TYLENOL Cold Plus Flu
- Product NDC
- 85237-1956
- 11-digit product format
- 852371956
- Labeler code
- 85237
- Product ID
- 85237-1956_55bdcb18-a65a-d916-e063-6294a90a7f17
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Select Consumer Group
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-09-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
- 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
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
- TYLENOL Cold Plus Flu
- Brand name suffix
- Severe
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1110988 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 55bddbea-5ad9-6a18-e063-6394a90a461d | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Maximum Strength Cold Tabs | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | JHK DBA American Safety & First Aid | e7d4fe9a-eb09-4266-90c9-290f61ce6ad0 | 2024-07-15 | Warnings | M012 |
| ACTIDOM DA | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 7797c22e-ffeb-4798-9fb6-aa64cf077ba7 | 2024-07-15 | Warnings | M012 |
| Nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1cf3064d-4ddd-63b9-e063-6294a90aa547 | 2024-07-11 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1ccbdb53-3f70-28da-e063-6394a90a9ae0 | 2024-07-09 | Warnings | M012 |
| AXIV Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 1cd2a6f1-31ad-e507-e063-6394a90aba58 | 2024-07-09 | Warnings | M012 |
| Poly Hist Forte | DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 8aa0015b-8fc1-7951-e053-2a95a90a8e72 | 2024-07-09 | Warnings | M012 |
| DECONEX DMX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 8aab8e5c-1633-2e5a-e053-2a95a90adcc5 | 2024-07-09 | Warnings | M012 |
| Deconex IR | GUAIFENESIN AND PHENYLEPHRINE HCL | Poly Pharmaceuticals, Inc. | 4710095e-3dae-4a39-8a98-873012e1f003 | 2024-07-09 | Warnings | M012 |
| Diabetic Tussin Sore Throat and Cough Cherry | BENZOCAINE AND DEXTROMETHORPHAN HBR | MEDTECH PRODUCTS INC | e9327079-e0fc-4c95-b1d5-bc1b74870c9b | 2024-07-09 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Rite Aid Corporation | fac859a4-e23a-4879-af6c-26368455506d | 2024-07-05 | Warnings | M012 |
| Severe Throat Drops | MENTHOL ICE | Target Corporation Inc. | 1876b221-fa60-5269-e063-6394a90a6963 | 2024-07-04 | Warnings | M012 |
| Daytime and Nighttime Cherry Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0bf911bf-eafe-fe46-e063-6294a90a3903 | 2024-07-03 | Warnings | M012 |
| Family Wellness Effervescent Cold Relief Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Family Dollar Services, Inc. | 4e13511b-fbb5-2523-e054-00144ff88e88 | 2024-07-03 | Warnings | M012 |
| Nighttime Cherry Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | TARGET CORPORATION | 1c3f6cbf-a00d-45b9-e063-6394a90a797c | 2024-07-02 | Warnings | M012 |
| Cold Terminator Cold Relief | PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Wildman Business Group | e8538d9c-f9ba-40b1-b60f-f57921f39b64 | 2024-07-01 | Warnings | M012 |
| Nighttime Severe Honey Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1c02e465-8750-a088-e063-6394a90a8efb | 2024-06-29 | Warnings | M012 |
| ACTIDOM DMX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 0166322e-7dbb-4658-a5c5-1d0525bb7655 | 2024-06-28 | Warnings | M012 |
| ACTINEL DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | ACTIPHARMA, LLC | 16660d82-524b-42ca-8581-48237caa13b2 | 2024-06-28 | Warnings | M012 |
| PurgenLabs Acetaminophen | ACTAMINOPHEN | Advanced Rx LLC | 915c4608-af1b-4119-8291-4ce9fd701d76 | 2024-06-28 | Warnings | M012 |
| Daytime Ultra Concentrated Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL | TARGET CORPORATION | 1bc90b2f-612c-e977-e063-6294a90a40b4 | 2024-06-26 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85237-1956-1 | 85237195601 | 1 POUCH in 1 BLISTER PACK (85237-1956-1) / 2 TABLET, FILM COATED in 1 POUCH (85237-1956-0) | 1 pouch | 2024-09-11 | No | No | Current |
| 85237-1956-2 | 85237195602 | 2 POUCH in 1 BLISTER PACK (85237-1956-2) / 2 TABLET, FILM COATED in 1 POUCH (85237-1956-0) | 2 pouch | 2024-09-11 | No | No | Current |
| 85237-1956-3 | 85237195603 | 20 POUCH in 1 BOX (85237-1956-3) / 2 TABLET, FILM COATED in 1 POUCH (85237-1956-0) | 20 pouch | 2024-09-11 | No | No | Current |
| 85237-1956-4 | 85237195604 | 25 POUCH in 1 BOX (85237-1956-4) / 2 TABLET, FILM COATED in 1 POUCH (85237-1956-0) | 25 pouch | 2024-09-11 | No | No | Current |
| 85237-1956-6 | 85237195606 | 50 POUCH in 1 BOX (85237-1956-6) / 2 TABLET, FILM COATED in 1 POUCH (85237-1956-0) | 50 pouch | 2024-09-11 | No | No | Current |
| 85237-1956-7 | 85237195607 | 3 POUCH in 1 BLISTER PACK (85237-1956-7) / 2 TABLET, FILM COATED in 1 POUCH (85237-1956-0) | 3 pouch | 2024-09-11 | No | No | Current |