FDA.reportPublic FDA data

First Aid Direct Cough Relief DM

Product NDC
42961-121
11-digit product format
429610121
Labeler code
42961
Product ID
42961-121_87824a21-c2c7-4af6-b55a-957676b01f06
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin dextromethorphan HBr
Dosage form
SYRUP
Route
ORAL
Labeler
Cintas Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-05-13
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42961-121-022023-07-28C16284748780-10191ceaa-64f6-198a-e063-dbdaa90aec3eFirst Aid Direct Cough Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42961-121-01First Aid Direct Cough Relief DM10 mL in 1 DOSE PACKSYRUP102
42961-121-02First Aid Direct Cough Relief DM6 in 1 BOXSYRUP62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-121FIRST AID DIRECT COUGH RELIEF DM (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [CINTAS CORPORATION]2Legacy NDC, 2 package rows20220811_d214b3e2-a626-42e9-a587-727b9017d62e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNd214b3e2-a626-42e9-a587-727b9017d62e2
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDd214b3e2-a626-42e9-a587-727b9017d62e2
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYd214b3e2-a626-42e9-a587-727b9017d62e2
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYd214b3e2-a626-42e9-a587-727b9017d62e2
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYd214b3e2-a626-42e9-a587-727b9017d62e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42961-121-014296101210110 mL in 1 DOSE PACK10 mlHistorical
42961-121-02429610121026 DOSE PACK in 1 BOX (42961-121-02) > 10 mL in 1 DOSE PACK (42961-121-01) 6 dose pack2022-05-130000-00-00NoNoCurrent