Allergy Relief

Product NDC
55910-129
11-digit product format
559100129
Labeler code
55910
Product ID
55910-129_04bf0fbc-f3ea-4690-9edc-66d047b85724
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
ANDA078780
Marketing category
ANDA
Marketing start
2013-05-17
Marketing end
2027-01-31
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078780-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2010-01-21
A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2010-01-21
A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2010-01-21
A078780-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2010-01-21

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078780-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-01-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078780-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2010-01-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078780-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2010-01-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078780-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-01-21d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Brand name suffix
All Day

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
27548729-7e2e-44cd-9a1d-70744f8b1df6Available 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
55910-129-45Allergy ReliefAll Day1 in 1 BOXTABLET18
55910-129-45Allergy ReliefAll Day45 in 1 BOTTLE, PLASTICTABLET458

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-129ALLERGY RELIEF ALL DAY (CETIRIZINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]7Current NDC, Legacy NDC, 2 package rows20221108_27548729-7e2e-44cd-9a1d-70744f8b1df6.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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
All Day Allergy ReliefCETIRIZINE HCLP & L Development, LLCa042d98d-35ad-4d40-8b27-79dafd0280962025-08-18WarningsExact identifier
application applno (ANDA): 078780
application number: ANDA078780
Allergy Relief All DayCETIRIZINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)27548729-7e2e-44cd-9a1d-70744f8b1df62025-07-01WarningsExact identifier
application applno (ANDA): 078780
application number: ANDA078780
ndc (product): 55910-129
Cetirizine Hydrochloride Hives ReliefCETIRIZINEAmneal Pharmaceuticals LLCaad39214-5bf1-427b-a00e-410224c51c952024-10-23WarningsExact identifier
application applno (ANDA): 078780
application number: ANDA078780
Cetirizine HydrochlorideCETIRIZINEAmneal Pharmaceuticals LLC214936a2-adc4-422a-a8fe-4c3ce9e01f362024-07-31WarningsExact identifier
application applno (ANDA): 078780
application number: ANDA078780
Cetirizine HydrochlorideCETIRIZINEAmneal Pharmaceuticals LLC273172b2-9aaf-46fb-a1ce-2961650eacd32024-07-31WarningsExact identifier
application applno (ANDA): 078780
application number: ANDA078780

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN27548729-7e2e-44cd-9a1d-70744f8b1df68
1014678cetirizine hydrochloride 10 MG Oral TabletSCD27548729-7e2e-44cd-9a1d-70744f8b1df68
1014678cetirizine HCl 10 MG Oral TabletSY27548729-7e2e-44cd-9a1d-70744f8b1df68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-129-45559100129451 BOTTLE, PLASTIC in 1 BOX (55910-129-45) / 45 TABLET in 1 BOTTLE, PLASTIC2013-05-172027-01-31NoNoCurrent