Delsym

Product NDC
63824-160
11-digit product format
638240160
Labeler code
63824
Product ID
63824-160_350d558e-8f0c-48f5-aa84-21a52d7d7c1d
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-07-01
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL
Active strength
5 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct63824-160DDiscontinued by firm2026-10-05
excluded packagepackage63824-16063824-160-16DDiscontinued by firm2026-10-05

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 · 42 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63824-160-16DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63824-160-16DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63824-160-16DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63824-160-16DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63824-160-16DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63824-160-16DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63824-160-16DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63824-160-16DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63824-160-16DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63824-160-16DDiscontinued by firmad56d346431e…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 packagepackage63824-160-16IInactivated 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 packagepackage63824-160-16IInactivated 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 packagepackage63824-160-16IInactivated 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 packagepackage63824-160-16IInactivated 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 packagepackage63824-160-16IInactivated 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 packagepackage63824-160-16IInactivated 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 packagepackage63824-160-16IInactivated 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 packagepackage63824-160-16IInactivated 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 packagepackage63824-160-16IInactivated 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 packagepackage63824-160-16IInactivated 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 packagepackage63824-160-16IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-160-162024-10-08C16284748780-19d75b9cf-e7c2-f424-e053-dadaa90a57ceDelsym ® Cough Relief Plus Soothing Action
63824-160-162020-01-31C16284748780-19d75b9cf-e7c2-f424-e053-dadaa90a57ceDelsym ® Cough Relief Plus Soothing Action

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-160-16EA - Each63824-1609c95c524-6ed9-4eef-b236-e8770ed2dace12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHDELSYM COUGH RELIEF PLUS SOOTHING ACTION (DEXTROMETHORPHAN HYDROBROMIDE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
MentholACTIVE INGREDIENTL7T10EIP3ADELSYM COUGH RELIEF PLUS SOOTHING ACTION (DEXTROMETHORPHAN HYDROBROMIDE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
DextromethorphanACTIVE MOIETY7355X3ROTSDELSYM COUGH RELIEF PLUS SOOTHING ACTION (DEXTROMETHORPHAN HYDROBROMIDE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
MentholACTIVE MOIETYL7T10EIP3ADELSYM COUGH RELIEF PLUS SOOTHING ACTION (DEXTROMETHORPHAN HYDROBROMIDE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
D&C yellow No. 10INACTIVE INGREDIENT35SW5USQ3GDELSYM COUGH RELIEF PLUS SOOTHING ACTION (DEXTROMETHORPHAN HYDROBROMIDE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
FD&C yellow No. 6INACTIVE INGREDIENTH77VEI93A8DELSYM COUGH RELIEF PLUS SOOTHING ACTION (DEXTROMETHORPHAN HYDROBROMIDE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DELSYM COUGH RELIEF PLUS SOOTHING ACTION (DEXTROMETHORPHAN HYDROBROMIDE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4DELSYM COUGH RELIEF PLUS SOOTHING ACTION (DEXTROMETHORPHAN HYDROBROMIDE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
sucroseINACTIVE INGREDIENTC151H8M554DELSYM COUGH RELIEF PLUS SOOTHING ACTION (DEXTROMETHORPHAN HYDROBROMIDE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1
waterINACTIVE INGREDIENT059QF0KO0RDELSYM COUGH RELIEF PLUS SOOTHING ACTION (DEXTROMETHORPHAN HYDROBROMIDE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]1