Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time
- Product NDC
- 63824-218
- 11-digit product format
- 638240218
- Labeler code
- 63824
- Product ID
- 63824-218_52d0ff0a-f583-c022-e063-6294a90a259d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- KIT
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-07-01
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9aca1a68-893c-4770-8a48-d5d678058253 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2020-04-08 | Children's Delsym ® Cough Plus ® Chest Congestion DM and Delsym Cough Plus ® Cold Night Time |
| 2020-04-08 | Children's Delsym ® Cough Plus ® Chest Congestion DM and Delsym Cough Plus ® Cold Night Time |
| 2020-01-31 | Children's Delsym ® Cough Plus ® Chest Congestion DM and Delsym Cough Plus ® Cold Night Time |
| 2020-01-31 | Children's Delsym ® Cough Plus ® Chest Congestion DM and Delsym Cough Plus ® Cold Night Time |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-218-22 | Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time | 1 in 1 CARTON | KIT | 1 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-218-22 | ML - Milliliter | 63824-218 | 9e31e9aa-fc0b-45d8-bd47-7ba716d0f9f2 | 1 | 2019-08-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-218 | CHILDRENS DELSYM COUGH PLUS CHEST CONGESTION DM AND DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241222_9aca1a68-893c-4770-8a48-d5d678058253.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2637730 | {1 (acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) } Pack | GPCK | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
| 2637730 | 1 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG in 5 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution) Pack | PSN | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
| 1375932 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
| 1020138 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution | PSN | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
| 1375932 | acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
| 1020138 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
| 2637730 | 1 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) Pack | SY | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
| 1375932 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
| 1375932 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
| 1375932 | APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
| 1375932 | APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
| 1375932 | APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
| 1020138 | dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution | SY | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
| 1020138 | dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 9aca1a68-893c-4770-8a48-d5d678058253 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-218-22 | 63824021822 | 1 KIT in 1 CARTON (63824-218-22) * 118 mL in 1 BOTTLE * 118 mL in 1 BOTTLE | 1 kit | 2017-07-01 | 0000-00-00 | No | No | Current |