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 85 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores,Inc.,770c0e4f-0eed-4b8c-85a5-761b6a84db622025-12-02WarningsExact identifier
application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWAL-MART STORES INCa2a7e568-bff8-4818-a31d-7c2efa1859c32025-12-02WarningsExact identifier
application number: M012
DayTime Severe, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED TABLETLil' Drug Store Products, Inc.44fa0193-2a19-bdc1-e063-6394a90a60e82025-12-02WarningsExact identifier
application number: M012
Nighttime Severe, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.44fb9958-d771-f4b3-e063-6294a90a91352025-12-02WarningsExact identifier
application number: M012
Quality Choice Mucus ReliefGUAIFENESINChain Drug Marketing Associationf1a73da7-0dbb-49bd-857e-7dd6bc11b63c2025-12-02WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 70000ac74be47-30f0-418b-bd07-502feaa9723f2025-12-01WarningsExact identifier
application number: M012
Walgreens High Blood Pressure Cold and FluACETAMINOPHEN, DEXTROMETHORPHANWALGREENS CO.bc83b55e-c3d8-460f-8ef9-ff7b2e4f72722025-12-01WarningsExact identifier
application number: M012
Walgreen High Blood Pressure Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEWALGREENS CO.f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a2025-12-01WarningsExact identifier
application number: M012
Walgreens Nighttime Kids Honey Cold Cough CongestionDOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS COc0f317cd-723d-47f2-b600-aaeae63994822025-12-01WarningsExact identifier
application number: M012
Walgreen Maximum Strength Severe Congestion and coughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALGREENS CO.b4abcb6d-f3e1-4d63-98cf-ff556ec423b62025-12-01WarningsExact identifier
application number: M012
Walgreens Daytime ChildrensCOUGH AND CHEST CONGESTIONWALGREENS CO.dd99675f-3860-42ef-999c-d9a3746a38c02025-12-01WarningsExact identifier
application number: M012
Adult Cough plus Chest Congestion DM with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINWALGREEN COMPANY5f5af13a-c2a3-4bbe-880e-9c57b36e92342025-12-01WarningsExact identifier
application number: M012
Walgreens Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWALGREEN COMPANYb2e08f4d-9753-4767-a8eb-3740dd1034cc2025-12-01WarningsExact identifier
application number: M012
WALGREENS Cold Cough and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.1e903034-942e-4c6e-9f96-eb097c2665802025-12-01WarningsExact identifier
application number: M012
Walgreens DAY and NIGHT PACKDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATEWALGREEN COcb87e57b-ff06-4973-9751-137c7021e2722025-12-01WarningsExact identifier
application number: M012
WALGREEN Multi Symptom Flu Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWALGREENS CO.b7b1d604-921d-4ae7-93de-dcf690d421b42025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLMeijer Distribution Inc235b2866-bbda-7148-e063-6394a90a898f2025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWhole Foods Market, INC.32352109-31dc-8e6f-e063-6294a90a2f922025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.323347c3-d51a-4976-e063-6294a90a952e2025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWALGREEN COMPANY2969ba8f-c477-222a-e063-6394a90af7032025-12-01WarningsExact 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