Diabetic Tussin Nighttime Cold and Flu

Product NDC
61787-516
11-digit product format
617870516
Labeler code
61787
Product ID
61787-516_3f09d224-c1f3-43fc-a177-c3d4d84ae725
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, and Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
MEDTECH PRODUCTS INC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-02-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
650 mg/10mL; mg/10mL; mg/10mL
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61787-516-04Diabetic Tussin Nighttime Cold and Flu118 mL in 1 BOTTLELIQUID1183
61787-516-04Diabetic Tussin Nighttime Cold and Flu1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61787-516DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [MEDTECH PRODUCTS INC]3Legacy NDC, 2 package rows20220303_4d5e317f-0e32-4cdc-b56e-b792efa972f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094131acetaminophen 325 MG / dextromethorphan HBr 10 MG / diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN4d5e317f-0e32-4cdc-b56e-b792efa972f53
1094131acetaminophen 65 MG/ML / dextromethorphan hydrobromide 2 MG/ML / diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD4d5e317f-0e32-4cdc-b56e-b792efa972f53
1094131APAP 325 MG / dextromethorphan hydrobromide 10 MG / diphenhydramine hydrochloride 12.5 MG per 5 ML Oral SolutionSY4d5e317f-0e32-4cdc-b56e-b792efa972f53
1094131APAP 65 MG/ML / Dextromethorphan Hydrobromide 2 MG/ML / Diphenhydramine Hydrochloride 2.5 MG/ML Oral SolutionSY4d5e317f-0e32-4cdc-b56e-b792efa972f53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61787-516-04617870516041 BOTTLE in 1 CARTON (61787-516-04) > 118 mL in 1 BOTTLE1 bottle2020-02-010000-00-00NoNoCurrent