Mucinex Childrens Multi-Symptom Cold
- Product NDC
- 63824-949
- 11-digit product format
- 638240949
- Labeler code
- 63824
- Product ID
- 63824-949_521a1ec9-44f7-d14f-e063-6394a90accd6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-03-30
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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 | 63824-949 | 63824-949-15 | D | Discontinued by firm | 2026-10-28 |
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… |
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
- Mucinex Childrens Multi-Symptom Cold
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/5mL |
| GUAIFENESIN | 100 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 771d7fd8-184f-48a3-90ed-e8f00159d97e | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 63824-949-01 | 2020-10-28 | Mucinex® Children's Multi-Symptom Cold |
| 63824-949-15 | 2020-10-28 | Mucinex® Children's Multi-Symptom Cold |
| 63824-949-01 | 2020-09-27 | Mucinex® Children's Multi-Symptom Cold |
| 63824-949-15 | 2020-09-27 | Mucinex® Children's Multi-Symptom Cold |
| 63824-949-01 | 2020-09-25 | Mucinex® Children's Multi-Symptom Cold |
| 63824-949-15 | 2020-09-25 | Mucinex® Children's Multi-Symptom Cold |
| 63824-949-01 | 2020-07-22 | Mucinex® Children's Multi-Symptom Cold |
| 63824-949-15 | 2020-07-22 | Mucinex® Children's Multi-Symptom Cold |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-949-01 | Mucinex Childrens Multi-Symptom Cold | 1 in 1 CARTON | SUSPENSION | 1 | 10 | |
| 63824-949-01 | Mucinex Childrens Multi-Symptom Cold | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 10 | |
| 63824-949-15 | Mucinex Childrens Multi-Symptom Cold | 201 mL in 1 BOTTLE | SUSPENSION | 201 | 10 | |
| 63824-949-15 | Mucinex Childrens Multi-Symptom Cold | 1 in 1 CARTON | SUSPENSION | 1 | 10 | |
| 63824-949-01 | Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack | 1 in 1 CARTON | SUSPENSION | 100 mg in 5mL | 4 | |
| 63824-949-01 | Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack | 118 mL in 1 BOTTLE | SUSPENSION | 236 mL | 100 mg in 5mL | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-949-01 | ML - Milliliter | 63824-949 | b92761ba-ca65-488f-aa2a-4031f8639dcb | 1 | 2020-02-13 |
| 63824-949-15 | ML - Milliliter | 63824-949 | 6710079a-01a4-41db-9e79-01eafa9492e5 | 1 | 2020-03-10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-949 | MUCINEX CHILDRENS MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [RB HEALTH (US) LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20241222_771d7fd8-184f-48a3-90ed-e8f00159d97e.zip |
| 63824-949 | MUCINEX CHILDRENS DAY TIME MULTI-SYMPTOM COLD AND MUCINEX CHILDRENS NIGHT TIME MULTI-SYMPTOM COLD TRIPLE PACK (ACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) KIT [RB HEALTH (US) LLC] | 3 | Current NDC, Legacy NDC | 20241222_c7ab5201-8550-4bf4-957c-c8f049aeaa4a.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 |
|---|---|---|---|---|---|---|
| Family Care Saline | SODIUM CHLORIDE | United Exchange Corp. | 06737393-d4ae-3e7b-e063-6394a90ac19f | 2025-10-31 | Warnings | M012 |
| QUALITY CHOICE Maximum Strength Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | 40416ff5-06e1-97dd-e063-6394a90a2046 | 2025-10-30 | Warnings | M012 |
| Robitussin Maximum Strength Nighttime Cough DM | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 44feee2f-25bc-48d4-8e13-db1d9daaaa90 | 2025-10-30 | Warnings | M012 |
| Robitussin Day and Night Cough Relief DM Max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | b3d02c91-8f79-4eb4-a378-1072474c572c | 2025-10-30 | Warnings | M012 |
| ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7 | 2025-10-30 | Warnings | M012 |
| Endal | TRIPROLIDINE HCL, DEXTROMETHORPHAN HBR | Poly Pharmaceuticals, Inc. | fc5401e2-ed65-72e7-e053-6294a90a81f3 | 2025-10-30 | Warnings | M012 |
| daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | c7cef266-46fc-49ab-a2e7-54fc56298659 | 2025-10-30 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | SAM'S WEST INC | 16592ad7-b7cb-0837-e063-6394a90ae059 | 2025-10-29 | Warnings | M012 |
| Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL | SAFEWAY | 013b94a1-26c7-4371-981a-d1b9d7fd1c98 | 2025-10-29 | Warnings | M012 |
| Better Living | PHENYLEPHRINE HYDROCHLORIDE | BETTER LIVING BRANDS LLC | aea0db7f-e01a-4d8e-9c20-4a5ef4a905d1 | 2025-10-29 | Warnings | M012 |
| AXIM DayTime - Night Time 72 Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | VIVUNT PHARMA LLC | de9eb2d5-ba51-4637-e053-2995a90a0451 | 2025-10-29 | Warnings | M012 |
| Dollar General Vapor Steam | CAMPHOR (SYNTHETIC) | DOLGENCORP, LLC | 86d0f3ac-1359-c2f9-e053-2a91aa0a35d0 | 2025-10-29 | Warnings | M012 |
| Maximum Strength Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Wal-Mart Stores,Inc., | a748d5ab-901c-47bb-8437-997542ecebfe | 2025-10-28 | Warnings | M012 |
| Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom Relief | CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE | WAL-MART STORES,INC. | 68a68574-0fcb-4569-be57-d9aee5f62bea | 2025-10-28 | Warnings | M012 |
| Maximum Strength Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 635009a1-6154-4c62-a4be-d4f32c2cef8d | 2025-10-28 | Warnings | M012 |
| Family Care Nasal Relief | OXYMETAZOLINE HYDROCHLORIDE | United Exchange Corp | 6d0f8e9e-0503-522b-e053-2a91aa0aca35 | 2025-10-28 | Warnings | M012 |
| Family Care Nasal Relief | OXYMETAZOLINE HYDROCHLORIDE | United Exchange Corp | 6d0eef2f-f546-d769-e053-2991aa0a8fe4 | 2025-10-28 | Warnings | M012 |
| Tussin DM Cough and Chest Congestion Adult | DEXTROMETHORPHAN HBR, GUAIFENESIN | P & L Development, LLC | 4af67ba7-8892-442c-b9fb-80aba9140e05 | 2025-10-28 | Warnings | M012 |
| No Drip Nasal Mist Nasal Decongestant Severe Congestion | OXYMETAZOLINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 994fa270-65bb-4097-b88a-d5ce3c0e1c79 | 2025-10-27 | Warnings | M012 |
| Dye Free Childrens Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | WAL-MART STORES INC. | 3652ee94-b762-4100-a305-5acbec5f795a | 2025-10-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2637728 | {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 / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack | GPCK | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 2637728 | 1 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 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 | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 1375932 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 1043543 | dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 1375932 | acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 1043543 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 2637728 | 1 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 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 | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 1375932 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 1375932 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 1375932 | APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 1375932 | APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 1375932 | APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 1043543 | dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 1043543 | dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 6 |
| 2637728 | {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 / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack | GPCK | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
| 2637728 | 1 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 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 | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
| 1375932 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
| 1043543 | dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
| 1375932 | acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
| 1043543 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
| 2637728 | 1 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 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 | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
| 1375932 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
| 1375932 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
| 1375932 | APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
| 1375932 | APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
| 1375932 | APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
| 1043543 | dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
| 1043543 | dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-949-01 | 63824094901 | 1 BOTTLE in 1 CARTON (63824-949-01) / 118 mL in 1 BOTTLE | 1 bottle | 2018-03-30 | 0000-00-00 | No | No | Current |
| 63824-949-15 | 63824094915 | 1 BOTTLE in 1 CARTON (63824-949-15) > 201 mL in 1 BOTTLE | 1 bottle | 2018-03-30 | 0000-00-00 | No | No | Current |