Allergy Relief

Product NDC
79903-344
11-digit product format
799030344
Labeler code
79903
Product ID
79903-344_cba66cc9-b3ad-449c-af8b-5f5214c5d452
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
WALMART INC. (see also Equate)
Application
ANDA205291
Marketing category
ANDA
Marketing start
2025-03-31
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage79903-34479903-344-50DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage79903-34479903-344-50DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage79903-34479903-344-50DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A205291-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2017-07-21

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2184e616aacf4f…
2026-08-18 06:07:402026-07A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-213f01610625f2…
2019-09-15 20:21 UTC2019-09A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Listing expiration
2027-12-31

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
41bc1339-7137-4472-b47b-a7a36e24a9bbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-344-25Allergy Relief25 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED254
79903-344-25Allergy Relief1 in 1 BOXCAPSULE, LIQUID FILLED14
79903-344-50Allergy Relief25 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED254
79903-344-50Allergy Relief1 in 1 BOXCAPSULE, LIQUID FILLED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-344ALLERGY RELIEF (CETIRIZINE HCL) CAPSULE, LIQUID FILLED [WALMART INC. (SEE ALSO EQUATE)]4Current NDC, 4 package rows20250430_41bc1339-7137-4472-b47b-a7a36e24a9bb.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEStrides Pharma, Inc.29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba2026-08-24WarningsExact identifier
application applno (ANDA): 205291
application number: ANDA205291
Allergy ReliefCETIRIZINE HCLWALMART INC. (see also Equate)41bc1339-7137-4472-b47b-a7a36e24a9bb2025-04-29WarningsExact identifier
application applno (ANDA): 205291
application number: ANDA205291
ndc (product): 79903-344
All Day AllergyCETIRIZINE HCLCare One (American Sales Company)01d0729f-11ef-4ec5-8d8e-2863407c3f952025-04-07WarningsExact identifier
application applno (ANDA): 205291
application number: ANDA205291

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN41bc1339-7137-4472-b47b-a7a36e24a9bb4
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD41bc1339-7137-4472-b47b-a7a36e24a9bb4
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY41bc1339-7137-4472-b47b-a7a36e24a9bb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
79903-344-25799030344251 BOTTLE, PLASTIC in 1 BOX (79903-344-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2025-03-31NoNoCurrent
79903-344-507990303445025 in 1 BOTTLE, PLASTICHistorical