each41163-458efef2ed8-dbaa-45d0-9009-f7bf40a03c4f12012-07-24
41163-458-66EA - Each41163-4581145571e-187d-4c90-a65a-1d62af280cd612018-01-12
41163-458-72EA - Each41163-4582a6ddf8f-b9c6-4a82-a203-f7c899db91d512012-07-24
41163-458-76EA - Each41163-45888ebbce2-ff22-49c3-97cd-79bc0a95c08912012-07-24
41163-458-95EA - Each41163-4588ad88392-7fbb-4a48-8327-b6b3c2731a1a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAEQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [SUPERVALU INC]3
CETIRIZINEACTIVE MOIETYYO7261ME24EQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [SUPERVALU INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [SUPERVALU INC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [SUPERVALU INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [SUPERVALU INC]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEEQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [SUPERVALU INC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [SUPERVALU INC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EEQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [SUPERVALU INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJEQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [SUPERVALU INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [SUPERVALU INC]3
TRIACETININACTIVE INGREDIENTXHX3C3X673EQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [SUPERVALU INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-458EQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]8Current NDC, Legacy NDC, 12 package rows20230803_491fae66-83b6-4beb-945b-39b9e4e021c5.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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
CetirizineCETIRIZINE HYDROCHLORIDEA-S Medication Solutions88c3d23e-a0d8-4464-9414-666d74f11f662025-10-28WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
allergy reliefCETIRIZINE HYDROCHLORIDESafewayc5e74b2c-7871-4f28-a77d-0d674b9b8c5e2025-09-23WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Equaline all day allergyCETIRIZINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI491fae66-83b6-4beb-945b-39b9e4e021c52025-09-18WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (product): 41163-458
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc0827643a-29b8-487a-a158-28976d672d4d2025-09-12WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CareOne Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerican Sales Company533abfc1-226e-4a68-bfcc-ec046a4d57512025-08-25WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
good neighbor pharmacy all day allergyCETIRIZINE HYDROCHLORIDEAmerisource Bergenc568e388-60ab-47be-b362-7832b83d06ad2025-07-21WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
leader all day allergyCETIRIZINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf2025-07-21WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
24 hour allergyCETIRIZINE HYDROCHLORIDEMeijer Distribution Inc2b03c026-3e8a-4283-981f-965bc084c03d2025-07-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
kirkland signature aller tec allergyCETIRIZINE HYDROCHLORIDECostco Wholesale Companyd4a688aa-02d4-4af6-9a91-ed31679cfaf82025-06-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepackae93976d-de9b-43a6-b299-ce1f1ae8d6f82025-05-21WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd91fe3ab8-c155-4482-9f06-f029d3563aad2025-03-06WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC25db4ca0-0c25-f3b6-e063-6394a90a88512024-11-01WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Members Mark Allergy ReliefCETIRIZINE HYDROCHLORIDESam's West Inc379756fd-f92d-4773-94fd-2682fcbdfba22024-05-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.af7513ae-5107-477c-a7da-0ded9d53a55c2024-03-27WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutions2f562a13-8909-4107-b135-10333707bab32024-01-24WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsc1a208c8-2554-4e8e-b506-aeb8e417d4442024-01-24WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
betr remedies all day allergy reliefCETIRIZINE HYDROCHLORIDELive Betr LLC4a017852-db01-4085-8947-d92a19ec4e5c2023-05-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN491fae66-83b6-4beb-945b-39b9e4e021c59
1014678cetirizine hydrochloride 10 MG Oral TabletSCD491fae66-83b6-4beb-945b-39b9e4e021c59
1014678cetirizine HCl 10 MG Oral TabletSY491fae66-83b6-4beb-945b-39b9e4e021c59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-458-39411630458391 BOTTLE in 1 CARTON (41163-458-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-11-030000-00-00NoNoCurrent
41163-458-58411630458581 BOTTLE in 1 CARTON (41163-458-58) > 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-11-210000-00-00NoNoCurrent
41163-458-664116304586614 BLISTER PACK in 1 CARTON (41163-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2008-01-230000-00-00NoNoCurrent
41163-458-72411630458721 BOTTLE in 1 CARTON (41163-458-72) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-09-090000-00-00NoNoCurrent
41163-458-76411630458761 BOTTLE in 1 CARTON (41163-458-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-08-050000-00-00NoNoCurrent
41163-458-95411630458951 in 1 PACKAGEHistorical