FDA.reportPublic FDA data

Allergy Relief

Product NDC
83324-068
11-digit product format
833240068
Labeler code
83324
Product ID
83324-068_5906235b-4f37-49ea-b449-6bbf1cc93b1b
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-10
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 Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1

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
83324-068-24Allergy Relief2 in 1 CARTONTABLET23
83324-068-24Allergy Relief12 in 1 BLISTER PACKTABLET123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-068-24EA - Each83324-0686a3b3495-4e85-42c4-8da1-db1dadb4717912026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-068ALLERGY RELIEF (CHLORPHENIRAMINE MALEATE) TABLET [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Current NDC, 2 package rows20240913_68bda134-0a6c-431c-be2e-cbcfcfb35bd7.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 91 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINSafeway, Inc.6fefff08-13b0-47eb-aa32-8d7e4deeae7b2025-11-05WarningsExact identifier
application number: M012
Menthol Drops Freegells Extra Strong Eucalyptus 30ctMENTHOLR.L. ALBERT & SON, INC165a8efa-2b03-4329-99fa-3233f0af7d082025-11-04WarningsExact identifier
application number: M012
Menthol Drops Freegells Extra Strong Honey Lemon 30ctMENTHOLR.L. ALBERT & SON, INCf9ea46fc-0b04-444e-95fc-09aff7e7978a2025-11-04WarningsExact identifier
application number: M012
QUALITY CHOICE Maximum Strength Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.40413cdb-68ac-70e1-e063-6394a90a92172025-11-04WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC73fec783-1594-447b-b059-49ea9dbb5bee2025-11-04WarningsExact identifier
application number: M012
Texaclear Fast Acting Allergy ReliefCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATEGM Pharmaceuticals, INC17a2f643-fa98-21ee-e054-00144ff88e882025-11-03WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e618bc7-0f51-e586-e063-6294a90afe372025-11-03WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e61b5b3-ad15-01bf-e063-6394a90a6ec32025-11-03WarningsExact identifier
application number: M012
Cold plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC409540c0-1bab-9969-e063-6394a90a47c12025-11-03WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e60b340-bd60-9318-e063-6294a90ad0792025-11-03WarningsExact identifier
application number: M012
Sinus Pressure and Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e60e32f-3e5f-b775-e063-6294a90a097d2025-11-03WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e614265-b35a-5d01-e063-6294a90aad852025-11-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60b0ed-889d-0f17-e063-6394a90a46942025-11-03WarningsExact identifier
application number: M012
VANACOF DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGM Pharmaceuticals, INC2ed699f2-d004-4fa9-8042-6c85a9ff69b62025-11-03WarningsExact identifier
application number: M012
Geri DrylDIPHENHYDRAMINE HCLVERITYRX, LLC42a05f69-0599-5571-e063-6394a90a37d32025-11-02WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEVERITYRX, LLC42a0e577-a1b6-2c16-e063-6294a90af8e32025-11-02WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corpc296efd0-5030-4a26-a9b0-e66423d995dc2025-10-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Max Maximum Strength SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTopco Associates, LLCf7ebe482-cb22-4517-8463-3432cf60071d2025-10-31WarningsExact identifier
application number: M012
Nighttime Cold and Flu Max SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates, LLC787bff76-0ee2-4e7e-b908-876e4a3e3bfc2025-10-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLTrader Joe's Company647dadae-f37a-8399-e053-2991aa0aedb32025-10-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN68bda134-0a6c-431c-be2e-cbcfcfb35bd73
1363309chlorpheniramine maleate 4 MG Oral TabletSCD68bda134-0a6c-431c-be2e-cbcfcfb35bd73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-068-24833240068242 BLISTER PACK in 1 CARTON (83324-068-24) / 12 TABLET in 1 BLISTER PACK2 blister pack2024-09-10NoNoCurrent