Delsym
- Product NDC
- 63824-172
- 11-digit product format
- 638240172
- Labeler code
- 63824
- Product ID
- 63824-172_123cad4b-7c26-404c-94a2-c963ee358797
- 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
- Marketing end
- 0000-00-00
- Substance
- DEXTROMETHORPHAN
- Active strength
- 30 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 63824-172-63 | 2023-08-24 | C162847 | 48780-1 | 9d75b9d0-46a5-f424-e053-dadaa90a57ce | 28002d7e-335c-43d0-ac88-7bca1efb7ddf |
| 63824-172-65 | 2023-08-24 | C162847 | 48780-1 | 9d75b9d0-46a5-f424-e053-dadaa90a57ce | 28002d7e-335c-43d0-ac88-7bca1efb7ddf |
| 63824-172-63 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-46a5-f424-e053-dadaa90a57ce | 28002d7e-335c-43d0-ac88-7bca1efb7ddf |
| 63824-172-65 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-46a5-f424-e053-dadaa90a57ce | 28002d7e-335c-43d0-ac88-7bca1efb7ddf |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-172-63 | ML - Milliliter | 63824-172 | d072cd6c-371b-475e-b764-697fe8c81a5e | 1 | 2012-07-24 |
| 63824-172-65 | ML - Milliliter | 63824-172 | 7b8e5c0f-75f1-4eb6-8980-0a79e87827e4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |