Delsym (Dextromethorphan)

Product NDC
63824-173
11-digit product format
638240173
Labeler code
63824
Product ID
63824-173_5245a16e-bae3-b3d4-e063-6294a90ace45
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
2011-08-19
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63824-173-6586f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63824-173-6386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63824-173-65bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63824-173-63bd6a592717d7…303034d00443…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63824-173-639bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63824-173-659bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018658-001DELSYMDEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-083f01610625f2…
2019-09-15 20:21 UTC2019-09N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Delsym (Dextromethorphan)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN30 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7355X3ROTSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1373045Internal RxNorm lookup
1373128Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb0116d0-93e4-44e2-b0e4-c0b773eced6fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-173-63Delsym (Dextromethorphan)89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE895
63824-173-63Delsym (Dextromethorphan)1 in 1 CARTONSUSPENSION, EXTENDED RELEASE15
63824-173-65Delsym (Dextromethorphan)148 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE1485
63824-173-65Delsym (Dextromethorphan)1 in 1 CARTONSUSPENSION, EXTENDED RELEASE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-173-63ML - Milliliter63824-17338c32416-7e7f-4110-8732-f36a5cc28e9512015-10-02
63824-173-65ML - Milliliter63824-17327022dd2-7b65-45d3-a131-97a2f71e866b12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHANACTIVE INGREDIENT7355X3ROTSDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
POLISTIREXINACTIVE INGREDIENT5H9W9GTW27DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
TRAGACANTHINACTIVE INGREDIENT2944357O2ODELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-173DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RB HEALTH (US) LLC]4Current NDC, Legacy NDC, 4 package rows20220623_bb0116d0-93e4-44e2-b0e4-c0b773eced6f.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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DelsymDEXTROMETHORPHANReckitt Benckiser LLC234e6a2c-a280-4a39-8777-9316e9d681fb2026-05-27WarningsExact identifier
application applno (NDA): 018658
application number: NDA018658
DelsymDEXTROMETHORPHANReckitt Benckiser LLCe3e1d126-76c2-4776-8ce0-449625b7e6ba2026-05-27WarningsExact identifier
application applno (NDA): 018658
application number: NDA018658
Delsym (Dextromethorphan)DEXTROMETHORPHANReckitt Benckiser LLCbb0116d0-93e4-44e2-b0e4-c0b773eced6f2026-05-20WarningsExact identifier
application applno (NDA): 018658
application number: NDA018658
ndc (product): 63824-173
Delsym (Dextromethorphan)DEXTROMETHORPHANReckitt Benckiser LLCce4b477c-430e-40a3-b247-b3914ef177932026-05-13WarningsExact identifier
application applno (NDA): 018658
application number: NDA018658
DELSYMDEXTROMETHORPHANA-S Medication Solutions2ac3cac7-5980-4ff5-9939-d494c3daa9d22025-02-28WarningsExact identifier
application applno (NDA): 018658
application number: NDA018658

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373128Delsym 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSNbb0116d0-93e4-44e2-b0e4-c0b773eced6f5
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSNbb0116d0-93e4-44e2-b0e4-c0b773eced6f5
137312812 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym]SBDbb0116d0-93e4-44e2-b0e4-c0b773eced6f5
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCDbb0116d0-93e4-44e2-b0e4-c0b773eced6f5
1373128Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release SuspensionSYbb0116d0-93e4-44e2-b0e4-c0b773eced6f5
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSYbb0116d0-93e4-44e2-b0e4-c0b773eced6f5
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSYbb0116d0-93e4-44e2-b0e4-c0b773eced6f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-173-63638240173631 BOTTLE in 1 CARTON (63824-173-63) / 89 mL in 1 BOTTLE1 bottle2011-08-190000-00-00NoNoCurrent
63824-173-65638240173651 BOTTLE in 1 CARTON (63824-173-65) / 148 mL in 1 BOTTLE1 bottle2011-08-190000-00-00NoNoCurrent