Childrens Delsym
- Product NDC
- 63824-212
- Requested package NDC
- 63824-212-64
- 11-digit product format
- 638240212
- Labeler code
- 63824
- Product ID
- 63824-212_51b5ee68-a8ce-3f52-e063-6394a90afa3c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-03-18
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Childrens Delsym
- Brand name suffix
- Cough Plus Cold Night Time
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/10mL |
| DIPHENHYDRAMINE HYDROCHLORIDE | 12.5 mg/10mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/10mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1375932 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 00689aa5-ed39-4c9a-92b8-105d2c0e2e15 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 63824-212-64 | 2020-05-06 | Children's Delsym ® Cough Plus Cold Night Time |
| 63824-212-64 | 2020-05-06 | Children's Delsym ® Cough Plus Cold Night Time |
| 63824-212-66 | 2020-05-06 | Children's Delsym ® Cough Plus Cold Night Time |
| 63824-212-66 | 2020-05-06 | Children's Delsym ® Cough Plus Cold Night Time |
| 63824-212-64 | 2020-01-31 | Children's Delsym ® Cough Plus Cold Night Time |
| 63824-212-64 | 2020-01-31 | Children's Delsym ® Cough Plus Cold Night Time |
| 63824-212-66 | 2020-01-31 | Children's Delsym ® Cough Plus Cold Night Time |
| 63824-212-66 | 2020-01-31 | Children's Delsym ® Cough Plus Cold Night Time |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-212-64 | Childrens DelsymCough Plus Cold Night Time | 1 in 1 CARTON | SOLUTION | 1 | 10 | |
| 63824-212-64 | Childrens DelsymCough Plus Cold Night Time | 118 mL in 1 BOTTLE | SOLUTION | 118 | 10 | |
| 63824-212-66 | Childrens DelsymCough Plus Cold Night Time | 180 mL in 1 BOTTLE | SOLUTION | 180 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-212-66 | ML - Milliliter | 63824-212 | 9e80fb7d-fee3-4ba7-8b32-f18139897a92 | 1 | 2013-12-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-212 | CHILDRENS DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RB HEALTH (US) LLC] | 8 | Current NDC, Legacy NDC, 3 package rows | 20241220_00689aa5-ed39-4c9a-92b8-105d2c0e2e15.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Daytime Nighttime Intense Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreen Company | 03aa43fd-4962-4c2c-9edd-e422a629a0e3 | 2026-08-06 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | f311b56f-b959-4070-9b23-82c642dd98b8 | 2026-08-06 | Warnings | M012 |
| Cold Relief Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 2026-08-06 | Warnings | M012 |
| Eucamint | MENTHOL, CAMPHOR | Indiana Botanic Gardens | d79bc8de-9efb-4996-a55c-accda0f8edb2 | 2026-08-06 | Warnings | M012 |
| DRX CHOICE Daytime and Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Raritan Pharmaceuticals Inc | b745f45d-2042-4daa-9932-241836d7734b | 2026-08-06 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | NUVICARE LLC | 6713fdff-0e4e-4a9d-b218-34f786339c57 | 2026-08-06 | Warnings | M012 |
| Daytime Cold, Nighttime Cold multi-symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 3b462a5d-d48b-4b73-b5d4-d7944730bbdd | 2026-08-06 | Warnings | M012 |
| Sinufrin Quick Relief Decongestant | SINUFRIN | Neilmed pharmaceuticals Inc. | 0c36a34e-462d-713c-e063-6294a90a1776 | 2026-08-05 | Warnings | M012 |
| No Drip | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals Inc | e9b799ad-9164-7f30-e053-2a95a90a00c5 | 2026-08-05 | Warnings | M012 |
| DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreen Company | 78edeb7a-4712-4f04-9d76-d5b2d20ce76d | 2026-08-04 | Warnings | M012 |
| CareOne Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | American Sales Company | c9342ad2-84dc-4f4c-9b05-c6e5c1c7989e | 2026-08-04 | Warnings | M012 |
| dg health cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp Inc | 3d8ce88e-9f40-4b58-a811-160ddbfb8112 | 2026-08-04 | Warnings | M012 |
| ValuRx Dye Free Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Shield Pharmaceuticals Corp | ca60a413-b02e-48ce-985d-4d415780c679 | 2026-08-04 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 150b68ba-3ed4-4533-9118-74e76eaf6e48 | 2026-08-04 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | ce393bff-498b-42e6-a41c-bbfbc58fb42c | 2026-08-04 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 3b8662bf-3abb-4e54-af9c-5fa1d2e19003 | 2026-08-04 | Warnings | M012 |
| Mucus Relief PE | GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | cb1c1922-5dc6-520d-e77e-e951726d9701 | 2026-08-04 | Warnings | M012 |
| Chest Congestion Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | DOLGENCORP, LLC | da053bc3-e790-4ae9-a406-2629640e97e7 | 2026-08-04 | Warnings | M012 |
| Cold and Flu plus Congestion Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WALMART INC. | 1236b463-0073-44b5-a516-5b7c06a40887 | 2026-08-04 | Warnings | M012 |
| daytime nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | 80aae1c3-a616-442b-842e-177db957a69c | 2026-08-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1375932 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 00689aa5-ed39-4c9a-92b8-105d2c0e2e15 | 10 |
| 1375932 | acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 00689aa5-ed39-4c9a-92b8-105d2c0e2e15 | 10 |
| 1375932 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 00689aa5-ed39-4c9a-92b8-105d2c0e2e15 | 10 |
| 1375932 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 00689aa5-ed39-4c9a-92b8-105d2c0e2e15 | 10 |
| 1375932 | APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 00689aa5-ed39-4c9a-92b8-105d2c0e2e15 | 10 |
| 1375932 | APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 00689aa5-ed39-4c9a-92b8-105d2c0e2e15 | 10 |
| 1375932 | APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 00689aa5-ed39-4c9a-92b8-105d2c0e2e15 | 10 |
| 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 |
|---|---|---|---|---|---|---|---|---|
| 63824-212-64 | 63824021264 | 1 BOTTLE in 1 CARTON (63824-212-64) / 118 mL in 1 BOTTLE | 1 bottle | 2017-06-09 | 0000-00-00 | No | No | Current |