TYLENOL Cold Plus Flu
- Product NDC
- 85237-1956
- Requested package NDC
- 85237-1956-3
- 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 |
|---|---|---|---|---|---|---|
| Menthol Cough Drops | MENTHOL | Target Corporation Inc. | eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a | 2025-01-26 | Warnings | M012 |
| Walgreens Menthol Cough Drops | MENTHOL | Walgreens | 2c62f690-8dfb-d28e-e063-6394a90a45a2 | 2025-01-23 | Warnings | M012 |
| Walgreens Cherry Cough Drops | MENTHOL | Walgreens | 2c65d836-e724-50d6-e063-6394a90a0827 | 2025-01-23 | Warnings | M012 |
| Walgreens Honey Lemon Cough Drops | MENTHOL | Walgreens | 2c67424c-2fb0-cc15-e063-6394a90a02ca | 2025-01-23 | Warnings | M012 |
| Pharmacys Prescription Analgesic Gel | MENTHOL | American Consumer Products Corp | 6f0725f2-833f-f3a0-e053-2a91aa0a3911 | 2025-01-23 | Warnings | M012 |
| Pharmacys Prescription Vapor Rub | MENTHOL | American Consumer Products Corp | 6ef328ff-f5c3-515d-e053-2a91aa0a32d3 | 2025-01-23 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Best Choice | 0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d | 2025-01-22 | Warnings | M012 |
| GOOD REMEDIES Allergy Relief SOFTGEL | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 26a02737-2cfd-769f-e063-6394a90af352 | 2025-01-22 | Warnings | M012 |
| Pharbechlor | CHLORPHENIRAMINE MALEATE 4MG | Ulai Health LLC | 6a1a5cef-e946-4ba8-9402-557c6adf45f9 | 2025-01-20 | Warnings | M012 |
| Pharbinex | GUAIFENESIN 400MG | Ulai Health LLC | 4eafa81a-aeee-4c97-85d6-594902b10919 | 2025-01-20 | M012 | |
| Pharbinex-PE | GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG | Ulai Health LLC | e459bb83-b1d6-42fc-aa46-99ad117e6144 | 2025-01-20 | M012 | |
| Pharbinex-DM | GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG | Ulai Health LLC | af80d10e-3fb2-405a-a803-1f876b8dcd10 | 2025-01-20 | M012 | |
| Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Bayer HealthCare LLC. | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 2025-01-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a23a6db6-4585-2882-e053-2a95a90ab01a | 2025-01-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold Night PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | fc754dff-cecd-fc6b-e053-6394a90ab371 | 2025-01-17 | Warnings | M012 |
| Kroger DayTime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | The Kroger Co. | 2499210b-c162-76b9-e063-6294a90adbc3 | 2025-01-17 | Warnings | M012 |
| Childrens Multi Symptom Cold Very Berry | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS | 2a849ae9-338f-4642-e063-6394a90a1ca4 | 2025-01-17 | Warnings | M012 |
| Kroger NightTime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | The Kroger Co. | 24a73de3-e9eb-4cd4-e063-6394a90aa263 | 2025-01-17 | Warnings | M012 |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HCL ORAL | Everpharm LLC | d7aaf874-69ac-49cf-93be-6d4a38b9a557 | 2025-01-16 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | 204a7fc4-142d-45fd-8a77-0612857132be | 2025-01-16 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 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 |