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 125 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HCLMECLIZINE HCL 25MG CHEWABLE TABLETSAphena Pharma Solutions - Tennessee, LLC02d1af4d-d97d-4019-a5bf-3ec3912386762025-01-09WarningsExact identifier
application number: M012
HISTEX PD Drops New FormulationTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC0c693f15-5d76-3dbf-e063-6294a90af9ac2025-01-08WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HBR 15 MGDEXTROMETHORPHAN HBR 15 MGAMZ789 LLCe2175017-6a0d-0155-e053-2995a90a65d62025-01-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRHealth Pharma USA LLC29bb7822-76c6-e39d-e063-6294a90a64fb2025-01-07WarningsExact identifier
application number: M012
Childrens Allergy ReliefCHILDRENS ALLERGY RELIEFAllegiant Healthcb6df361-b8e5-4e2f-945f-c20159d76c4f2025-01-06WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLWinCo Foods, LLCbb7a9fed-dc04-4c31-aa7f-4185d955242c2025-01-06WarningsExact identifier
application number: M012
Leader Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leader207b2677-aaad-4fe4-a96d-963b7dcfba702025-01-06WarningsExact identifier
application number: M012
Allergy Relief CapletDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC126c05e7-2cd9-47d3-96c3-82305714e1db2025-01-02WarningsExact identifier
application number: M012
Right Remedies Adult Long Lasting Cough Relief SoftgelDEXTROMETHORPHAN HYDROBROMIDEStrive Pharmaceuticals Inc.e3ea468e-4e12-4dae-b222-8e32456b77b82025-01-02WarningsExact identifier
application number: M012
AVON HeXashield Congestion Relief OriginalOXYMETAZOLINE HYDROCHLORIDETai Guk Pharm. Co., Ltd.8f2c152c-c564-0cba-e053-2a95a90ab3c72025-01-01WarningsExact identifier
application number: M012
Multi-Symptom Nighttime Cold and Flu ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRAdvanced Rx LLCa75553bd-f3f0-47bd-b3c3-aeeb0d1a81b42025-01-01WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HYDROBROMIDEAdvanced Rx LLC297e10e3-e740-4434-91a2-2e5c54985d332025-01-01WarningsExact identifier
application number: M012
MUCUS RELIEF DMGUAIFENESIN, DEXTROMETHORPHAN HBRAdvanced Rx LLC64620186-a45b-4c35-a3b9-a347348f93f72025-01-01WarningsExact identifier
application number: M012
DM MaxDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice57a44bbf-a304-47b9-8adc-4442c77878532025-01-01WarningsExact identifier
application number: M012
Long Acting Cough SoftgelsDEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY, INC322daee6-c61d-43d3-a54d-a354fd3df2422025-01-01WarningsExact identifier
application number: M012
Adult Tussin DM Lil Drug Store ProductsDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINLil' Drug Store Products, Inc1915cf2a-ebaa-4c47-8991-5b741fa01be22024-12-31WarningsExact identifier
application number: M012
Congestion Relief Lil Drug Store ProductsOXYMETAZOLINE HYDROCHLORIDELil' Drug Store Products, Inc8fca348c-ecb6-4a91-89dd-8bd4c05ac7452024-12-31WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU MULTI SYMPTOMDAYTIME COLD AND FLU MULTI SYMPTOMTARGET CORP9dea350d-2f09-b944-e053-2995a90a2b632024-12-30WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreens2b7aa3f5-3bc9-471f-8ff7-3c52719f0acb2024-12-30WarningsExact identifier
application number: M012
Pediacare Childrens Cough and Cold GrapeBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTHfabafdc1-9dd8-4258-af49-bab1e29ad1092024-12-30WarningsExact 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