FDA.reportPublic FDA data

basic care all day allergy

Product NDC
72288-007
11-digit product format
722880007
Labeler code
72288
Product ID
72288-007_c3e987c5-7ca1-4514-aa0a-6668ff2937c5
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA207235
Marketing category
ANDA
Marketing start
2022-01-04
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
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207235-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2016-08-12

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 22:54:322026-06A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
All Day Allergy ReliefCETIRIZINE HCLP & L Development, LLC0fb52421-a327-4747-880f-d2b7608ccd652025-11-17WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235
Allergy ReliefCETIRIZINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)d1703629-a641-403f-b547-032a75489d092025-07-01WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235
basic care all day allergyCETIRIZINE HYDROCHLORIDEAmazon.com Services LLCc3e987c5-7ca1-4514-aa0a-6668ff2937c52022-01-04WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235
ndc (product): 72288-007
CareOne Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerican Sales Company833e8904-d37d-4478-af7c-8287f2d079a72021-08-16WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235
dg health all day allergyCETIRIZINE HYDROCHLORIDEDolgencorp, LLCba7d3995-c992-457c-a628-f036d77cc6382021-06-01WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235
top care all day allergyCETIRIZINE HYDROCHLORIDETopco Associates LLC1a217b8a-621a-4b6d-a7ed-37b04f829d662020-06-08WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235
24 hour allergyCETIRIZINE HYDROCHLORIDEMeijer Distribution Ince64db82c-6632-421e-8212-e0879445c4d62020-06-04WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235

Additional Listing Data#

Finished product
Yes
Brand name base
basic care all day allergy
Listing expiration
2026-12-31

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
1014675Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c3e987c5-7ca1-4514-aa0a-6668ff2937c5Available 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
72288-007-49basic care all day allergy1 in 1 CARTONCAPSULE, LIQUID FILLED12
72288-007-49basic care all day allergy40 in 1 BOTTLECAPSULE, LIQUID FILLED402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-007BASIC CARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AMAZON.COM SERVICES LLC]2Current NDC, Legacy NDC, 2 package rows20220106_c3e987c5-7ca1-4514-aa0a-6668ff2937c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSNc3e987c5-7ca1-4514-aa0a-6668ff2937c52
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCDc3e987c5-7ca1-4514-aa0a-6668ff2937c52
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSYc3e987c5-7ca1-4514-aa0a-6668ff2937c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-007-49722880007491 BOTTLE in 1 CARTON (72288-007-49) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-01-040000-00-00NoNoCurrent