DELSYM
- Product NDC
- 50090-0224
- 11-digit product format
- 500900224
- Labeler code
- 50090
- Product ID
- 50090-0224_018b0d50-2f6c-447a-a3bc-f43f639834b1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan
- Dosage form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018658-001 | DELSYM | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018658-001 | DELSYM | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 1982-10-08 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DELSYM
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN | 30 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7355X3ROTS | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2ac3cac7-5980-4ff5-9939-d494c3daa9d2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-0224-0 | DELSYM | 89 mL in 1 BOTTLE | SUSPENSION, EXTENDED RELEASE | 89 | 19 | |
| 50090-0224-0 | DELSYM | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-0224-0 | ML - Milliliter | 50090-0224 | 3c7a605b-048c-4053-87e1-e34dda64bec6 | 1 | 2018-08-13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-0224 | DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 19 | Current NDC, Legacy NDC, 2 package rows | 20250302_2ac3cac7-5980-4ff5-9939-d494c3daa9d2.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Delsym | DEXTROMETHORPHAN | Reckitt Benckiser LLC | 234e6a2c-a280-4a39-8777-9316e9d681fb | 2026-05-27 | Warnings | 018658 NDA018658 |
| Delsym | DEXTROMETHORPHAN | Reckitt Benckiser LLC | e3e1d126-76c2-4776-8ce0-449625b7e6ba | 2026-05-27 | Warnings | 018658 NDA018658 |
| Delsym (Dextromethorphan) | DEXTROMETHORPHAN | Reckitt Benckiser LLC | bb0116d0-93e4-44e2-b0e4-c0b773eced6f | 2026-05-20 | Warnings | 018658 NDA018658 |
| Delsym (Dextromethorphan) | DEXTROMETHORPHAN | Reckitt Benckiser LLC | ce4b477c-430e-40a3-b247-b3914ef17793 | 2026-05-13 | Warnings | 018658 NDA018658 |
| DELSYM | DEXTROMETHORPHAN | A-S Medication Solutions | 2ac3cac7-5980-4ff5-9939-d494c3daa9d2 | 2025-02-28 | Warnings | 018658 NDA018658 50090-0224 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1373128 | Delsym 30 MG in 5 mL 12HR Extended Release Oral Suspension | PSN | 2ac3cac7-5980-4ff5-9939-d494c3daa9d2 | 19 |
| 1373045 | dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension | PSN | 2ac3cac7-5980-4ff5-9939-d494c3daa9d2 | 19 |
| 1373128 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym] | SBD | 2ac3cac7-5980-4ff5-9939-d494c3daa9d2 | 19 |
| 1373045 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension | SCD | 2ac3cac7-5980-4ff5-9939-d494c3daa9d2 | 19 |
| 1373128 | Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release Suspension | SY | 2ac3cac7-5980-4ff5-9939-d494c3daa9d2 | 19 |
| 1373045 | dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension | SY | 2ac3cac7-5980-4ff5-9939-d494c3daa9d2 | 19 |
| 1373045 | dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension | SY | 2ac3cac7-5980-4ff5-9939-d494c3daa9d2 | 19 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-0224-0 | 50090022400 | 1 BOTTLE in 1 CARTON (50090-0224-0) / 89 mL in 1 BOTTLE | 1 bottle | 2014-11-28 | 0000-00-00 | No | No | Current |