FDA.reportPublic FDA data

Creomulsion

Product NDC
70893-0012
11-digit product format
708930012
Labeler code
70893
Product ID
70893-0012_4b0cac24-9068-3fda-e063-6394a90abd45
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
SYRUP
Route
ORAL
Labeler
Socius Care, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-11
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
5 mg/5mL
Pharmacologic classes
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

Additional Listing Data#

Finished product
Yes
Brand name base
Creomulsion
Brand name suffix
For Children
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1090946, 1246254

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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70893-0012-0CreomulsionFor Children1 in 1 CARTONSYRUP110
70893-0012-1CreomulsionFor Children118 mL in 1 BOTTLESYRUP11810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70893-0012CREOMULSION FOR CHILDREN (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SOCIUS CARE, LLC]8Current NDC, Legacy NDC, 2 package rows20250110_39d0e96c-1cc3-4961-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246254Creomulsion 5 MG in 5 mL Oral SolutionPSN39d0e96c-1cc3-4961-e054-00144ff88e8810
1090946dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSN39d0e96c-1cc3-4961-e054-00144ff88e8810
1246254dextromethorphan hydrobromide 1 MG/ML Oral Solution [Creomulsion]SBD39d0e96c-1cc3-4961-e054-00144ff88e8810
1090946dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD39d0e96c-1cc3-4961-e054-00144ff88e8810
1246254Creomulsion 1 MG/ML Oral SolutionSY39d0e96c-1cc3-4961-e054-00144ff88e8810
1246254Creomulsion 5 MG per 5 ML Oral SolutionSY39d0e96c-1cc3-4961-e054-00144ff88e8810
1090946dextromethorphan HBr 20 MG in 20 mL Oral SolutionSY39d0e96c-1cc3-4961-e054-00144ff88e8810
1090946dextromethorphan hydrobromide 5 MG per 5 ML Oral SolutionSY39d0e96c-1cc3-4961-e054-00144ff88e8810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70893-0012-0708930012001 BOTTLE in 1 CARTON (70893-0012-0) / 118 mL in 1 BOTTLE (70893-0012-1) 1 bottle2016-08-110000-00-00NoNoCurrent
70893-0012-170893001201118 mL in 1 BOTTLE118 mlHistorical