FDA.reportPublic FDA data

Exchange select all day allergy

Product NDC
55301-076
11-digit product format
553010076
Labeler code
55301
Product ID
55301-076_e61a6e00-ceae-4a3b-bbf8-ead4edc14d59
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Army & Air Force Exchange Service
Application
ANDA078336
Marketing category
ANDA
Marketing start
2016-05-13
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 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
Exchange select 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
e7220494-3640-4b33-b577-ed3ca7c483e8Available 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
55301-076-39Exchange select all day allergy30 in 1 BOTTLETABLET, FILM COATED305
55301-076-39Exchange select all day allergy1 in 1 CARTONTABLET, FILM COATED15
55301-076-95Exchange select all day allergy45 in 1 BOTTLETABLET, FILM COATED455
55301-076-95Exchange select all day allergy1 in 1 CARTONTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-076EXCHANGE SELECT ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [ARMY & AIR FORCE EXCHANGE SERVICE]4Current NDC, Legacy NDC, 4 package rows20201008_e7220494-3640-4b33-b577-ed3ca7c483e8.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
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 TabletPSNe7220494-3640-4b33-b577-ed3ca7c483e85
1014678cetirizine hydrochloride 10 MG Oral TabletSCDe7220494-3640-4b33-b577-ed3ca7c483e85
1014678cetirizine HCl 10 MG Oral TabletSYe7220494-3640-4b33-b577-ed3ca7c483e85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-076-39553010076391 BOTTLE in 1 CARTON (55301-076-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-08-290000-00-00NoNoCurrent
55301-076-95553010076951 BOTTLE in 1 CARTON (55301-076-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-05-130000-00-00NoNoCurrent