Mucinex Childrens
- Product NDC
- 63824-955
- 11-digit product format
- 638240955
- Labeler code
- 63824
- Product ID
- 63824-955_5219ef25-dd24-93da-e063-6394a90ae94a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Acetaminophen, and Diphenhydramine Hydrochloride
- Dosage form
- KIT
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-01-21
- 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
- Mucinex Childrens
- Brand name suffix
- Day Time Multi-Symptom Cold and Night Time Multi-Symptom Cold
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e3aea6df-37a4-43c5-a192-a902cbff3f92 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-955-74 | Mucinex ChildrensDay Time Multi-Symptom Cold and Night Time Multi-Symptom Cold | 1 in 1 CARTON | KIT | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-955-74 | ML - Milliliter | 63824-955 | 71fc10eb-6e50-428c-a90d-3786f86e5e09 | 1 | 2020-03-10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-955 | MUCINEX CHILDRENS DAY TIME MULTI-SYMPTOM COLD AND NIGHT TIME MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241222_e3aea6df-37a4-43c5-a192-a902cbff3f92.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 |
|---|---|---|---|---|---|---|
| AXIM DM Max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | VIVUNT PHARMA LLC | 0e7424ea-461f-5ead-e063-6294a90a41b6 | 2024-01-05 | Warnings | M012 |
| AXIM Night Time - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 0e740063-80d5-c48b-e063-6394a90a3b30 | 2024-01-05 | Warnings | M012 |
| AXIM DayTime - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | VIVUNT PHARMA LLC | 0e742e10-daea-6443-e063-6294a90ab5af | 2024-01-05 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc | 2024-01-05 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | A-S Medication Solutions | fa12a5a8-bf2d-4991-9d54-9c519e8e04cd | 2024-01-04 | Warnings | M012 |
| NASAL DECONGESTANT PE 10mg | PHENYLPHRINE HCL | YYBA CORP | 05824fc4-ef3f-4ebb-b601-252f76ad60ef | 2024-01-03 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | Proficient Rx LP | 5943d975-77e4-4cbd-b2d9-d699052fe82a | 2024-01-01 | Warnings | M012 |
| Coricidin HBP Cold and Flu | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | Proficient Rx LP | ac79a7dd-c26e-47d2-8fb9-768d2d09e507 | 2024-01-01 | Warnings | M012 |
| Oxymethazoline HCL | OXYMETHAZOLINE HCL | Proficient Rx LP | 96883e5f-18b5-4c1c-b984-756cb86be6ff | 2024-01-01 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | Proficient Rx LP | 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 | 2024-01-01 | Warnings | M012 |
| Good Neighbor Pharmacy Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Proficient Rx LP | 9e067482-8735-4476-a82e-438dd24d4289 | 2024-01-01 | Warnings | M012 |
| XL-3 Day Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | AptaPharma Inc. | 94e02be4-b8a6-422a-8f66-e6a69e924b2c | 2023-12-30 | Warnings | M012 |
| TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM | DEXTROMETHORPHAN HYDROBROMIDE | AptaPharma Inc. | 8a4c55d0-c472-4e89-9fdb-17ecf0af4856 | 2023-12-30 | Warnings | M012 |
| XL-3 Xtreme | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | AptaPharma Inc. | dff79e0b-edf0-4dd3-a722-fd9beecd6293 | 2023-12-30 | Warnings | M012 |
| TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Salado Sales, Inc. | e25727d0-7dd7-4ef5-b064-7938679f075f | 2023-12-29 | Warnings | M012 |
| Maximum Strength DM MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | H E B | bb56d09d-ecb0-469e-a16f-f9f1a48942a8 | 2023-12-29 | Warnings | M012 |
| Childrens Cough Mucus Relief | DEXTROMETHORPHANN HBR, GUAIFENESIN | Discount Drug Mart | 2c27aca4-e1e2-419a-84c4-857718ca49da | 2023-12-29 | Warnings | M012 |
| Night Time Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | de2b2e34-62a5-451f-ab68-531d1c9d4d82 | 2023-12-29 | Warnings | M012 |
| H E B MAX SEVERE CONGESTION and COUGH Maxium Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | d2b016ee-5329-45bf-9d71-d626204169cf | 2023-12-29 | Warnings | M012 |
| Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | DeMoulas Market Basket | e92d2f64-9690-42d3-b787-cafade3a8999 | 2023-12-29 | 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-955-74 | 63824095574 | 1 KIT in 1 CARTON (63824-955-74) * 118 mL in 1 BOTTLE * 118 mL in 1 BOTTLE | 1 kit | 2019-01-21 | 0000-00-00 | No | No | Current |