FDA.reportPublic FDA data

Diabetic Tussin DM Maximum Strength

Product NDC
61787-515
11-digit product format
617870515
Labeler code
61787
Product ID
61787-515_e60166fa-5c2e-4449-9633-97607116cbe5
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
MEDTECH PRODUCTS INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/10mL; mg/10mL
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
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
Diabetic Tussin DM Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/10mL
GUAIFENESIN400 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046631Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a10a3b33-7503-4334-8ed7-2bb881df4327Available on FDA.report

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
61787-515-042024-01-30C16284748780-11030e365-31ea-111a-e063-dadaa90a10e2DiabeticTussin DM Max Strength 61787-515
61787-515-082024-01-30C16284748780-11030e365-31ea-111a-e063-dadaa90a10e2DiabeticTussin DM Max Strength 61787-515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61787-515-04Diabetic Tussin DM Maximum Strength1 in 1 BOXLIQUID15
61787-515-04Diabetic Tussin DM Maximum Strength118 mL in 1 BOTTLELIQUID1185
61787-515-08Diabetic Tussin DM Maximum Strength237 mL in 1 BOTTLELIQUID2375
61787-515-08Diabetic Tussin DM Maximum Strength1 in 1 BOXLIQUID15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61787-515-04ML - Milliliter61787-51505bf2819-f180-4d08-a680-36c26afd23e512022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61787-515DIABETIC TUSSIN DM MAXIMUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MEDTECH PRODUCTS INC]4Current NDC, Legacy NDC, 4 package rows20240704_a10a3b33-7503-4334-8ed7-2bb881df4327.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 152 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Black Cherry Cough DropsMENTHOLBoston Nutraceutical Production SL856f2e1a-2593-99e6-e053-2991aa0ad0392024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBoston Nutraceutical Production SL857363b6-e025-e074-e053-2a91aa0a43792024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBoston Nutraceutical Production SL857365ba-895e-4a63-e053-2991aa0a8b9f2024-10-07WarningsExact identifier
application number: M012
Menthol Vapor Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.La7062db1-8201-b400-e053-2a95a90a55e82024-10-07WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBoston Nutraceutical Production SLb8f48a47-6871-f7ed-e053-2995a90a16f32024-10-07WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBoston Nutraceutical Production SL856f0bd8-354b-a002-e053-2a91aa0a80222024-10-07WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBoston Nutraceutical Production SL83c4928a-eea6-e176-e053-2991aa0a6bb12024-10-07WarningsExact identifier
application number: M012
Natural Herbal Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.Lc2340f56-9a8e-4eea-e053-2995a90a78fc2024-10-07WarningsExact identifier
application number: M012
Natural Herbal Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.La706ee9c-9ed0-d3f1-e053-2a95a90a26d62024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff0b37b-6c08-b687-e053-2a95a90a11a92024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLCefcf2edd-21a3-45f9-e053-2995a90a38652024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff65505-8846-35c2-e053-2a95a90a6b792024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLCeff0fdfe-695a-4e62-e053-2a95a90ab50f2024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff1a70f-fa71-52b2-e053-2995a90a038c2024-10-07WarningsExact identifier
application number: M012
Honey Lemon Menthol Cough DropsHONEY LEMON MENTHOLTopco Associates LLCf5be283b-524d-26af-e053-2995a90a39722024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff16ba3-7e30-aa93-e053-2995a90a64cb2024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.ebf6bcf5-9384-052a-e053-2a95a90a30a52024-10-07WarningsExact identifier
application number: M012
Rompe Pecho SF Flu SF FluBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBREfficient Laboratories Inc06eac696-e8f6-ac50-e063-6394a90a2ed62024-10-07WarningsExact identifier
application number: M012
dg health nasal fourPHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCceeeb016-8e46-40b8-9923-8a4270475f452024-10-04WarningsExact identifier
application number: M012
Topcare Nasal FourPHENYLEPHRINE HYDROCHLORIDETopco Associates LLC99bc8829-167b-4cf8-8421-57da369f24cd2024-10-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046631dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 10 mL Oral SolutionPSNa10a3b33-7503-4334-8ed7-2bb881df43275
1046631dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML Oral SolutionSCDa10a3b33-7503-4334-8ed7-2bb881df43275
1046631dextromethorphan HBr 10 MG / guaifenesin 200 MG per 5 ML Oral SolutionSYa10a3b33-7503-4334-8ed7-2bb881df43275
1046631dextromethorphan HBr 20 MG / guaifenesin 400 MG per 10 ML Oral SolutionSYa10a3b33-7503-4334-8ed7-2bb881df43275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61787-515-04617870515041 BOTTLE in 1 BOX (61787-515-04) / 118 mL in 1 BOTTLE1 bottle2020-02-010000-00-00NoNoCurrent
61787-515-08617870515081 BOTTLE in 1 BOX (61787-515-08) / 237 mL in 1 BOTTLE1 bottle2020-02-010000-00-00NoNoCurrent