Adult Cough and Chest Congestion Relief DM

Product NDC
21130-385
11-digit product format
211300385
Labeler code
21130
Product ID
21130-385_2409db7e-fb17-4b06-b55a-3f3036dd0f54
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Safeway, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-30
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Adult Cough and Chest Congestion Relief DM
Brand name suffix
Non Drowsy
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui996520

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
21130-385-04Adult Cough and Chest Congestion Relief DMNon Drowsy118 mL in 1 BOTTLE, PLASTICLIQUID11813
21130-385-04Adult Cough and Chest Congestion Relief DMNon Drowsy1 in 1 BOXLIQUID113
21130-385-08Adult Cough and Chest Congestion Relief DMNon Drowsy237 mL in 1 BOTTLE, PLASTICLIQUID23713
21130-385-08Adult Cough and Chest Congestion Relief DMNon Drowsy1 in 1 BOXLIQUID113

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]3
GUAIFENESINACTIVE INGREDIENT495W7451VQADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]3
GUAIFENESINACTIVE MOIETY495W7451VQADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]3
GLUCOSE OXIDASEINACTIVE INGREDIENT0T8392U5N1ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]3
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3AADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-385ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]11Current NDC, Legacy NDC, 4 package rows20241105_5bd508a0-2f75-413e-a690-bed970131bef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN5bd508a0-2f75-413e-a690-bed970131bef13
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD5bd508a0-2f75-413e-a690-bed970131bef13
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY5bd508a0-2f75-413e-a690-bed970131bef13
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY5bd508a0-2f75-413e-a690-bed970131bef13
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY5bd508a0-2f75-413e-a690-bed970131bef13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-385-04211300385041 BOTTLE, PLASTIC in 1 BOX (21130-385-04) / 118 mL in 1 BOTTLE, PLASTIC2014-06-300000-00-00NoNoCurrent
21130-385-08211300385081 BOTTLE, PLASTIC in 1 BOX (21130-385-08) / 237 mL in 1 BOTTLE, PLASTIC2014-06-300000-00-00NoNoCurrent