FDA.reportPublic FDA data

Cough and Cold HBP

Product NDC
83324-072
11-digit product format
833240072
Labeler code
83324
Product ID
83324-072_4912146b-4f66-4387-966c-0440eaf77209
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-03
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
4; 30 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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
Cough and Cold HBP
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1
DEXTROMETHORPHAN HYDROBROMIDE30 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
83324-072-16Cough and Cold HBP8 in 1 BLISTER PACKTABLET, FILM COATED84
83324-072-16Cough and Cold HBP2 in 1 CARTONTABLET, FILM COATED24
83324-072-24Cough and Cold HBP3 in 1 CARTONTABLET, FILM COATED34
83324-072-24Cough and Cold HBP8 in 1 BLISTER PACKTABLET, FILM COATED84

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-072-16EA - Each83324-0721ab2a410-25e7-4bea-95a0-728887f9342712026-04-20
83324-072-24EA - Each83324-0722b81855e-eb3b-4823-bc39-c6ca75952ffc12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-072COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.]3Current NDC, 4 package rows20241017_b00ec380-4e6e-4a3b-958c-50c75cff81a0.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 75 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Mucus Relief Cough Cherry LiquidDEXTROMETHORPHAN HBR, GUAIFENSINTopco Associates3170748e-b09f-4c07-9927-df43771166c52025-12-16WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe2025-12-16WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)e70d0784-53bc-4910-aade-3c9ad6e364412025-12-16WarningsExact identifier
application number: M012
Pain and SinusACETAMINOPHEN AND PHENYLEPHRINEJHK Inc dba American Safety & First Aid88f86f5a-cc2b-4c75-b7a4-f2021922280b2025-12-16WarningsExact identifier
application number: M012
Severe Congestion and Cough, Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Companyb75af815-9bd4-4a7a-bc68-f42f4af506992025-12-16WarningsExact identifier
application number: M012
Cough Relief NighttimeDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)fe5fd29e-7f81-4633-8c3b-010d68abe7012025-12-16WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLCe0a62fa1-9f8a-4770-b28b-1f4f02a762e02025-12-16WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company8c4b59b8-dfab-4f4a-9966-f07b026a758a2025-12-16WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)df866cf6-0526-4e61-ac9b-245b57dd5df62025-12-16WarningsExact identifier
application number: M012
Severe Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreensc89200b6-4adb-452e-b931-07f631dad6412025-12-16WarningsExact identifier
application number: M012
ONESSIP ADULT DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIMEDWISE LIFESCIENCES INC.45fa9159-d74c-063a-e063-6294a90a3ed02025-12-15WarningsExact identifier
application number: M012
SudoGest Nasal DecongestantPSEUDOEPHEDRINE HCLMajor Pharmaceuticals5229f4b2-a194-46f8-a0bc-4510fbe520752025-12-15WarningsExact identifier
application number: M012
Topcare NasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCf2b2467f-2d9b-4742-b90a-95975c3b694f2025-12-13WarningsExact identifier
application number: M012
Menthol Cough DropMENTHOLHEB39178eb7-ada9-30bf-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
SF Menthol Cough DropMENTHOLHEB3a443179-b7a6-3242-e054-00144ff8d46c2025-12-13WarningsExact identifier
application number: M012
Cherry cough dropMENTHOLHEB39bd0ca1-348f-0ce1-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
Strawberry Cough DropsMENTHOLHEB766236e2-3302-2232-e053-2991aa0af5032025-12-13WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLHEB3a30a427-6ab4-24ae-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
Mixed Berry Sore Throat and Cough LozengesBENZOCAINEHEB3063ea93-6bc2-1d18-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
HEB Menthol Cough DropsMENTHOLHEBc197855d-15b4-38fc-e053-2a95a90a2dc72025-12-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1421985chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Oral TabletPSNb00ec380-4e6e-4a3b-958c-50c75cff81a04
1421985chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Oral TabletSCDb00ec380-4e6e-4a3b-958c-50c75cff81a04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-072-16833240072162 BLISTER PACK in 1 CARTON (83324-072-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2024-07-03NoNoCurrent
83324-072-24833240072243 BLISTER PACK in 1 CARTON (83324-072-24) / 8 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2024-07-03NoNoCurrent