FDA.reportPublic FDA data

Dimetapp

Product NDC
69536-315
11-digit product format
695360315
Labeler code
69536
Product ID
69536-315_176beee1-c7df-3b47-e063-6394a90a398b
Type
HUMAN OTC DRUG
Nonproprietary name
BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Foundation Consumer Healthcare
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-01
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2; 10 mg/10mL; mg/10mL
Pharmacologic classes
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dimetapp
Brand name suffix
Cold and Cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIXA7C9ZN03, 9D2RTI9KYH
Rxcui2683421

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-315-04DimetappCold and Cough1 in 1 CARTONSOLUTION14
69536-315-04DimetappCold and Cough118 mL in 1 BOTTLESOLUTION1184
69536-315-08DimetappCold and Cough237 mL in 1 BOTTLESOLUTION2374
69536-315-08DimetappCold and Cough1 in 1 CARTONSOLUTION14
69536-315-04DimetappCold and Cough and Nighttime Cold and Cough1 in 1 CARTONSOLUTION2 mg in 10mL1
69536-315-04Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough1 in 1 CARTONSOLUTION2 mg in 10mL1
69536-315-04DimetappCold and Cough and Nighttime Cold and Cough118 mL in 1 BOTTLESOLUTION118 mL10 mg in 10mL1
69536-315-04Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough118 mL in 1 BOTTLESOLUTION236 mL10 mg in 10mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-315DIMETAPP COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [FOUNDATION CONSUMER HEALTHCARE]4Current NDC, 4 package rows20240601_176be362-5237-edd8-e063-6294a90a4aef.zip
69536-315DIMETAPP COLD AND COUGH AND DIMETAPP NIGHTTIME COLD AND COUGH (BROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE) KIT [FOUNDATION CONSUMER HEALTHCARE]1Current NDC20240601_1820e7c7-bc11-9061-e063-6394a90ae581.zip
69536-315DIMETAPP COLD AND COUGH AND NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE) KIT [FOUNDATION CONSUMER HEALTHCARE]1Current NDC20240601_179259a9-231e-df03-e063-6294a90a145e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG in 10 mL Oral SolutionPSN176be362-5237-edd8-e063-6294a90a4aef4
2683421brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD176be362-5237-edd8-e063-6294a90a4aef4
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG per 10 ML Oral SolutionSY176be362-5237-edd8-e063-6294a90a4aef4
2683422{1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML Oral Solution) } PackGPCK1820e7c7-bc11-9061-e063-6394a90ae5811
2683422{1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML Oral Solution) } PackGPCK179259a9-231e-df03-e063-6294a90a145e1
26834221 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG in 10 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG in 10 mL Oral Solution) PackPSN1820e7c7-bc11-9061-e063-6394a90ae5811
26834221 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG in 10 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG in 10 mL Oral Solution) PackPSN179259a9-231e-df03-e063-6294a90a145e1
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG in 10 mL Oral SolutionPSN179259a9-231e-df03-e063-6294a90a145e1
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG in 10 mL Oral SolutionPSN1820e7c7-bc11-9061-e063-6394a90ae5811
1049884diphenhydrAMINE HCl 50 MG in 40 mL Oral SolutionPSN179259a9-231e-df03-e063-6294a90a145e1
1049884diphenhydrAMINE HCl 50 MG in 40 mL Oral SolutionPSN1820e7c7-bc11-9061-e063-6394a90ae5811
2683421brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD179259a9-231e-df03-e063-6294a90a145e1
2683421brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD1820e7c7-bc11-9061-e063-6394a90ae5811
1049884diphenhydramine hydrochloride 1.25 MG/ML Oral SolutionSCD179259a9-231e-df03-e063-6294a90a145e1
1049884diphenhydramine hydrochloride 1.25 MG/ML Oral SolutionSCD1820e7c7-bc11-9061-e063-6394a90ae5811
26834221 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG per 10 mL Oral Solution) / 1 nighttime (diphenhydramine HCl 12.5 MG per 10 mL Oral Solution) PackSY179259a9-231e-df03-e063-6294a90a145e1
26834221 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG per 10 mL Oral Solution) / 1 nighttime (diphenhydramine HCl 12.5 MG per 10 mL Oral Solution) PackSY1820e7c7-bc11-9061-e063-6394a90ae5811
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG per 10 ML Oral SolutionSY179259a9-231e-df03-e063-6294a90a145e1
2683421brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG per 10 ML Oral SolutionSY1820e7c7-bc11-9061-e063-6394a90ae5811
1049884diphenhydramine hydrochloride 50 MG per 40 ML Oral SolutionSY179259a9-231e-df03-e063-6294a90a145e1
1049884diphenhydramine hydrochloride 50 MG per 40 ML Oral SolutionSY1820e7c7-bc11-9061-e063-6394a90ae5811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69536-315-04695360315041 BOTTLE in 1 CARTON (69536-315-04) / 118 mL in 1 BOTTLE1 bottle2024-06-01NoNoCurrent
69536-315-08695360315081 BOTTLE in 1 CARTON (69536-315-08) / 237 mL in 1 BOTTLE1 bottle2024-06-01NoNoCurrent