Delsym

Product NDC
21695-518
11-digit product format
216950518
Labeler code
21695
Product ID
21695-518_4abb0813-e080-4bae-b829-e2c29d0a8d4f
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Polistirex
Dosage form
SYRUP
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA018658
Marketing category
NDA
Marketing start
2009-09-04
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN
Active strength
30 mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-518IInactivated by FDA2026-08-11
excluded packagepackage21695-51821695-518-30IInactivated by FDA2026-08-11

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-518-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-518-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-518-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-518-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-518-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-518-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-518-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-518-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-518-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-518-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-518-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-518-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-518-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-518-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-518-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-518-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-518-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-518-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-518-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-518-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-518-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-518-30110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018658-001DELSYMEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORALRLD, RS1982-10-08cb3db0bc1861…

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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
21695-518-302019-09-24C16284748780-1934fe258-4899-48b1-e053-8cdaa90a720aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-518-30Delsym90 mL in 1 BOTTLESYRUP901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
21695-518DELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_4abb0813-e080-4bae-b829-e2c29d0a8d4f.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
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 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 formatDescriptionUnitsStatus
21695-518-302169505183090 mL in 1 BOTTLE90 mlHistorical