Delsym (Dextromethorphan)
- Product NDC
- 63824-177
- 11-digit product format
- 638240177
- Labeler code
- 63824
- Product ID
- 63824-177_51b62d53-491c-8ba5-e063-6394a90a1821
- 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
- 2011-08-19
- 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 (Dextromethorphan)
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN | 30 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7355X3ROTS |
| Rxcui | 1373045, 1373128 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63824-177-63 | Delsym (Dextromethorphan) | 89 mL in 1 BOTTLE | SUSPENSION, EXTENDED RELEASE | 89 | | 8 |
| 63824-177-63 | Delsym (Dextromethorphan) | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | | 8 |
| 63824-177-65 | Delsym (Dextromethorphan) | 148 mL in 1 BOTTLE | SUSPENSION, EXTENDED RELEASE | 148 | | 8 |
| 63824-177-65 | Delsym (Dextromethorphan) | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Dextromethorphan | ACTIVE INGREDIENT | 7355X3ROTS | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| ethylcelluloses | INACTIVE INGREDIENT | 7Z8S9VYZ4B | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| FD&C yellow no. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| high fructose corn syrup | INACTIVE INGREDIENT | XY6UN3QB6S | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| Polistirex | INACTIVE INGREDIENT | 5H9W9GTW27 | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| polyethylene glycol 3350 | INACTIVE INGREDIENT | G2M7P15E5P | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| tragacanth | INACTIVE INGREDIENT | 2944357O2O | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
| xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63824-177 | DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RB HEALTH (US) LLC] | 7 | Current NDC, Legacy NDC, 4 package rows | 20240410_ce4b477c-430e-40a3-b247-b3914ef17793.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63824-177-63 | 63824017763 | 1 BOTTLE in 1 CARTON (63824-177-63) / 89 mL in 1 BOTTLE | 1 bottle | 2011-08-19 | 0000-00-00 | No | No | Current |
| 63824-177-65 | 63824017765 | 1 BOTTLE in 1 CARTON (63824-177-65) > 148 mL in 1 BOTTLE | 1 bottle | 2017-07-01 | 0000-00-00 | No | No | Current |