FDA.reportPublic FDA data

Chlorpheniramine maleate 4mg

Product NDC
53185-277
11-digit product format
531850277
Labeler code
53185
Product ID
53185-277_3bbe161c-4342-40b5-82b6-5270ef0e31d3
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate 4mg
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Athlete's Needs, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-15
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

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
Chlorpheniramine maleate 4mg
Listing expiration
2026-12-31

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
4d974959-25fc-4707-9b72-9afbf47b76f1Available 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
53185-277-24Chlorpheniramine maleate 4mg24 in 1 BOTTLETABLET, COATED246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53185-277CHLORPHENIRAMINE MALEATE 4MG TABLET, COATED [ATHLETE'S NEEDS, INC.]6Current NDC, Legacy NDC, 1 package rows20231020_4d974959-25fc-4707-9b72-9afbf47b76f1.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 172 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEMajor Pharmaceuticalsbcc1a001-4176-485d-aaf0-2037ca65c6b82023-12-14WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEMajor Pharmaceuticalsedb49b17-06a7-4c25-bc7c-d62c1deac7f12023-12-13WarningsExact identifier
application number: M012
Family Wellness Oxymetazoline No DripOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)0c006b1c-8ab2-4b9c-8738-e7001c1bb47d2023-12-11WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN,/ ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETARGET CORP0b1e230d-4354-bf61-e063-6394a90a2b2f2023-12-09WarningsExact identifier
application number: M012
Phenylephrine HCl Maximum StrengthPHENYLEPHRINE HCLA-S Medication Solutionsfcb769d0-aa45-48eb-acd0-2247b392f9fe2023-12-09WarningsExact identifier
application number: M012
Daytime and Nighttime Severe Honey Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0bf915af-a016-0a46-e063-6394a90aacf52023-12-08WarningsExact identifier
application number: M012
Maximum Strength Daytime Severe and Nighttime Cold and FluDAYTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, NIGHTTIME - ACETAMINOPHEN, DIPHENHYDRAMINE HCITARGET Corporation0bf9c0df-7676-3060-e063-6394a90a16c72023-12-08WarningsExact identifier
application number: M012
NazalNAPHAZOLINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.4d4043f8-5ed3-4027-beb6-687db13082022023-12-06WarningsExact identifier
application number: M012
Family Wellness OxymetazolineOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)8b4557d4-74a0-400f-ad7a-6d31473b3c672023-12-06WarningsExact identifier
application number: M012
Childrens Plus FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCIDolgencorp, Inc. (DOLLAR GENERAL & REXALL)1598e6f8-08ee-4216-a5ab-76cad37b09a72023-12-06WarningsExact identifier
application number: M012
Welmedix HomeCare PRO Fragile Skin ProtectantPETROLATUMWelmedix LLC6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf2023-12-05WarningsExact identifier
application number: M012
Welmedix HomeCare PRO Extra Strength Rapid Rash ReliefPETROLATUM, ZINC OXIDEWelmedix LLC551e6cce-7adc-4e98-baff-2703b83d75262023-12-05WarningsExact identifier
application number: M012
Stona-SACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc12023-12-04WarningsExact identifier
application number: M012
Stona CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.afc95c82-18da-487b-b4bb-51e0be0378da2023-12-04WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYWalgreens Companya14643a1-3d91-491a-88d6-22dccde979382023-12-04WarningsExact identifier
application number: M012
TopCare Day Time SEVERE Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC14d53907-a4a2-4a0f-b2d6-33474945f9e12023-12-04WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLProficient Rx LP62934d0f-b23d-4c03-9d60-a7bad41f9b422023-12-01WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEProficient Rx LPb1c849e5-8003-4fd3-811d-6a927523e3532023-12-01WarningsExact identifier
application number: M012
Akin Expectorant Formula Strawberry BananaGUAIFENESINSouthern Sales & Service, Inc.b63b0133-d2da-432b-a154-9e77535bbef92023-11-29WarningsExact identifier
application number: M012
Akin Cough Formula DM Strawberry BananaDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSouthern Sales & Service, Inc.7a81efd8-775d-455e-860f-f3e3b369a0a72023-11-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN4d974959-25fc-4707-9b72-9afbf47b76f16
1363309chlorpheniramine maleate 4 MG Oral TabletSCD4d974959-25fc-4707-9b72-9afbf47b76f16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53185-277-245318502772424 TABLET, COATED in 1 BOTTLE (53185-277-24) 2014-12-150000-00-00NoNoCurrent