FDA.reportPublic FDA data

Dimetapp Cold and Cough and Nighttime Cold and Congestion

Product NDC
80070-350
11-digit product format
800700350
Labeler code
80070
Product ID
80070-350_4b83da33-2837-4fd6-e063-6394a90a3417
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
KIT
Labeler
Foundation Consumer Brands
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-15
Marketing end
2026-12-31
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dimetapp Cold and Cough and Nighttime Cold and Congestion

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1090463, 1236048, 1666116

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product 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
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80070-310-04Dimetapp Cold and Cough and Nighttime Cold and Congestion118 mL in 1 BOTTLEELIXIR118 mL1 mg in 5mL7
80070-310-04Dimetapp Cold and Cough and Nighttime Cold and Congestion1 in 1 CARTONELIXIR1 mg in 5mL7
80070-340-04Dimetapp Cold and Cough and Nighttime Cold and Congestion1 in 1 CARTONSOLUTION6.25 mg in 5mL7
80070-340-04Dimetapp Cold and Cough and Nighttime Cold and Congestion118 mL in 1 BOTTLESOLUTION118 mL2.5 mg in 5mL7
80070-350-08Dimetapp Cold and Cough and Nighttime Cold and Congestion1 in 1 CARTONKIT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80070-350DIMETAPP COLD AND COUGH AND NIGHTTIME COLD AND CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE) KIT [FOUNDATION CONSUMER BRANDS]6Current NDC, Legacy NDC, 5 package rows20240117_1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666116{1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } PackGPCK1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2467
16661161 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) PackPSN1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2467
1090463brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2467
1236048diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2467
1090463brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2467
1236048diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2467
16661161 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) PackSY1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2467
16661161 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) PackSY1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2467
1090463brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2467
1090463brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2467
1236048diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2467
1236048diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2467

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80070-310-0480070031004118 mL in 1 BOTTLE118 mlHistorical
80070-340-04800700340041 in 1 CARTONHistorical
80070-350-08800700350081 KIT in 1 CARTON (80070-350-08) * 1 BOTTLE in 1 CARTON (80070-340-04) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (80070-310-04) / 118 mL in 1 BOTTLE1 kit2021-09-152026-12-31NoNoCurrent