Cold and Flu
- Product NDC
- 42507-522
- Requested package NDC
- 42507-522-40
- 11-digit product format
- 425070522
- Labeler code
- 42507
- Product ID
- 42507-522_e865c4c1-a9a6-47c8-bcbb-2b1f3bec8a25
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-01-10
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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
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
- Cold and Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1113705 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42507-522-30 | Cold and Flu | 177 mL in 1 BOTTLE | SOLUTION | 177 | 7 | |
| 42507-522-34 | Cold and Flu | 237 mL in 1 BOTTLE | SOLUTION | 237 | 7 | |
| 42507-522-38 | Cold and Flu | 296 mL in 1 BOTTLE | SOLUTION | 296 | 7 | |
| 42507-522-40 | Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 7 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Mucinex Childrens Stuffy Nose and Chest Congestion | GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 7354f57c-0ecf-481f-9482-0040c90c4350 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 5bda415d-739f-4ca5-b5b2-07c14a81863b | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Multi-Symptom Cold and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 8f3eb5c5-832e-4806-b3da-ef112cf55dcf | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDE | Reckitt Benckiser LLC | e3aea6df-37a4-43c5-a192-a902cbff3f92 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d9e5a8d7-814c-4ab1-bb05-e4cb9155978e | 2026-05-18 | Warnings | M012 |
| 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 | Reckitt Benckiser LLC | c7ab5201-8550-4bf4-957c-c8f049aeaa4a | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 84e7be8f-2785-45ef-9c44-de05394fcd99 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 771d7fd8-184f-48a3-90ed-e8f00159d97e | 2026-05-18 | Warnings | M012 |
| MUCINEX Childrens Stuffy Nose | OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | de1c0abd-1644-4351-8106-e9df6ca5c142 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Fever Sore Throat and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 1538a75d-582a-9501-e063-6394a90a6c55 | 2026-05-18 | Warnings | M012 |
| Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Reckitt Benckiser LLC | 19105007-0193-0764-e063-6294a90a01a4 | 2026-05-18 | Warnings | M012 |
| Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and Flu | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN,TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 34fd2458-9acd-cdf7-e063-6394a90a3d0a | 2026-05-18 | Warnings | M012 |
| MUCINEX FAST-MAX NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3a24b06c-00a6-c2ef-e063-6294a90a4d72 | 2026-05-18 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Reckitt Benckiser LLC | 14be3ab0-d6ae-e342-e063-6294a90ab851 | 2026-05-18 | Warnings | M012 |
| Banophen | DIPHENHYDRAMINE HCL | Bryant Ranch Prepack | 20f00537-2c8a-45d1-8e5f-ec276d0a47b6 | 2026-05-18 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | 38df2308-f6f9-4476-ad34-4b5bc5f9fdf2 | 2026-05-18 | Warnings | M012 |
| Allergy Plus Headache Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALMART INC. | 88e3b969-79d0-4e64-95c0-c5cfd41e365f | 2026-05-18 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | db264d2f-bf81-4da2-8595-2bfa1e4ba2f1 | 2026-05-18 | Warnings | M012 |
| equate nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c | 2026-05-15 | Warnings | M012 |
| good neighbor pharmacy cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amerisource Bergen | da91e6b6-32ff-44fd-afce-33ea9549554b | 2026-05-15 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 7 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 7 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 7 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 7 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42507-522-40 | 42507052240 | 355 mL in 1 BOTTLE (42507-522-40) | 355 ml | 2014-01-10 | No | No | Current |