FDA.reportPublic FDA data

Supress DM

Product NDC
52083-058
11-digit product format
520830058
Labeler code
52083
Product ID
52083-058_974dbf24-7689-4e94-a535-d5b59c097406
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
SYRUP
Route
ORAL
Labeler
KRAMER NOVIS
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-10-02
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
5; 50 mg/mL; mg/mL
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
Supress DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/mL
GUAIFENESIN50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1439992

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-058-012025-11-18C16284748780-12cef2736-5f9c-d83d-e063-dadaa90ab31fSupress DM
52083-058-012025-01-30C16284748780-12cef2736-5f9c-d83d-e063-dadaa90ab31fSupress DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-058-01Supress DM30 mL in 1 BOTTLESYRUP305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-058-01ML - Milliliter52083-0589db1418f-5f10-40ad-9fa8-1f0b9c5e8a8512013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]1
GUAIFENESINACTIVE INGREDIENT495W7451VQSUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]1
GUAIFENESINACTIVE MOIETY495W7451VQSUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]1
WATERINACTIVE INGREDIENT059QF0KO0RSUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-058SUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]4Current NDC, Legacy NDC, 1 package rows20181213_7da0611e-729c-4cf8-88f3-f8877b9f5cfa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1439992dextromethorphan HBr 5 MG / guaiFENesin 50 MG in 1 mL Oral SolutionPSN7da0611e-729c-4cf8-88f3-f8877b9f5cfa5
1439992dextromethorphan hydrobromide 5 MG/ML / guaifenesin 50 MG/ML Oral SolutionSCD7da0611e-729c-4cf8-88f3-f8877b9f5cfa5
1439992dextromethorphan hydrobromide 5 MG/ML / GG 50 MG/ML Oral SolutionSY7da0611e-729c-4cf8-88f3-f8877b9f5cfa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-058-015208300580130 mL in 1 BOTTLE (52083-058-01) 30 ml2013-10-020000-00-00NoNoCurrent