FDA.reportPublic FDA data

Allergy

Product NDC
0904-0012
11-digit product format
009040012
Labeler code
0904
Product ID
0904-0012_b4ea5878-6db7-4066-9ce9-02d6a334b581
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1363309Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
66b918d3-5c37-4889-b981-819ced8b6147Available on FDA.report

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

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 18 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus CongestionPHENYLEPHRINE HCLL.N.K. International, Inc.81f0276a-99a2-4a57-a0d8-224735aa8c792026-07-10WarningsExact identifier
application number: M012
SINUS AND HEADACHEACETAMINOPHEN, PHENYLEPHRINE HCLRite Aid Corporationefaf3be1-ab39-45f7-a45c-7fea8705c8d02026-07-10WarningsExact identifier
application number: M012
Equate Daytime Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.f847d9f2-aa47-4bbe-8f06-19356c6373982026-07-10WarningsExact identifier
application number: M012
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLTopco Associates, LLC2a80fba9-5e30-4ec0-bd8e-8957c0654b6c2026-07-10WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50230cad-3d04-8882-e063-6294a90acf3c2026-07-09WarningsExact identifier
application number: M012
Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLRugby Laboratoriesfc42e97d-1224-4d29-a55d-1a1885e0bf8f2026-07-09WarningsExact identifier
application number: M012
Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader7418d92d-a540-40d6-91d0-b7eb1f87f8ff2026-07-08WarningsExact identifier
application number: M012
DG HEALTH COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d2026-07-08WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLTopco Associates, LLCbfcabe02-7961-4407-a748-8cd0877313982026-07-08WarningsExact identifier
application number: M012
Aller-chlorCHLORPHENIRAMINE MALEATERugby Laboratories04ca3806-72be-47d4-9fea-5b0dee0876832026-07-08WarningsExact identifier
application number: M012
nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED24c22c9f-0c2f-46dc-850e-ed05f00d3e952026-07-08WarningsExact identifier
application number: M012
NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.0e65c5d1-a18b-452c-9be6-8d44d34577e92026-07-08WarningsExact identifier
application number: M012
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATECardinal Health 110, LLC. DBA Leaderaaecfda5-1a50-4d8a-9909-7153c1a22bda2026-07-08WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7cb9f378-5d64-475f-bf26-4058ba6c15b42026-07-08WarningsExact identifier
application number: M012
DG HEALTH DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp Incf174d08e-3335-4cc9-8766-4070f18c4f312026-07-08WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESIN 400 MGHealth Pharma USA LLCd60a3e9d-e88e-3b19-e053-2995a90a3e8d2026-07-07WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLCd38f47ea-7fda-170b-e053-2995a90adc822026-07-07WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINHealth Pharma USA LLCd68222f7-b796-7b27-e053-2995a90a2efe2026-07-07WarningsExact identifier
application number: M012
Cold and Flu Severe Day Time / Night TimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCacdcc6ce-c190-4de6-b126-62fe9043112e2026-07-07WarningsExact identifier
application number: M012
Calmco Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC471b1a43-1708-8be7-e063-6394a90a9bb72026-07-06WarningsExact identifier
application number: M012

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