FDA.reportPublic FDA data

Allergy

Product NDC
0904-0012
11-digit product format
009040012
Labeler code
0904
Product ID
0904-0012_bcc8737e-6bf0-4d42-991f-0bdce5bbd875
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-12-19
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-0012-24Allergy2 in 1 CARTONTABLET225
0904-0012-24Allergy12 in 1 BLISTER PACKTABLET1225
0904-0012-59Allergy1 in 1 CARTONTABLET125
0904-0012-59Allergy100 in 1 BOTTLE, PLASTICTABLET10025
0904-0012-61Allergy10 in 1 BLISTER PACKTABLET1025
0904-0012-61Allergy10 in 1 CARTONTABLET1025
0904-0012-80Allergy1000 in 1 BOTTLE, PLASTICTABLET100025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-0012-24EA - Each0904-001218a08f0f-7a10-4ded-b696-89ff949ef91a12013-08-02
0904-0012-59EA - Each0904-001241cf3f5e-54c3-4819-9f98-441882d0f47c12013-08-02
0904-0012-61EA - Each0904-001215e3010e-94b9-46dd-883d-957f017c402512013-02-13
0904-0012-80EA - Each0904-001209b8fe40-cac3-4727-b7ff-7579715ad9f312013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]8
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]8
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZCHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZCHLORPHENIRAMINE MALEATE TABLET [DIRECT RX]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UCHLORPHENIRAMINE MALEATE TABLET [DIRECT RX]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UCHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCHLORPHENIRAMINE MALEATE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORPHENIRAMINE MALEATE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORPHENIRAMINE MALEATE TABLET [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLORPHENIRAMINE MALEATE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-0012ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]24Current NDC, Legacy NDC, 7 package rows20250306_66b918d3-5c37-4889-b981-819ced8b6147.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSNc948e612-a491-4ad0-adb9-cf31ef76e4d8104
1363309chlorpheniramine maleate 4 MG Oral TabletSCDc948e612-a491-4ad0-adb9-cf31ef76e4d8104
1363309chlorpheniramine maleate 4 MG Oral TabletPSN66b918d3-5c37-4889-b981-819ced8b614725
1363309chlorpheniramine maleate 4 MG Oral TabletSCD66b918d3-5c37-4889-b981-819ced8b614725
1363309chlorpheniramine maleate 4 MG Oral TabletPSNb199b5ee-fff3-4746-be68-a04060586f8e20
1363309chlorpheniramine maleate 4 MG Oral TabletSCDb199b5ee-fff3-4746-be68-a04060586f8e20
1363309chlorpheniramine maleate 4 MG Oral TabletPSN2dbd56d5-2bb5-4697-b7cb-e4c1543219973
1363309chlorpheniramine maleate 4 MG Oral TabletPSN4c59bf7c-eb93-4792-9326-0076e7c55c393
1363309chlorpheniramine maleate 4 MG Oral TabletSCD2dbd56d5-2bb5-4697-b7cb-e4c1543219973
1363309chlorpheniramine maleate 4 MG Oral TabletSCD4c59bf7c-eb93-4792-9326-0076e7c55c393
1363309chlorpheniramine maleate 4 MG Oral TabletPSN4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f1
1363309chlorpheniramine maleate 4 MG Oral TabletPSN59e179f8-acdb-4306-bd4f-24350d9171b11
1363309chlorpheniramine maleate 4 MG Oral TabletSCD4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f1
1363309chlorpheniramine maleate 4 MG Oral TabletSCD59e179f8-acdb-4306-bd4f-24350d9171b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-0012-24009040012242 BLISTER PACK in 1 CARTON (0904-0012-24) / 12 TABLET in 1 BLISTER PACK2 blister pack1992-12-190000-00-00NoNoCurrent
0904-0012-59009040012591 BOTTLE, PLASTIC in 1 CARTON (0904-0012-59) / 100 TABLET in 1 BOTTLE, PLASTIC1992-12-190000-00-00NoNoCurrent
0904-0012-610090400126110 BLISTER PACK in 1 CARTON (0904-0012-61) / 10 TABLET in 1 BLISTER PACK10 blister pack1992-12-190000-00-00NoNoCurrent
0904-0012-80009040012801000 TABLET in 1 BOTTLE, PLASTIC (0904-0012-80) 1000 tablet1992-12-190000-00-00NoNoCurrent