Childrens Delsym
- Product NDC
- 63824-212
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 63824-212 | 63824-212-66 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|
| Sleep Aid NightTime | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 4fff664b-4ff0-4007-95ab-cb273807b9b4 | 2026-08-25 | Warnings | M012 |
| Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | 464534ee-15f8-3af8-e063-6394a90a3f18 | 2026-08-24 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 7d972559-6184-476b-9cbf-1bc5663ea00d | 2026-08-24 | Warnings | M012 |
| DG HEALTH MULTI SYMPTOM SEVERE COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, LLC | 47ddbb0d-0823-4817-9c56-e7fff77d601c | 2026-08-21 | Warnings | M012 |
| Mucus Relief DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | DOLGENCORP, LLC | 5be4e730-3cd6-414e-a23b-f6cad8088750 | 2026-08-21 | Warnings | M012 |
| Mucus Relief DM Cough Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | 6304a581-9238-4539-b157-293fc05c173e | 2026-08-21 | Warnings | M012 |
| Afrin Original Nasal | OXYMETAZOLINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc. | ecfa14b8-a3f3-4569-b489-c9e1a51cf09e | 2026-08-20 | Warnings | M012 |
| CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK | BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL | CVS PHARMACY, INC. | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2026-08-19 | Warnings | M012 |
| CVS Adult Mucus chest congestion | GUAIFENESIN | CVS PHARMACY | bec04049-03b2-4465-9cf5-0ad2ef8014ef | 2026-08-19 | Warnings | M012 |
| CVS Childrens Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | CVS PHARMACY, INC | fe12f3bd-3237-42d1-aec5-c831b9637175 | 2026-08-19 | Warnings | M012 |
| CVS Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY, INC | bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9 | 2026-08-19 | Warnings | M012 |
| CVS Long Acting Cough | DEXTROMETHORPHAN HBR | CVS PHARMACY, INC | 31a7c0e2-af1c-45dd-8a93-e0879cae6005 | 2026-08-19 | Warnings | M012 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | b3baf939-a9fd-47ac-9bc7-68435e32ea1e | 2026-08-19 | Warnings | M012 |
| Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS PHARMACY | 5151127a-4d09-413a-a08b-f76fb77e1188 | 2026-08-19 | Warnings | M012 |
| CVS DT and NT Combo Pack Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | CVS PHARMACY | 360c8c62-0945-4031-b291-d40c4270b940 | 2026-08-19 | Warnings | M012 |
| equate childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | WALMART INC. | 24758ab0-ba08-4b4a-9861-449612bdb89c | 2026-08-19 | Warnings | M012 |
| CVS Adult Mucus plus Chest Congestion | GUAIFENESIN | CVS PHARMACY | 3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a | 2026-08-19 | Warnings | M012 |
| CVS Childrens Cold plus Cough plus Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | CVS | 7dc30e46-e289-40fc-b217-b123fee5daee | 2026-08-19 | Warnings | M012 |
| CVS ADULT COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | CVS PHARMACY | 4490a7e1-d5b9-459c-8751-c24486807981 | 2026-08-19 | Warnings | M012 |
| CVS DayTime and NightTime Value Pack Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | CVS PHARMACY | 4c813cd5-2c97-4fc3-926c-1a0396551a31 | 2026-08-19 | 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 |
| 63824-212-66 | 63824021266 | 180 mL in 1 BOTTLE (63824-212-66) | 180 ml | 2013-03-18 | 0000-00-00 | No | No | Current |