FDA.reportPublic FDA data

PECGEN DMX

Product NDC
52083-630
11-digit product format
520830630
Labeler code
52083
Product ID
52083-630_73a7e53a-91e6-4f2a-98f0-d73ba7995194
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
KRAMER NOVIS
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-04-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 187 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

Additional Listing Data#

Finished product
Yes
Brand name base
PECGEN DMX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN187 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1441364

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-630-162025-11-18C16284748780-12cef2736-8a63-d83d-e063-dadaa90ab31fPECGEN ® DMX
52083-630-162025-01-30C16284748780-12cef2736-8a63-d83d-e063-dadaa90ab31fPECGEN ® DMX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-630-16PECGEN DMX474 mL in 1 BOTTLE, PLASTICSOLUTION4745

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-630-16ML - Milliliter52083-630d3358e56-bf8e-4654-bb6b-e3acb1fbb97712015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHPECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]2
GUAIFENESINACTIVE INGREDIENT495W7451VQPECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSPECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]2
GUAIFENESINACTIVE MOIETY495W7451VQPECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]2
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3APECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]2
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-630PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KRAMER NOVIS]4Current NDC, Legacy NDC, 1 package rows20190920_a627824c-5e3d-4672-a047-6c801b50b432.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1441364dextromethorphan HBr 10 MG / guaiFENesin 187 MG in 5 mL Oral SolutionPSNa627824c-5e3d-4672-a047-6c801b50b4325
1441364dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral SolutionSCDa627824c-5e3d-4672-a047-6c801b50b4325
1441364dextromethorphan hydrobromide 10 MG / guaifenesin 187 MG per 5 ML Oral SolutionSYa627824c-5e3d-4672-a047-6c801b50b4325

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-630-1652083063016474 mL in 1 BOTTLE, PLASTIC (52083-630-16) 474 ml2015-04-010000-00-00NoNoCurrent