24 hour allergy

Product NDC
41250-618
11-digit product format
412500618
Labeler code
41250
Product ID
41250-618_6511653d-8712-4cd5-86bf-307042127dc7
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA207235
Marketing category
ANDA
Marketing start
2020-06-02
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 42.

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-123f01610625f2…
2019-09-15 20:21 UTC2019-09A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
24 hour 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
e64db82c-6632-421e-8212-e0879445c4d6Available 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
41250-618-6324 hour allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED12
41250-618-6324 hour allergy25 in 1 BOTTLECAPSULE, LIQUID FILLED252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-61824 HOUR ALLERGY (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MEIJER DISTRIBUTION INC]2Current NDC, Legacy NDC, 2 package rows20200616_e64db82c-6632-421e-8212-e0879445c4d6.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 · 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
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
ndc (product): 41250-618

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSNe64db82c-6632-421e-8212-e0879445c4d62
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCDe64db82c-6632-421e-8212-e0879445c4d62
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSYe64db82c-6632-421e-8212-e0879445c4d62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-618-63412500618631 BOTTLE in 1 PACKAGE (41250-618-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-06-020000-00-00NoNoCurrent