Delsym (Dextromethorphan)

Product NDC
17856-0276
11-digit product format
178560276
Labeler code
17856
Product ID
17856-0276_bdd04e98-34da-44e9-b6e6-5e7eb3d23294
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
NDA018658
Marketing category
NDA
Marketing start
2011-08-19
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN
Active strength
30 mg/5mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct17856-0276IInactivated by FDA2026-08-17
excluded packagepackage17856-027617856-0276-1IInactivated by FDA2026-08-17

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0276-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0276-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0276-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0276-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-0276-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-0276-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0276-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0276-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0276-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-0276-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-0276-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-0276-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17856-0276-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-0276-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0276-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage17856-0276-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17856-0276-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17856-0276-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage17856-0276-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage17856-0276-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage17856-0276-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage17856-0276-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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…

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
17856-0276-12020-01-31C16284748780-19d75b9d0-fc79-f424-e053-dadaa90a57ceDelsym (Dextromethorphan) Suspension Extended-Release ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0276-1Delsym (Dextromethorphan)10 mL in 1 CUPSUSPENSION, EXTENDED RELEASE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0276DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 1 package rows20160505_56f5f9d1-54a6-48a5-8033-efc29e632479.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 SuspensionPSN56f5f9d1-54a6-48a5-8033-efc29e6324792
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN56f5f9d1-54a6-48a5-8033-efc29e6324792
137312812 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym]SBD56f5f9d1-54a6-48a5-8033-efc29e6324792
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD56f5f9d1-54a6-48a5-8033-efc29e6324792
1373128Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release SuspensionSY56f5f9d1-54a6-48a5-8033-efc29e6324792
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY56f5f9d1-54a6-48a5-8033-efc29e6324792
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY56f5f9d1-54a6-48a5-8033-efc29e6324792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0276-11785602760110 mL in 1 CUP10 mlHistorical