FDA.reportPublic FDA data

Allergy Relief

Product NDC
53943-130
Requested package NDC
53943-130-13
11-digit product format
539430130
Labeler code
53943
Product ID
53943-130_502476ab-e17d-bf5a-e063-6294a90a84fe
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DISCOUNT DRUG MART, INC
Application
ANDA078862
Marketing category
ANDA
Marketing start
2026-05-20
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 1.

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
A078862-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2009-02-19
A078862-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2009-02-19
A078862-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2009-02-19
A078862-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2009-02-19

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-19d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
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
4b9576dc-d7f9-dc10-e063-6294a90a233eAvailable 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
53943-130-13Allergy Relief1 in 1 CARTONTABLET, FILM COATED12
53943-130-13Allergy Relief30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
53943-130-17Allergy Relief1 in 1 CARTONTABLET, FILM COATED12
53943-130-17Allergy Relief60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefCETIRIZINE TABLETSDISCOUNT DRUG MART, INC4b9576dc-d7f9-dc10-e063-6294a90a233e2026-04-23WarningsExact identifier
application applno (ANDA): 078862
application number: ANDA078862
ndc (package): 53943-130-13
ndc (product): 53943-130
ndc11 (package): 53943013013
Hives ReliefCETIRIZINE TABLETSWALGREEN COMPANY4526b65c-b0e7-180c-e063-6394a90ae9162026-03-16WarningsExact identifier
application applno (ANDA): 078862
application number: ANDA078862
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBionpharma Inc.831d4141-b3be-4d98-a372-9c4d57ad296c2025-12-08WarningsExact identifier
application applno (ANDA): 078862
application number: ANDA078862

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN4b9576dc-d7f9-dc10-e063-6294a90a233e2
1014678cetirizine hydrochloride 10 MG Oral TabletSCD4b9576dc-d7f9-dc10-e063-6294a90a233e2
1014678cetirizine HCl 10 MG Oral TabletSY4b9576dc-d7f9-dc10-e063-6294a90a233e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53943-130-13539430130131 BOTTLE, PLASTIC in 1 CARTON (53943-130-13) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2026-05-20NoNoCurrent