Mucinex Childrens Mighty Chews Night Time Cold and Flu
- Product NDC
- 72854-085
- 11-digit product format
- 728540085
- Labeler code
- 72854
- Product ID
- 72854-085_51bad8ca-7226-ecef-e063-6394a90a8fc3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-06-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN
- Active strength
- 5; 3.125; 162.5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | 72854-085 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | ||
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 72854-085 | 72854-085-16 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
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 Mighty Chews Night Time Cold and Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/1 |
| DOXYLAMINE SUCCINATE | 3.125 mg/1 |
| ACETAMINOPHEN | 162.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2715863 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2ce31244-9c6c-b7dd-e063-6394a90a31a8 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72854-085-16 | Mucinex Childrens Mighty Chews Night Time Cold and Flu | 16 in 1 BOTTLE | TABLET, CHEWABLE | 16 | 5 |
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 |
|---|---|---|---|---|---|---|
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 54254b61-7861-4eeb-bd3c-54fd5266f4a7 | 2026-06-08 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Major Pharmaceuticals | aa662428-e61f-4e22-af4d-8cf63df68c99 | 2026-06-08 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN, GUAIFENESIN AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | TARGET CORPORATION | 47a218a0-6395-36bd-e063-6394a90a265a | 2026-06-05 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL | TARGET CORPORATION | 4779288a-9850-8490-e063-6394a90abe51 | 2026-06-05 | Warnings | M012 |
| Mucinex Fast-Max DM Max and Mucinex Fast-Max Nighttime DM Max Value Pack | DEXTROMETHORPHAN HBR, GUAIFENESIN AND TRIPROLIDINE HCL | Reckitt Benckiser LLC | 4df37cfb-299f-661f-e063-6394a90ab337 | 2026-06-04 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 53715ea4-42b3-5887-e063-6294a90a4249 | 2026-06-04 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Chain Drug Marketing Association, Inc. | b0d38db9-22a9-4dd8-8e0f-dd81805e724b | 2026-06-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS PHARMACY | 65d4d7ea-c080-404e-9836-7d6bdcc5ea7d | 2026-06-04 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | fe9d6a6e-38a1-44ae-a30f-596c5ec7d057 | 2026-06-03 | Warnings | M012 |
| Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | b0c1d635-0f85-433a-b479-51c68d259faa | 2026-06-03 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | Walgreen Company | de4e8af4-d3d0-44b3-aea3-79016803ccdc | 2026-06-03 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR AND GUAIFENESIN | ARMY AND AIR FORCE EXCHANGE SERVICE | dc0a3761-bbe2-4261-a183-594f5fb12b0b | 2026-06-03 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | WALMART INC. | f278cc81-65b2-4e45-be5b-41152cbb67c4 | 2026-06-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Family Dollar Services Inc | 358ba91d-06a4-49c9-994d-4e4bf9499dcd | 2026-06-03 | Warnings | M012 |
| GUAIFENESIN DM | GUAIFENESIN AND DEXTROMETHORPHAN | Cardinal Health 107, LLC | c5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed | 2026-06-02 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5349dbde-730c-610f-e063-6394a90a952a | 2026-06-02 | Warnings | M012 |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | Cardinal Health 107, LLC | a9130f36-4761-4e6b-a383-eca3db06ea93 | 2026-06-02 | Warnings | M012 |
| Topcare Day Time Nite Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Topco Associates LLC | aed387e0-5a8b-4caf-a373-3e04496a4983 | 2026-06-02 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid Day | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 53371691-2510-5039-e063-6394a90a6ea9 | 2026-06-01 | Warnings | M012 |
| Allegra Allergy 24 hour | FEXOFENADINE HYDROCHLORIDE | Select Consumer Group | 2de81a41-8488-7e39-e063-6294a90a394b | 2026-06-01 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2715863 | acetaminophen 162.5 MG / dextromethorphan HBr 5 MG / doxylamine succinate 3.125 MG Chewable Tablet | PSN | 2ce31244-9c6c-b7dd-e063-6394a90a31a8 | 5 |
| 2715863 | acetaminophen 162.5 MG / dextromethorphan hydrobromide 5 MG / doxylamine succinate 3.125 MG Chewable Tablet | SCD | 2ce31244-9c6c-b7dd-e063-6394a90a31a8 | 5 |
| 2715863 | APAP 162.5 MG / dextromethorphan hydrobromide 5 MG / doxylamine succinate 3.125 MG Chewable Tablet | SY | 2ce31244-9c6c-b7dd-e063-6394a90a31a8 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 72854-085-16 | 72854008516 | 16 TABLET, CHEWABLE in 1 BOTTLE (72854-085-16) | 2025-06-01 | No | No | Current |