top care all day allergy

Product NDC
36800-180
11-digit product format
368000180
Labeler code
36800
Product ID
36800-180_6fe07c0a-a5f6-45dd-b67e-ea214d3870e3
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA207235
Marketing category
ANDA
Marketing start
2020-06-06
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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207235-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2016-08-12cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
top 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
1a217b8a-621a-4b6d-a7ed-37b04f829d66Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-180-09top care all day allergy65 in 1 BOTTLECAPSULE, LIQUID FILLED652
36800-180-09top care all day allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED12
36800-180-63top care all day allergy25 in 1 BOTTLECAPSULE, LIQUID FILLED252
36800-180-63top care all day allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-180TOP CARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 4 package rows20200619_1a217b8a-621a-4b6d-a7ed-37b04f829d66.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
ndc (product): 36800-180
24 hour allergyCETIRIZINE HYDROCHLORIDEMeijer Distribution Ince64db82c-6632-421e-8212-e0879445c4d62020-06-04WarningsExact identifier
application applno (ANDA): 207235
application number: ANDA207235

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN1a217b8a-621a-4b6d-a7ed-37b04f829d662
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD1a217b8a-621a-4b6d-a7ed-37b04f829d662
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY1a217b8a-621a-4b6d-a7ed-37b04f829d662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-180-09368000180091 BOTTLE in 1 PACKAGE (36800-180-09) / 65 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-06-080000-00-00NoNoCurrent
36800-180-63368000180631 BOTTLE in 1 PACKAGE (36800-180-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-06-060000-00-00NoNoCurrent