FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAALLERGY RELIEF ALL DAY (CETIRIZINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
CETIRIZINEACTIVE MOIETYYO7261ME24ALLERGY RELIEF ALL DAY (CETIRIZINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLERGY RELIEF ALL DAY (CETIRIZINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF ALL DAY (CETIRIZINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY RELIEF ALL DAY (CETIRIZINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALLERGY RELIEF ALL DAY (CETIRIZINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EALLERGY RELIEF ALL DAY (CETIRIZINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLERGY RELIEF ALL DAY (CETIRIZINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
TALCINACTIVE INGREDIENT7SEV7J4R1UALLERGY RELIEF ALL DAY (CETIRIZINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY RELIEF ALL DAY (CETIRIZINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2

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

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