Delsym
- Product NDC
- 17856-0172
- 11-digit product format
- 178560172
- Labeler code
- 17856
- Product ID
- 17856-0172_a4b63a00-f1e7-4954-98ad-b2b459e82ef1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan
- Dosage form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- NDA018658
- Marketing category
- NDA
- Marketing start
- 2018-12-17
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- 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 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 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 |
|---|---|---|---|---|---|
| 17856-0172-3 | 2024-04-19 | C162847 | 48780-1 | 9d75b9cf-e8ac-f424-e053-dadaa90a57ce | Delsym 12 Hour Cough Relief Grape |
| 17856-0172-4 | 2024-04-19 | C162847 | 48780-1 | 9d75b9cf-e8ac-f424-e053-dadaa90a57ce | Delsym 12 Hour Cough Relief Grape |
| 17856-0172-3 | 2024-01-30 | C162847 | 48780-1 | 9d75b9cf-e8ac-f424-e053-dadaa90a57ce | Delsym 12 Hour Cough Relief Grape |
| 17856-0172-4 | 2024-01-30 | C162847 | 48780-1 | 9d75b9cf-e8ac-f424-e053-dadaa90a57ce | Delsym 12 Hour Cough Relief Grape |
| 17856-0172-1 | 2020-08-21 | C162847 | 48780-1 | 9d75b9cf-e8ac-f424-e053-dadaa90a57ce | Delsym 12 Hour Cough Relief Grape |
| 17856-0172-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e8ac-f424-e053-dadaa90a57ce | Delsym 12 Hour Cough Relief Grape |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-0172-1 | Delsym | 10 mL in 1 CUP, UNIT-DOSE | SUSPENSION, EXTENDED RELEASE | 10 | 5 | |
| 17856-0172-1 | Delsym | 72 in 1 BOX, UNIT-DOSE | SUSPENSION, EXTENDED RELEASE | 72 | 5 | |
| 17856-0172-2 | Delsym | 72 in 1 BOX, UNIT-DOSE | SUSPENSION, EXTENDED RELEASE | 72 | 5 | |
| 17856-0172-2 | Delsym | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION, EXTENDED RELEASE | 5 | 5 | |
| 17856-0172-3 | Delsym | 1 in 1 CUP, UNIT-DOSE | SUSPENSION, EXTENDED RELEASE | 1 | 5 | |
| 17856-0172-4 | Delsym | 1 in 1 CUP, UNIT-DOSE | SUSPENSION, EXTENDED RELEASE | 1 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-0172 | DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORP.] | 5 | Legacy NDC, 6 package rows | 20240420_00f8f5b4-f5a8-4dcf-8133-15964ad4801e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1373128 | Delsym 30 MG in 5 mL 12HR Extended Release Oral Suspension | PSN | 00f8f5b4-f5a8-4dcf-8133-15964ad4801e | 5 |
| 1373045 | dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension | PSN | 00f8f5b4-f5a8-4dcf-8133-15964ad4801e | 5 |
| 1373128 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym] | SBD | 00f8f5b4-f5a8-4dcf-8133-15964ad4801e | 5 |
| 1373045 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension | SCD | 00f8f5b4-f5a8-4dcf-8133-15964ad4801e | 5 |
| 1373128 | Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release Suspension | SY | 00f8f5b4-f5a8-4dcf-8133-15964ad4801e | 5 |
| 1373045 | dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension | SY | 00f8f5b4-f5a8-4dcf-8133-15964ad4801e | 5 |
| 1373045 | dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension | SY | 00f8f5b4-f5a8-4dcf-8133-15964ad4801e | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17856-0172-1 | 17856017201 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0172-1) > 10 mL in 1 CUP, UNIT-DOSE | 2018-12-17 | 0000-00-00 | No | No | Current |
| 17856-0172-2 | 17856017202 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0172-2) > 5 mL in 1 CUP, UNIT-DOSE | 2018-12-17 | 0000-00-00 | No | No | Current |
| 17856-0172-3 | 17856017203 | 1 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0172-3) > 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0172-2) > 5 mL in 1 CUP, UNIT-DOSE | 2022-09-02 | 0000-00-00 | No | No | Current |
| 17856-0172-4 | 17856017204 | 1 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0172-4) > 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0172-1) > 10 mL in 1 CUP, UNIT-DOSE | 2022-09-02 | 0000-00-00 | No | No | Current |