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 110 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
application number: M012
BroncofinDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMenper Distributors, Inc.fdf67382-1692-485b-92f1-2cbb8be4fb702025-07-22WarningsExact identifier
application number: M012
Defensol Adult SyrupGUAIFENESIN, DEXTROMETHORPHAN HBRMenper Distributors, Inc.62acff69-8c40-4a0e-8d56-be2cc14e3d452025-07-22WarningsExact identifier
application number: M012
Cosedal DropsDEXTROMETHORPHAN HBR, GUAIFENESINMenper Distributors, Inc.1241d249-ea3b-4d2b-87ed-835d6a2d286a2025-07-22WarningsExact identifier
application number: M012
Berro y Cebolla DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMenper Distributors, Inc.20107bd9-6d84-4ab5-a0d9-966f1f11d9192025-07-22WarningsExact identifier
application number: M012
Defensol-itoDEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINEMenper Distributors, Inca7c7a60d-d49f-4239-92f7-714eac7eb0c52025-07-22WarningsExact identifier
application number: M012
Bisolvine ChildrenGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.896a5443-e3d2-4af7-9e27-f1c1899ce0382025-07-22WarningsExact identifier
application number: M012
Bisolvine Aloe-MielDEXTROMETHORPHAN, GUAIFENESINMENPER DISTRIBUTORS INC.34801c79-ce88-492f-808e-b639e86016072025-07-22WarningsExact identifier
application number: M012
Viva Porru Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILMenper Distributors, Inc.0dfadfe3-9e40-0eee-e063-6294a90a00c32025-07-22WarningsExact identifier
application number: M012
leader childrens allergy reliefDIPHENHYDRAMINE HCLCardinal Health 110, LLC. dba Leader40d697b7-dc59-4d24-8d46-db635e01b9d52025-07-22WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEChain Drug Consortium34005c55-3176-4f28-9a3b-7dc6fefd01fe2025-07-19WarningsExact identifier
application number: M012
Sinus Relief Daytime NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company73a77a13-983b-4e65-bb3c-2ba5e9f33a3e2025-07-19WarningsExact identifier
application number: M012
QUALITY CHOICE No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)7cb6ad04-7847-46b9-b371-0a3473001c792025-07-18WarningsExact identifier
application number: M012
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLChain Drug Consortium270e9221-d305-4148-b523-741e02fe733f2025-07-18WarningsExact identifier
application number: M012
ACTISPEC PSEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC5def1555-87f4-41d5-8a5c-be560aa8f1e22025-07-17WarningsExact identifier
application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAYACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC1a17b24a-8022-4e2f-e063-6294a90af2762025-07-17WarningsExact identifier
application number: M012
BULPOL Smoking PatchesMENTHOLJiashen International Trade Limited3a1cc0e1-fabf-52b9-e063-6394a90ae35e2025-07-17WarningsExact identifier
application number: M012
Ampigrin Ultra Forte NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e71c3-fe7c-77c7-e053-2995a90a34b22025-07-17WarningsExact identifier
application number: M012
NitecinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCdfb56532-6f72-1e4d-e053-2a95a90a1c052025-07-17WarningsExact identifier
application number: M012
tabcin NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLC0b3ed2bb-88ed-699e-e063-6394a90ac0232025-07-17WarningsExact 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