FDA.reportPublic FDA data

CHILDRENS ALLERGY RELIEF

Product NDC
55315-354
11-digit product format
553150354
Labeler code
55315
Product ID
55315-354_17d2db07-4de0-4e02-8e2e-0082c275faab
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Fred's, Inc.
Application
ANDA090750
Marketing category
ANDA
Marketing start
2015-01-31
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2010-02-02
A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2010-02-02

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-02a50c72e98297…
2026-08-01 22:54:322026-06A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-02a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEAurohealth LLC52dc28ac-4059-4b6c-8bbc-22aa479a549a2026-03-09WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750
Childrens Cetirizine Hydrochloride AllergyCETIRIZINE HYDROCHLORIDEAurohealth LLC4de4f544-79cd-4a89-aafb-f2e2688b3c812026-03-09WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750
Childrens Cetirizine Hydrochloride Hives ReliefCETIRIZINE HYDROCHLORIDEAurohealth LLCbd489217-bf7c-429b-a58c-426104f7e7792025-12-16WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750
Childrens Cetirizine Hydrochloride Hives ReliefCETIRIZINE HYDROCHLORIDEAurohealth LLCe000848a-8bbe-4149-bdcb-d7b4b0bd4d0d2025-12-09WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEFred's, Inc.55e799b2-e325-4286-aa9a-b88e99ab11462020-12-13WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750
ndc (product): 55315-354
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEC.D.M.A., Inc.b4feed95-86ca-411c-99b5-773e485e752f2020-12-13WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750

Additional Listing Data#

Finished product
Yes
Brand name base
CHILDRENS ALLERGY RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE1 mg/mL

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
1014673Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55e799b2-e325-4286-aa9a-b88e99ab1146Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55315-354-31CHILDRENS ALLERGY RELIEF120 mL in 1 BOTTLESOLUTION1205
55315-354-31CHILDRENS ALLERGY RELIEF1 in 1 CARTONSOLUTION15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.]1
CETIRIZINEACTIVE MOIETYYO7261ME24CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55315-354CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.]5Current NDC, Legacy NDC, 2 package rows20201215_55e799b2-e325-4286-aa9a-b88e99ab1146.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN55e799b2-e325-4286-aa9a-b88e99ab11465
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD55e799b2-e325-4286-aa9a-b88e99ab11465
1014673cetirizine HCl 1 MG/ML Oral SyrupSY55e799b2-e325-4286-aa9a-b88e99ab11465
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY55e799b2-e325-4286-aa9a-b88e99ab11465

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55315-354-31553150354311 BOTTLE in 1 CARTON (55315-354-31) / 120 mL in 1 BOTTLE1 bottle2015-01-310000-00-00NoNoCurrent