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 26 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWALMART INC.321430a5-11c9-4d33-8638-5149f601f1bb2026-05-22WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLDolgencorp Incddcc1e78-4ea8-4489-88e7-86ff460164642026-05-21WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY DAYTIME FLU RELIEF MAX STRENGTHACETAMINOPHEN, DEXTROMETHORPHAN HBRAMERISOURCE BERGEN45dc9dd7-134a-4e70-a07e-7bfdf0dc1c4e2026-05-21WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEKenvue Brands LLC525467fb-510d-0b4b-e063-6294a90acd362026-05-21WarningsExact identifier
application number: M012
Mucinex ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLReckitt Benckiser LLC4cee80e5-e412-e832-e063-6394a90aeb902026-05-21WarningsExact identifier
application number: M012
Mucinex Childrens Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRReckitt Benckiser LLC4a9464cf-0c77-23d0-e063-6394a90a62f12026-05-21WarningsExact identifier
application number: M012
Mucinex Childrens Night Time Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLReckitt Benckiser LLC4ceda68e-c7ce-eb87-e063-6394a90a8ded2026-05-21WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.5258ea3f-87f1-7f86-e063-6394a90ab82f2026-05-21WarningsExact identifier
application number: M012
RELIABLE-1 ANTI DRIP PUMP MISTOXYMETAZOLINE HYDROCHLORIDEReliable 1 Laboratories LLC7df9905d-09aa-4c84-8b6f-6e5ed90df0da2026-05-21WarningsExact identifier
application number: M012
daytime nitetimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Inc80abb6b8-b0d5-4f19-8588-50b8717510bb2026-05-21WarningsExact identifier
application number: M012
FAMILY DOLLAR ULTRA FINE MIST SINUS RELIEFOXYMETAZOLINE HYDROCHLORIDEFAMILY DOLLAR SERVICES INC27163169-54d0-4b6e-94cd-721b29b182492026-05-20WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Cough FastACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5241b11a-72c8-5e67-e063-6394a90a43532026-05-20WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC50b140ad-aba2-ce6b-e063-6294a90ae2f82026-05-20WarningsExact identifier
application number: M012
Mucinex Fast-Max Recharge Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC4bae240c-70ce-e9c2-e063-6394a90a5f3d2026-05-20WarningsExact identifier
application number: M012
Childrens Mucinex Multi Symptom Cold and Childrens Mucinex Night Time Multi Symptom ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC85f7d60b-32ec-4ec2-86ec-f677093bce1d2026-05-20WarningsExact identifier
application number: M012
Chloraseptic Nighttime Sore Throat Hot ReliefACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEPrestige Brands Holdings, Inc.9c13c052-a5d1-43d2-8d29-4ea011a971ac2026-05-20WarningsExact identifier
application number: M012
Cold and Flu Severe, Daytime, NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporationa0bff310-2d35-4a18-815b-8386e44730a22026-05-19WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.61a1beb3-decf-4c8d-a402-93a02ec40a432026-05-19WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC52291746-2bbf-8f3f-e063-6294a90adcfc2026-05-19WarningsExact identifier
application number: M012
MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift KickstartACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, TRIPROLIDINE HCIReckitt Benckiser LLCfdb70793-5dd1-0455-e053-6394a90ac6212026-05-19WarningsExact 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