Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat and Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime
- Product NDC
- 63824-945
- Requested package NDC
- 63824-945-34
- 11-digit product format
- 638240945
- Labeler code
- 63824
- Product ID
- 63824-945_f937d9c9-9361-49d3-a4df-15bc4c6b25dc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, and Triprolidine Hydrochloride
- Dosage form
- KIT
- Labeler
- RB Health (US) LLC
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2020-08-01
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 | 63824-945 | 63824-945-34 | I | Inactivated by FDA | 2026-10-15 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63824-945-34 | 2025-01-30 | C162847 | 48780-1 | d6a99b39-76f3-a426-e053-dadaa90af4c2 | Mucinex® Children's FreeFrom Multi-Symptom Cold, Flu & Sore Throat and Mucinex® Children's FreeFrom Multi-Symptom Cold & Flu Nighttime |
| 63824-945-34 | 2023-01-17 | C162847 | 48780-1 | d6a99b39-76f3-a426-e053-dadaa90af4c2 | Mucinex® Children's FreeFrom Multi-Symptom Cold, Flu & Sore Throat and Mucinex® Children's FreeFrom Multi-Symptom Cold & Flu Nighttime |
| 63824-945-34 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-76f3-a426-e053-dadaa90af4c2 | Mucinex® Children's FreeFrom Multi-Symptom Cold, Flu & Sore Throat and Mucinex® Children's FreeFrom Multi-Symptom Cold & Flu Nighttime |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-945-34 | Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat and Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime | 1 in 1 CARTON | KIT | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-945 | MUCINEX CHILDRENS FREEFROM MULTI-SYMPTOM COLD, FLU AND SORE THROAT AND MUCINEX CHILDRENS FREEFROM MULTI-SYMPTOM COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC] | 2 | Legacy NDC, 1 package rows | 20230118_b59c1ef6-6ae5-412e-8f91-907154666224.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2288826 | {1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack | GPCK | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 2288826 | 1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) Pack | PSN | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 2173662 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution | PSN | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 1043543 | dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 1116572 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 2173662 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution | SCD | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 1043543 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 2288826 | 1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG per 20 ML Oral Solution) Pack | SY | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 1116572 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 2173662 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG per 10 mL Oral Solution | SY | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 2173662 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution | SY | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 1116572 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 2173662 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution | SY | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 1043543 | dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
| 1043543 | dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | b59c1ef6-6ae5-412e-8f91-907154666224 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-945-34 | 63824094534 | 1 KIT in 1 CARTON (63824-945-34) * 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE | 1 kit | 2020-08-01 | 0000-00-00 | No | No | Current |