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 |
|---|---|---|---|---|---|---|
| Cold and Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TopCo Associates LLC | e07d880b-a12a-4e5e-94c0-bd36bcfe738c | 2024-12-03 | Warnings | M012 |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCARE | bd0a3679-1f7c-4c41-e053-2995a90a8fcb | 2024-12-03 | Warnings | M012 |
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | bd09e4f3-3211-8c08-e053-2a95a90a73f9 | 2024-12-03 | Warnings | M012 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | b373a3a8-68c4-0187-e053-2995a90aad62 | 2024-12-03 | Warnings | M012 |
| Mucus Relief Cold and Flu All In One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCARE | a1b281ec-fd42-963c-e053-2a95a90a4b71 | 2024-12-03 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | b3366ad4-5ef4-eb70-e053-2995a90acf33 | 2024-12-03 | Warnings | M012 |
| Meijer Medicated Chest Rub, 3.53 oz. Lavender | MENTHOL, CAMPHOR, EUCALYPTUS OIL | Meijer Distribution | 22516f25-b8aa-7511-e063-6394a90a6125 | 2024-12-03 | Warnings | M012 |
| Tenalif Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05cd9513-1a42-e990-e063-6294a90a57df | 2024-12-03 | Warnings | M012 |
| Tenalif Multi Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05cd94e7-1808-3bb3-e063-6294a90a4140 | 2024-12-03 | Warnings | M012 |
| Nasal Decongestant PE and Pain Relief Plus Mucus Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Winco Foods, LLC | 31531f90-8933-46ab-b722-cb63e7738639 | 2024-12-03 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | WINCO FOODS, LLC | f45f3ab4-5e10-3004-e053-2a95a90a0cb4 | 2024-12-03 | Warnings | M012 |
| good sense allergy | DIPHENHYDRAMINE HCL | NuCare Pharmaceuticals, Inc. | 2861b801-e778-822d-e063-6394a90aa1a8 | 2024-12-03 | Warnings | M012 |
| Sinus plus Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | fe0cf681-f42c-430c-8429-f7ba4bc5a976 | 2024-12-02 | Warnings | M012 |
| Allergy Multisymptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 5a5aa2ee-51b7-4698-bb27-3fb9d01bbea5 | 2024-12-02 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association | 0ea270b7-9c28-49fb-9615-c4afdbdbc8f1 | 2024-12-02 | Warnings | M012 |
| Head Congestion Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 0955d856-cc4e-4ef2-8bc0-1a632a5b5f79 | 2024-12-02 | Warnings | M012 |
| Head Congestion Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 40c9c90d-6c9e-40d0-921d-1fd34eff90bb | 2024-12-02 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 3d068d30-9a00-49d7-bbe9-d6b53c19e86d | 2024-12-02 | Warnings | M012 |
| Diphenhydramine | DIPHENHYDRAMINE HYDROCHLORIDE | AAA Pharmaceutical, Inc. | 76724432-ff3c-404f-ba1f-5af68e3ab8c4 | 2024-12-02 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | AAA Pharmaceutical, Inc. | 73d4fc82-8508-44f8-83ca-9f32c5cd847b | 2024-12-02 | 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 |