FDA.reportPublic FDA data

Adult Tussin DM

Product NDC
66715-6858
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
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
Adult Tussin DM
Brand name suffix
Lil Drug Store Products
Listing expiration
2027-12-31

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 32 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCa401eb92-60b6-427d-a677-29371a3150be2026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC3ff4c4ea-7628-4d2b-a6e9-d994c25baef42026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd7c18e95-8d7b-4550-9a20-fc704a114adb2026-05-12WarningsExact identifier
application number: M012
Mucinex Childrens Cough and Chest Congestion Mini-Melts Orange CremeDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC66543190-1d3d-4259-ae73-d366ecbf9e522026-05-12WarningsExact identifier
application number: M012
basic care daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC612719a9-fa2e-4c40-8f35-a399aeaafecc2026-05-12WarningsExact identifier
application number: M012
Sinus Pressure and Pain Daytime Nighttime Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company3cac44ad-1835-487e-b6d0-1483d724bb5e2026-05-12WarningsExact identifier
application number: M012
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANCardinal Health 107, LLC9cfb1abb-98c4-4e90-8dd7-fcffc112f9882026-05-12WarningsExact identifier
application number: M012
Nasal Decongestant PE and Pain Relief Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLWinCo Foods, LLCfab51b36-1c2e-4c97-932c-dacfaf55935a2026-05-11WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINWalgreen Companycad5da8c-65a6-44c4-a4c7-38f2c7fe43aa2026-05-11WarningsExact identifier
application number: M012
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
application number: M012
Device - NebuClear MD Hand-held Rubber Bulb NebulizerDEVICE - HAND-HELD RUBBER BULB NEBULIZERBlue Echo Care LLC43e0a646-be57-1024-e063-6394a90a43e42026-05-11WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED1efd1778-7ab1-4797-98c5-4637940ee3ec2026-05-11WarningsExact identifier
application number: M012
DayTime High Blood Pressure Cold and Flu Relief Liquid filled SoftgelsACETAMINOPHEN,DEXTROMETHROPHAN HBRAptaPharma Inc.0380035e-44d5-44ea-9d1c-d57a1de651882026-05-10WarningsExact identifier
application number: M012
Night Time Cold and Flu relief liquid filled softgelsACETAMINOPHEN,DEXTROMETHROPHAN HBR,DOXYLAMINE SUCCINATEAptaPharma Inc.d61e2186-8b59-45f9-96ec-83430a0fe0cb2026-05-10WarningsExact identifier
application number: M012
Maximum Strength Tussin DM Liquid filled SoftgelsDEXTROMETHORPHAN HBR, GUAIFENESINAptaPharma Inc.39ad6cc9-d2b0-4b4a-8aa3-977905c9e6f12026-05-10WarningsExact identifier
application number: M012
Day-Time Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c2026-05-10WarningsExact identifier
application number: M012
Daytime Cold and Flu Relief Liquid Filled SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.c078efb5-d30e-4dd1-a600-6e827390df762026-05-10WarningsExact identifier
application number: M012
DM Max CONGESTION and COUGHDEXTROMETHORPHAN HBR, GUAIFENESINDeMoulas Market Basketb12e26b2-79e4-45a5-9a90-4630f92457d02026-05-09WarningsExact identifier
application number: M012
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Companyfac55d76-457f-4258-9cc8-6edae539cada2026-05-08WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyVee Inc5a0ef8ae-f6d5-4388-b4da-6b7f025160b22026-05-08WarningsExact 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