FDA.reportPublic FDA data

Adult Tussin DM

Product NDC
66715-6858
Requested package NDC
66715-6858-4
11-digit product format
667156858
Labeler code
66715
Product ID
66715-6858_2a92670f-80b0-abdb-e063-6294a90a6342
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Lil' Drug Store Products, Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 100 mg/5mL; mg/5mL
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
2026-12-31
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
Adult Tussin DM
Brand name suffix
Lil Drug Store Products
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL

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
996520Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1915cf2a-ebaa-4c47-8991-5b741fa01be2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
66715-6858-4Adult Tussin DMLil Drug Store Products118 mL in 1 BOTTLE, PLASTICLIQUID1185
66715-6858-4Adult Tussin DMLil Drug Store Products1 in 1 CARTONLIQUID15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
GuaifenesinACTIVE INGREDIENT495W7451VQADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
DextromethorphanACTIVE MOIETY7355X3ROTSADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
GuaifenesinACTIVE MOIETY495W7451VQADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
DextroseINACTIVE INGREDIENTIY9XDZ35W2ADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
High Fructose Corn SyrupINACTIVE INGREDIENTXY6UN3QB6SADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Menthol, Unspecified FormINACTIVE INGREDIENTL7T10EIP3AADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Sodium benzoateINACTIVE INGREDIENTOJ245FE5EUADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
WaterINACTIVE INGREDIENT059QF0KO0RADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6858ADULT TUSSIN DM LIL DRUG STORE PRODUCTS (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [LIL' DRUG STORE PRODUCTS, INC]5Current NDC, Legacy NDC, 2 package rows20250101_1915cf2a-ebaa-4c47-8991-5b741fa01be2.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 1 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
application number: M012
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
application number: M012
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
application number: M012
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC3856c1e4-814f-85c4-e063-6394a90ab8a82026-09-09WarningsExact identifier
application number: M012
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
application number: M012
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
application number: M012
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
application number: M012
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyf4328b44-cdfa-41aa-e053-2995a90a27282026-09-08WarningsExact identifier
application number: M012
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact 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 SolutionPSN1915cf2a-ebaa-4c47-8991-5b741fa01be25
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1915cf2a-ebaa-4c47-8991-5b741fa01be25
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1915cf2a-ebaa-4c47-8991-5b741fa01be25
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY1915cf2a-ebaa-4c47-8991-5b741fa01be25
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY1915cf2a-ebaa-4c47-8991-5b741fa01be25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66715-6858-4667156858041 BOTTLE, PLASTIC in 1 CARTON (66715-6858-4) / 118 mL in 1 BOTTLE, PLASTIC2016-09-090000-00-00NoNoCurrent