FDA.reportPublic FDA data

Allergy Relief

Product NDC
67510-0159
11-digit product format
675100159
Labeler code
67510
Product ID
67510-0159_1cf99cf6-1836-4888-a5cc-f7ea5c6bb5f0
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORPHENIRAMINE MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
Kareway Product, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-18
Marketing end
0000-00-00
Substance
CHLORPHENIRAMINE MALEATE
Active strength
4 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
67510-0159-02019-11-27C16284748780-19855d018-e8d9-cd31-e053-dbdaa90ab51aDrug Facts
67510-0159-22019-11-27C16284748780-19855d018-e8d9-cd31-e053-dbdaa90ab51aDrug Facts
67510-0159-42019-11-27C16284748780-19855d018-e8d9-cd31-e053-dbdaa90ab51aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0159-0Allergy Relief10 in 1 BLISTER PACKTABLET104
67510-0159-0Allergy Relief2 in 1 BOXTABLET24
67510-0159-2Allergy Relief12 in 1 BLISTER PACKTABLET124
67510-0159-2Allergy Relief2 in 1 BOXTABLET24
67510-0159-4Allergy Relief12 in 1 BLISTER PACKTABLET124
67510-0159-4Allergy Relief4 in 1 BOXTABLET44

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
ETHANETHIOLINACTIVE INGREDIENTM439R54A1DALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0159ALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [KAREWAY PRODUCT, INC.]4Legacy NDC, 6 package rows20130407_2c6f254b-0453-4c79-8b3e-8373335b474e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN2c6f254b-0453-4c79-8b3e-8373335b474e4
1363309chlorpheniramine maleate 4 MG Oral TabletSCD2c6f254b-0453-4c79-8b3e-8373335b474e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67510-0159-06751001590010 in 1 BLISTER PACKHistorical
67510-0159-26751001590212 in 1 BLISTER PACKHistorical
67510-0159-46751001590412 in 1 BLISTER PACKHistorical