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

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

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-276-012025-09-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-012025-09-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-022025-09-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-022025-09-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-082025-09-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-082025-09-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-092025-09-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-092025-09-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-012025-07-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-012025-07-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-022025-07-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-022025-07-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-082025-07-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-082025-07-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-092025-07-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ Children's Allergy Relief
49035-276-092025-07-29C16284748780-13b156c62-3073-fb37-e063-e6dba90a4e07Equate™ 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#

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

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