FDA.reportPublic FDA data

Equate

Product NDC
49035-276
11-digit product format
490350276
Labeler code
49035
Product ID
49035-276_3ff5b3ae-c55b-ee05-e063-6294a90ac323
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA090182
Marketing category
ANDA
Marketing start
2011-09-08
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
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

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 · 5 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage49035-276-02
excluded packagepackage49035-276-08
excluded packagepackage49035-276-09
excluded packagepackage49035-276-01

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
A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-04-22
A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-04-22

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-22782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/5mL

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
b73950f4-af6f-4dc7-bce2-9ec43c45eee5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
49035-276-012025-09-29Equate™ Children's Allergy Relief
49035-276-012025-09-29Equate™ Children's Allergy Relief
49035-276-022025-09-29Equate™ Children's Allergy Relief
49035-276-022025-09-29Equate™ Children's Allergy Relief
49035-276-082025-09-29Equate™ Children's Allergy Relief
49035-276-082025-09-29Equate™ Children's Allergy Relief
49035-276-092025-09-29Equate™ Children's Allergy Relief
49035-276-092025-09-29Equate™ Children's Allergy Relief
49035-276-012025-07-29Equate™ Children's Allergy Relief
49035-276-012025-07-29Equate™ Children's Allergy Relief
49035-276-022025-07-29Equate™ Children's Allergy Relief
49035-276-022025-07-29Equate™ Children's Allergy Relief
49035-276-082025-07-29Equate™ Children's Allergy Relief
49035-276-082025-07-29Equate™ Children's Allergy Relief
49035-276-092025-07-29Equate™ Children's Allergy Relief
49035-276-092025-07-29Equate™ Children's Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-276-01Equate Childrens Allergy Relief240 mL in 1 BOTTLESOLUTION2407
49035-276-01Equate Childrens Allergy Relief1 in 1 CARTONSOLUTION17
49035-276-02Equate Childrens Allergy Relief1 in 1 CARTONSOLUTION17
49035-276-02Equate Childrens Allergy Relief240 mL in 1 BOTTLESOLUTION2407
49035-276-08Equate Childrens Allergy Relief1 in 1 CARTONSOLUTION17
49035-276-08Equate Childrens Allergy Relief120 mL in 1 BOTTLESOLUTION1207
49035-276-09Equate Childrens Allergy Relief120 mL in 1 BOTTLESOLUTION1207
49035-276-09Equate Childrens Allergy Relief1 in 1 CARTONSOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-276-01ML - Milliliter49035-276037a4e81-ad4b-4417-a312-b981054fae1712017-06-15
49035-276-08ML - Milliliter49035-27638ce6ff4-dc26-4543-83b2-81374ddab5b212017-12-14
49035-276-09ML - Milliliter49035-27665c47ad4-357f-40de-9c5c-c47986400e1912024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOAEQUATE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]4
CetirizineACTIVE MOIETYYO7261ME24EQUATE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]4
acetic acidINACTIVE INGREDIENTQ40Q9N063PEQUATE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]4
glycerinINACTIVE INGREDIENTPDC6A3C0OXEQUATE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]4
methylparabenINACTIVE INGREDIENTA2I8C7HI9TEQUATE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3EQUATE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]4
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHEQUATE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]4
sodium acetate anhydrousINACTIVE INGREDIENTNVG71ZZ7P0EQUATE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]4
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4EQUATE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]4
waterINACTIVE INGREDIENT059QF0KO0REQUATE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-276EQUATE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]6Current NDC, Legacy NDC, 8 package rows20210413_b73950f4-af6f-4dc7-bce2-9ec43c45eee5.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb73950f4-af6f-4dc7-bce2-9ec43c45eee52026-06-12WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
ndc (product): 49035-276
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.30cbaa91-2216-efd2-e063-6294a90aaaed2026-06-07WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
HEB Allergy ReliefCETIRIZINE HYDROCHLORIDEH E B9abdae64-4c3d-47f3-8224-fc81f7bfe5572026-05-31WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEVERITYRX, LLC42a1168e-e2cd-a1e5-e063-6294a90ab3b62025-11-02WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
childrens allergyCETIRIZINE HYDROCHLORIDEPublix Super Markets Incae216d0b-8ccc-4cc4-82f4-4d0f3a2568222025-07-15WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Premier Value Childrens CetirizineCETIRIZINE HYDROCHLORIDEPharmacy Value Alliance LLCa4931f0b-86f2-42c5-b2df-b359bb46f44a2025-07-11WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC601c2846-30e7-40f1-96b4-64fbed719c0b2025-07-10WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.54d72d7a-1f5b-4b36-bf76-ab7aef6243ab2025-07-02WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
SIMPLY RIGHT childrens cetirizineCETIRIZINE HYDROCHLORIDESam's West Inc48b47541-cf0c-48a7-9a65-2158fd1284f12024-06-24WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEA-S Medication Solutions016b66fd-dde9-4f13-afaf-a8aafbdeed1a2024-01-23WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEProficient Rx LP582db483-394e-4c00-8522-4041a11696e42022-10-01WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEChain Drug Consortium, LLC (Premier Value)b47b0c8b-59d5-4e17-95be-a992c6861ee72019-01-23WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNb73950f4-af6f-4dc7-bce2-9ec43c45eee57
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDb73950f4-af6f-4dc7-bce2-9ec43c45eee57
1014673cetirizine HCl 1 MG/ML Oral SyrupSYb73950f4-af6f-4dc7-bce2-9ec43c45eee57
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYb73950f4-af6f-4dc7-bce2-9ec43c45eee57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-276-01490350276011 BOTTLE in 1 CARTON (49035-276-01) / 240 mL in 1 BOTTLE1 bottle2011-09-080000-00-00NoNoCurrent
49035-276-02490350276021 BOTTLE in 1 CARTON (49035-276-02) / 240 mL in 1 BOTTLE1 bottle2021-04-050000-00-00NoNoCurrent
49035-276-08490350276081 BOTTLE in 1 CARTON (49035-276-08) / 120 mL in 1 BOTTLE1 bottle2011-09-080000-00-00NoNoCurrent
49035-276-09490350276091 BOTTLE in 1 CARTON (49035-276-09) / 120 mL in 1 BOTTLE1 bottle2021-04-050000-00-00NoNoCurrent