FDA.reportPublic FDA data

Tussin Cough DM

Product NDC
63868-869
11-digit product format
638680869
Labeler code
63868
Product ID
63868-869_edb2c356-8242-4906-a79f-21a1306dd93f
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-31
Marketing end
2026-12-28
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 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
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
Tussin Cough DM
Brand name suffix
Sugar Free

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/10mL
GUAIFENESIN200 mg/10mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-869-04Tussin Cough DMSugar Free1 in 1 BOXLIQUID15
63868-869-04Tussin Cough DMSugar Free118 mL in 1 BOTTLE, PLASTICLIQUID1185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-869-04ML - Milliliter63868-86934dbf0e2-2331-45ec-ad23-11d6a8c4521d12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-869TUSSIN COUGH DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5Current NDC, Legacy NDC, 2 package rows20240502_5187c0c9-83a3-452e-aceb-95f24fc20e92.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 16 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLWinCo Foods, LLC2cbf27b6-217c-46d8-89c9-e46f3668f0022026-07-17WarningsExact identifier
application number: M012
Best ChoiceOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)d86d53cd-75ce-4c40-83cb-ada9b77a76f62026-07-17WarningsExact identifier
application number: M012
LEADER Multi Symptom Flu Relief Daytime Max StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBRCARDINAL HEALTH 110, LLC. DBA LEADER2212cf9e-6944-4922-b5b5-1373cf10b2e12026-07-16WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATECVS PHARMACY06756130-1608-4ae6-9772-95a4549853a12026-07-16WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLOld East Main Co.7855033e-6a12-4cd8-b0a2-c5d69018d1172026-07-16Warnings, Adverse reactionsExact identifier
application number: M012
Oxymetazoline Hydrochloride 12-HourOXYMETAZOLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.34a79f8b-32b7-48db-a895-c942cc7952922026-07-16WarningsExact identifier
application number: M012
LoHist DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.93c9ad4f-3376-48c2-8276-0375663acd012026-07-16WarningsExact identifier
application number: M012
SanatosMENTHOLPharmadel LLC522e1e7f-98ed-c475-e063-6294a90a622c2026-07-16WarningsExact identifier
application number: M012
LEADER MS Flu Relief NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCARDINAL HEALTH 110, LLC. DBA LEADER9db7d4e2-f7c1-41a7-8e1c-ef8d3512259d2026-07-16WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLC1bf4cd96-5800-434d-a0dc-e84c759ebb332026-07-16WarningsExact identifier
application number: M012
Mucus Relief Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENSINWalgreens2ace231a-94c4-479d-bb26-454bd07b207b2026-07-16WarningsExact identifier
application number: M012
LEADER No DripALLERGY SINUS NASAL MISTCARDINAL HEALTH 110, LLC. DBA LEADERe7b2c1c1-6250-4af3-b131-22aced2b23d52026-07-16WarningsExact identifier
application number: M012
Mucus Relief DM CoughDEXTROMETHORPHAN HBR, GUAIFENESINAmerisource Bergen639a59b7-ccff-485e-a232-38b6808272292026-07-16WarningsExact identifier
application number: M012
Equate Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.30470a01-4d42-44c6-a017-d68bb74cdef72026-07-15WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief - PlusASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association1f93fe6d-ee21-e323-e063-6394a90a61bf2026-07-15WarningsExact identifier
application number: M012
Pentrexcilina DaytimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb7b3c15a-bb28-5c25-e053-2a95a90ad3b12026-07-15WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association1f93c815-63c7-bfe0-e063-6394a90ab4a52026-07-15WarningsExact identifier
application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp5fa848ef-35ee-4e05-8ff2-781d034cf6ac2026-07-14WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCardinal Health 110, LLC. DBA Leader0fad61d8-4393-47ec-9ff6-7df5be761f5b2026-07-14WarningsExact identifier
application number: M012
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLRite Aid Corporation211c4273-3b2c-4169-b9c6-7a87903e77cd2026-07-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN5187c0c9-83a3-452e-aceb-95f24fc20e925
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD5187c0c9-83a3-452e-aceb-95f24fc20e925
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY5187c0c9-83a3-452e-aceb-95f24fc20e925
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY5187c0c9-83a3-452e-aceb-95f24fc20e925
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY5187c0c9-83a3-452e-aceb-95f24fc20e925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-869-04638680869041 BOTTLE, PLASTIC in 1 BOX (63868-869-04) / 118 mL in 1 BOTTLE, PLASTIC2018-08-312026-12-28NoNoCurrent