Delsym
- Product NDC
- 63824-175
- 11-digit product format
- 638240175
- Labeler code
- 63824
- Product ID
- 63824-175_52458749-2830-9058-e063-6394a90aadb9
- 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
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Delsym
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN | 30 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 7355X3ROTS |
| Rxcui | 1373045, 1373128 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-175-22 | Delsym | 2 in 1 CELLO PACK | SUSPENSION, EXTENDED RELEASE | 2 | 14 | |
| 63824-175-22 | Delsym | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | 14 | |
| 63824-175-63 | Delsym | 89 mL in 1 BOTTLE | SUSPENSION, EXTENDED RELEASE | 89 | 14 | |
| 63824-175-63 | Delsym | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | 14 | |
| 63824-175-65 | Delsym | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | 14 | |
| 63824-175-65 | Delsym | 148 mL in 1 BOTTLE | SUSPENSION, EXTENDED RELEASE | 148 | 14 | |
| 63824-175-75 | Delsym | 15 mL in 1 BOTTLE | SUSPENSION, EXTENDED RELEASE | 15 | 14 | |
| 63824-175-75 | Delsym | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-175-63 | ML - Milliliter | 63824-175 | e6829a5d-9e90-4855-8410-6e4d230aab4d | 1 | 2012-07-24 |
| 63824-175-65 | ML - Milliliter | 63824-175 | f6ae2467-895f-4f35-a2c0-4dcf5dcc494e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
| 1373128 | Delsym 30 MG in 5 mL 12HR Extended Release Oral Suspension | PSN | e3e1d126-76c2-4776-8ce0-449625b7e6ba | 14 |
| 1373045 | dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension | PSN | e3e1d126-76c2-4776-8ce0-449625b7e6ba | 14 |
| 1373128 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym] | SBD | e3e1d126-76c2-4776-8ce0-449625b7e6ba | 14 |
| 1373045 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension | SCD | e3e1d126-76c2-4776-8ce0-449625b7e6ba | 14 |
| 1373128 | Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release Suspension | SY | e3e1d126-76c2-4776-8ce0-449625b7e6ba | 14 |
| 1373045 | dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension | SY | e3e1d126-76c2-4776-8ce0-449625b7e6ba | 14 |
| 1373045 | dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension | SY | e3e1d126-76c2-4776-8ce0-449625b7e6ba | 14 |
| 1373128 | Delsym 30 MG in 5 mL 12HR Extended Release Oral Suspension | PSN | 671b249d-60f8-450d-8888-269552339b2f | 1 |
| 1373045 | dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension | PSN | 671b249d-60f8-450d-8888-269552339b2f | 1 |
| 1373128 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym] | SBD | 671b249d-60f8-450d-8888-269552339b2f | 1 |
| 1373045 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension | SCD | 671b249d-60f8-450d-8888-269552339b2f | 1 |
| 1373128 | Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release Suspension | SY | 671b249d-60f8-450d-8888-269552339b2f | 1 |
| 1373045 | dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension | SY | 671b249d-60f8-450d-8888-269552339b2f | 1 |
| 1373045 | dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension | SY | 671b249d-60f8-450d-8888-269552339b2f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-175-22 | 63824017522 | 2 CARTON in 1 CELLO PACK (63824-175-22) / 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE | 2 carton | 2010-05-04 | 0000-00-00 | No | No | Current |
| 63824-175-63 | 63824017563 | 1 BOTTLE in 1 CARTON (63824-175-63) / 89 mL in 1 BOTTLE | 1 bottle | 2010-05-04 | 0000-00-00 | No | No | Current |
| 63824-175-65 | 63824017565 | 1 BOTTLE in 1 CARTON (63824-175-65) / 148 mL in 1 BOTTLE | 1 bottle | 2010-05-04 | 0000-00-00 | No | No | Current |
| 63824-175-75 | 63824017575 | 1 BOTTLE in 1 CARTON (63824-175-75) / 15 mL in 1 BOTTLE | 1 bottle | 2010-05-04 | 0000-00-00 | No | No | Current |