FDA.reportPublic FDA data

Allergy Relief

Product NDC
57896-974
11-digit product format
578960974
Labeler code
57896
Product ID
57896-974_08a1af20-70f6-8c75-e063-6394a90a5ec1
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate
Dosage form
TABLET
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-01
Substance
CHLORPHENIRAMINE MALEATE
Active strength
4 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

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Brand name suffix
4 Hour
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1Q0O9OJ9Z
Rxcui1363309

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57896-974-012021-02-15C16284748780-1ba0f9c33-3258-a910-e053-dadaa90a0b85HST 784 (974)
57896-974-102021-02-15C16284748780-1ba0f9c33-3258-a910-e053-dadaa90a0b85HST 784 (974)
57896-974-012021-01-29C16284748780-1ba0f9c33-3258-a910-e053-dadaa90a0b85HST 784 (974)
57896-974-102021-01-29C16284748780-1ba0f9c33-3258-a910-e053-dadaa90a0b85HST 784 (974)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-974-01Allergy Relief4 Hour100 in 1 BOTTLETABLET1004
57896-974-10Allergy Relief4 Hour1000 in 1 BOTTLETABLET10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-974ALLERGY RELIEF 4 HOUR (CHLORPHENIRAMINE MALEATE) TABLET [GERI-CARE PHARMACEUTICAL CORP]4Current NDC, Legacy NDC, 2 package rows20231027_92d90b41-0627-121e-e053-2995a90a2df1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN92d90b41-0627-121e-e053-2995a90a2df14
1363309chlorpheniramine maleate 4 MG Oral TabletSCD92d90b41-0627-121e-e053-2995a90a2df14
1363309chlorpheniramine maleate 4 MG Oral TabletPSN09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b1
1363309chlorpheniramine maleate 4 MG Oral TabletSCD09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-974-0157896097401100 TABLET in 1 BOTTLE (57896-974-01) 100 tablet2019-07-010000-00-00NoNoCurrent
57896-974-10578960974101000 TABLET in 1 BOTTLE (57896-974-10) 1000 tablet2019-07-010000-00-00NoNoCurrent