Delsym
- Product NDC
- 21695-517
- 11-digit product format
- 216950517
- Labeler code
- 21695
- Product ID
- 21695-517_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
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#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-517-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4899-48b1-e053-8cdaa90a720a | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-517-30 | Delsym | 90 mL in 1 BOTTLE | SYRUP | 90 | 1 |
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 | 4abb0813-e080-4bae-b829-e2c29d0a8d4f | 1 |
| 1373045 | dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension | PSN | 4abb0813-e080-4bae-b829-e2c29d0a8d4f | 1 |
| 1373128 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym] | SBD | 4abb0813-e080-4bae-b829-e2c29d0a8d4f | 1 |
| 1373045 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension | SCD | 4abb0813-e080-4bae-b829-e2c29d0a8d4f | 1 |
| 1373128 | Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release Suspension | SY | 4abb0813-e080-4bae-b829-e2c29d0a8d4f | 1 |
| 1373045 | dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension | SY | 4abb0813-e080-4bae-b829-e2c29d0a8d4f | 1 |
| 1373045 | dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension | SY | 4abb0813-e080-4bae-b829-e2c29d0a8d4f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-517-30 | 21695051730 | 90 mL in 1 BOTTLE | 90 ml | Historical |