FDA.reportPublic FDA data

Allergy

Product NDC
68998-277
11-digit product format
689980277
Labeler code
68998
Product ID
68998-277_260b7a08-4f47-40ca-aa36-7647d20d7edd
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Marc Glassman, 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
Allergy
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
2051247f-ce64-4cf5-b449-9ca14c43ab86Available 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
68998-277-93Allergy1 in 1 CARTONTABLET, COATED16
68998-277-93Allergy24 in 1 BLISTER PACKTABLET, COATED246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68998-277ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET, COATED [MARC GLASSMAN, INC.]6Current NDC, Legacy NDC, 2 package rows20231018_2051247f-ce64-4cf5-b449-9ca14c43ab86.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 103 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
McKesson Sugar Free Cough Suppressant Oral AnestheticMENTHOL LOZENGEMcKesson Medical-Surgicale0dfa6ca-b311-25cb-e053-2a95a90a12cc2025-09-09WarningsExact identifier
application number: M012
Medique at Home Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione648f017-9e30-df6c-e053-2995a90adcd02025-09-09WarningsExact identifier
application number: M012
Medi-First Honey Lemon Cough DropsMENTHOL 8.6 MGUnifirst First Aid Corporation826e1b87-e5a9-8637-e053-2991aa0aded12025-09-09WarningsExact identifier
application number: M012
Unishield Cherry CoughMENTHOLUnishieldb8297bc1-44b2-3de0-e053-2995a90ad01b2025-09-09WarningsExact identifier
application number: M012
McKesson Cough SupressantMENTHOLMcKesson Medical-Surgicaldb5e0490-2ed8-2d53-e053-2a95a90a98f52025-09-09WarningsExact identifier
application number: M012
Duratuss ACCODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATEPoly Pharmaceuticals, Inc.3e5ed178-d5d9-b8d4-e063-6394a90a91db2025-09-09WarningsExact identifier
application number: M012
Rompe Pecho CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLEfficient Laboratories Inc96c4dee1-6e66-4442-a7e3-56e874414c172025-09-09WarningsExact identifier
application number: M012
Nighttime Cold and Flu Lil Drug Store ProductsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc57c458ed-7987-453b-ab24-bbfa6580f9202025-09-09WarningsExact identifier
application number: M012
equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.38637189-d1ee-9405-e063-6394a90ae8b82025-09-09WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreensfd52d8d8-7cd1-4e92-86da-354a1d5213c22025-09-08WarningsExact identifier
application number: M012
Green Guard Advanced Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione8e5fb21-a7fd-44d1-b9c4-83e949699ca62025-09-08WarningsExact identifier
application number: M012
Medi-First Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation9654f5cd-74d7-44a2-9674-666d1e94ffa72025-09-08WarningsExact identifier
application number: M012
Otis Clapp MygrexACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporationf196f2c5-a100-42b1-bd01-0327b223838e2025-09-08WarningsExact identifier
application number: M012
Medique DiphenDIPHENHYDRAMINE HYDROCHLORIDEUnifirst First Aid Corporationb61ee2e0-2543-447d-9fc4-23363d46ce042025-09-08WarningsExact identifier
application number: M012
Green Guard Allergy 2 ReliefPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation16fddca9-a66b-41e6-9423-eaf091d3971e2025-09-08WarningsExact identifier
application number: M012
Medique Medi-PhenylPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporationd7d62ac1-1333-4366-884b-26537766ce382025-09-08WarningsExact identifier
application number: M012
Unishield Sinus DecongestantPHENYLEPHRINE HCLUnishieldb8f68d9d-2d38-414a-e053-2a95a90a15ec2025-09-08WarningsExact identifier
application number: M012
McKesson Sinus Pain and Pressure ReliefACETAMINOPHEN, PHENYLEPHRINE HCLMcKesson Medical-Surgicale0cbb213-4f4f-4045-e053-2a95a90a2a182025-09-08WarningsExact identifier
application number: M012
Medique Medicidin DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation1f172d58-4050-424b-9743-130d8e618fe82025-09-08WarningsExact identifier
application number: M012
Medique Cold Cough ProductACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,Unifirst First Aid Corporatione8059137-efba-398c-e053-2a95a90a21f22025-09-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN2051247f-ce64-4cf5-b449-9ca14c43ab866
1363309chlorpheniramine maleate 4 MG Oral TabletSCD2051247f-ce64-4cf5-b449-9ca14c43ab866

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68998-277-93689980277931 BLISTER PACK in 1 CARTON (68998-277-93) / 24 TABLET, COATED in 1 BLISTER PACK1 blister pack2014-12-150000-00-00NoNoCurrent