FDA.reportPublic FDA data

Delsym

Product NDC
63824-171
11-digit product format
638240171
Labeler code
63824
Product ID
63824-171_5245879b-488e-4a7e-e063-6294a90a9dd2
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
NDA018658
Marketing category
NDA
Marketing start
2010-05-04
Substance
DEXTROMETHORPHAN
Active strength
30 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
Delsym
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7355X3ROTS
Rxcui1373045, 1373128

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-171-222022-06-21C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-222022-06-21C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-632022-06-21C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-632022-06-21C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-652022-06-21C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-652022-06-21C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-752022-06-21C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-752022-06-21C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-222022-01-28C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-222022-01-28C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-632022-01-28C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-632022-01-28C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-652022-01-28C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-652022-01-28C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-752022-01-28C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape
63824-171-752022-01-28C16284748780-1d6a99b39-852e-a426-e053-dadaa90af4c2Delsym 12 Hour Cough Relief Grape

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-171-22Delsym1 in 1 CARTONSUSPENSION, EXTENDED RELEASE114
63824-171-22Delsym2 in 1 CELLO PACKSUSPENSION, EXTENDED RELEASE214
63824-171-63Delsym89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE8914
63824-171-63Delsym1 in 1 CARTONSUSPENSION, EXTENDED RELEASE114
63824-171-65Delsym1 in 1 CARTONSUSPENSION, EXTENDED RELEASE114
63824-171-65Delsym148 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE14814
63824-171-75Delsym15 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE1514
63824-171-75Delsym1 in 1 CARTONSUSPENSION, EXTENDED RELEASE114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-171-63ML - Milliliter63824-1711bddda2c-79bb-42f5-b372-f91183329d6d12012-07-24
63824-171-65ML - Milliliter63824-171abd6b6f5-948c-4c45-a390-9bae52a45eda12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DextromethorphanACTIVE INGREDIENT7355X3ROTSDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
DextromethorphanACTIVE MOIETY7355X3ROTSDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
D&C Red NO. 33INACTIVE INGREDIENT9DBA0SBB0LDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
edetate disodiumINACTIVE INGREDIENT7FLD91C86KDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
FD&C Blue NO. 1INACTIVE INGREDIENTH3R47K3TBDDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
high fructose corn syrupINACTIVE INGREDIENTXY6UN3QB6SDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
methylparabenINACTIVE INGREDIENTA2I8C7HI9TDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
PolistirexINACTIVE INGREDIENT5H9W9GTW27DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
sucroseINACTIVE INGREDIENTC151H8M554DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
tragacanthINACTIVE INGREDIENT2944357O2ODELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
waterINACTIVE INGREDIENT059QF0KO0RDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
xanthan gumINACTIVE INGREDIENTTTV12P4NEEDELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
DEXTROMETHORPHANACTIVE INGREDIENT7355X3ROTSDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
CORN OILINACTIVE INGREDIENT8470G57WFMDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554DELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
TRAGACANTHINACTIVE INGREDIENT2944357O2ODELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-171DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RB HEALTH (US) LLC]12Current NDC, Legacy NDC, 8 package rows20220623_234e6a2c-a280-4a39-8777-9316e9d681fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373128Delsym 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN234e6a2c-a280-4a39-8777-9316e9d681fb14
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN234e6a2c-a280-4a39-8777-9316e9d681fb14
137312812 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym]SBD234e6a2c-a280-4a39-8777-9316e9d681fb14
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD234e6a2c-a280-4a39-8777-9316e9d681fb14
1373128Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release SuspensionSY234e6a2c-a280-4a39-8777-9316e9d681fb14
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY234e6a2c-a280-4a39-8777-9316e9d681fb14
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY234e6a2c-a280-4a39-8777-9316e9d681fb14
1373128Delsym 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN00f8f5b4-f5a8-4dcf-8133-15964ad4801e5
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN00f8f5b4-f5a8-4dcf-8133-15964ad4801e5
137312812 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym]SBD00f8f5b4-f5a8-4dcf-8133-15964ad4801e5
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD00f8f5b4-f5a8-4dcf-8133-15964ad4801e5
1373128Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release SuspensionSY00f8f5b4-f5a8-4dcf-8133-15964ad4801e5
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY00f8f5b4-f5a8-4dcf-8133-15964ad4801e5
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY00f8f5b4-f5a8-4dcf-8133-15964ad4801e5
1373128Delsym 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN4abb0813-e080-4bae-b829-e2c29d0a8d4f1
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN4abb0813-e080-4bae-b829-e2c29d0a8d4f1
137312812 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym]SBD4abb0813-e080-4bae-b829-e2c29d0a8d4f1
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD4abb0813-e080-4bae-b829-e2c29d0a8d4f1
1373128Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release SuspensionSY4abb0813-e080-4bae-b829-e2c29d0a8d4f1
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY4abb0813-e080-4bae-b829-e2c29d0a8d4f1
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY4abb0813-e080-4bae-b829-e2c29d0a8d4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-171-22638240171222 CARTON in 1 CELLO PACK (63824-171-22) / 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE2 carton2010-05-040000-00-00NoNoCurrent
63824-171-63638240171631 BOTTLE in 1 CARTON (63824-171-63) / 89 mL in 1 BOTTLE1 bottle2010-05-040000-00-00NoNoCurrent
63824-171-65638240171651 BOTTLE in 1 CARTON (63824-171-65) / 148 mL in 1 BOTTLE1 bottle2010-05-040000-00-00NoNoCurrent
63824-171-75638240171751 BOTTLE in 1 CARTON (63824-171-75) / 15 mL in 1 BOTTLE1 bottle2010-05-040000-00-00NoNoCurrent