FDA.reportPublic FDA data

Creomulsion

Product NDC
70893-0011
11-digit product format
708930011
Labeler code
70893
Product ID
70893-0011_4b0cae9f-cd7d-3372-e063-6294a90ad356
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
20 mg/15mL
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

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
Creomulsion
Brand name suffix
Cough Medicine Adult Formula
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1246338Internal RxNorm lookup
1246340Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
39d07486-99b7-5c06-e054-00144ff8d46cAvailable 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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70893-0011-0CreomulsionCough Medicine Adult Formula1 in 1 CARTONSYRUP19
70893-0011-1CreomulsionCough Medicine Adult Formula118 mL in 1 BOTTLESYRUP1189

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70893-0011CREOMULSION COUGH MEDICINE ADULT FORMULA (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SOCIUS CARE, LLC]7Current NDC, Legacy NDC, 2 package rows20250110_39d07486-99b7-5c06-e054-00144ff8d46c.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 17 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporationf1a4ee57-33a3-4791-a769-b208b38acb722026-07-13WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY Childrens Allergy ReliefDIPHENHYDRAMINE HCLAMERISOURCE BERGENc499574c-f32b-4608-bf8b-51ad44e357252026-07-13WarningsExact identifier
application number: M012
Good NeighborChildrens Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLAMERISOURCE BERGENf442c61b-7d2c-401c-b862-acbe2282927b2026-07-13WarningsExact identifier
application number: M012
SanatosMENTHOLPharmadel LLC5683b099-f029-2d08-e063-6394a90ad4822026-07-13WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f673cdeb-4f8b-46b4-be92-c725d74abc552026-07-13WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEe4fca5ba-2d45-4c38-b0fd-297159d1705a2026-07-13WarningsExact identifier
application number: M012
Good Neighbor Sugar Free Adult Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINAMERISOURCE BERGEN0269c0fd-0d8f-4264-9025-d4dcb3c45c602026-07-13WarningsExact identifier
application number: M012
Propolis Cooling Relief Cherry Cough DropsMENTHOL, UNSPECIFIED FORMBeekeeper's Naturals USA Inc7087566d-f24a-4508-aa25-7f42d055c43e2026-07-13WarningsExact identifier
application number: M012
Sinus Pressure and Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLRite Aid Corporation35bcf263-3296-4d9c-84c0-146a173d6e872026-07-13WarningsExact identifier
application number: M012
Good Neighbor Childrens Cough Relief Cherry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINAMERISOURCE BERGENa8e2fd43-b801-41ae-8d79-8ecf4a7715432026-07-13WarningsExact identifier
application number: M012
Good Neighbor No Drip Nasal Mist Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEAMERISOURCE BERGEN7872aadd-b23c-431f-8048-24eece25ca2d2026-07-13WarningsExact identifier
application number: M012
Good Neighbor Dye Free Adult Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINAMERISOURCE BERGEN404a3521-8340-4476-a068-0e69cd0e514f2026-07-13WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab52026-07-13WarningsExact identifier
application number: M012
Good Neighbor Long Acting Cough Adult TussinDEXTROMETHORPHAN HBRAMERISOURCE BERGENdf3c76bd-bd5b-42d7-a5f1-560fd3cba6462026-07-13WarningsExact identifier
application number: M012
Good Neighbor Adult Tussin Mucus and chest congestionGUAIFENESINAMERISOURCE BERGEN97e9cd18-dd55-4a26-80e3-4c17b9e1a1e82026-07-13WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEAMERISOURCE BERGENa217ca8a-1c00-4816-bc26-cc0f71c80c902026-07-13WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company1ddc04fb-069c-44fe-814b-ba4f503c4be02026-07-10WarningsExact identifier
application number: M012
COUGH DROPS- menthol granuleMENTHOL GRANULEAnhui Jiuhe Health Industry Co., Ltd5351b943-5830-e4e7-e063-6394a90a5b662026-07-10WarningsExact identifier
application number: M012
ValuMeds Nasal Decongestant PE PhenylephrinePHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.3f284420-87c1-4c17-99e5-bc569bf9d45f2026-07-10WarningsExact identifier
application number: M012
Severe Congestion and Cough Multi-Symptom Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy707eb066-cdfc-444b-833a-9d6d133d48e42026-07-10WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246340Creomulsion 20 MG in 15 mL Oral SolutionPSN39d07486-99b7-5c06-e054-00144ff8d46c9
1246338dextromethorphan HBr 20 MG in 15 mL Oral SolutionPSN39d07486-99b7-5c06-e054-00144ff8d46c9
1246340dextromethorphan hydrobromide 1.33 MG/ML Oral Solution [Creomulsion]SBD39d07486-99b7-5c06-e054-00144ff8d46c9
1246338dextromethorphan hydrobromide 1.33 MG/ML Oral SolutionSCD39d07486-99b7-5c06-e054-00144ff8d46c9
1246340Creomulsion 1.33 MG/ML Oral SolutionSY39d07486-99b7-5c06-e054-00144ff8d46c9
1246340Creomulsion 20 MG per 15 ML SyrupSY39d07486-99b7-5c06-e054-00144ff8d46c9
1246338dextromethorphan hydrobromide 20 MG per 15 ML Oral SolutionSY39d07486-99b7-5c06-e054-00144ff8d46c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70893-0011-0708930011001 BOTTLE in 1 CARTON (70893-0011-0) / 118 mL in 1 BOTTLE (70893-0011-1) 1 bottle2016-08-110000-00-00NoNoCurrent
70893-0011-170893001101118 mL in 1 BOTTLE118 mlHistorical