Viro-Flu AM
- Product NDC
- 69729-831
- 11-digit product format
- 697290831
- Labeler code
- 69729
- Product ID
- 69729-831_5d1fb591-f73f-dfe4-e063-6294a90abd88
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-06-25
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 325; 5; 10 mg/1; mg/1; mg/1
- 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
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
- Viro-Flu AM
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | AAA PHARMACEUTICAL, INC. | 19898135-0f7b-45a5-a672-14c49fd21077 | 2024-12-02 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | bb72de5d-d3c0-42fc-ae52-a3ad95214af5 | 2024-12-02 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AAA Pharmaceutical, Inc. | a242e005-0330-4afb-83b8-13c7d56f5c6d | 2024-12-02 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | TopCo Associates LLC | 53b15e75-9efd-4b4b-834b-6e9f12c60108 | 2024-12-02 | Warnings | M012 |
| Geri-Dryl allergy relief | DIPHENHYDRAMINE HCL | Geri-Care Pharmaceutical Corp | ac8a14ac-7023-1e23-e053-2995a90aea3a | 2024-11-28 | Warnings | M012 |
| Childrens Benadryl DYE-FREE ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 10d478ff-ddc6-45da-87ff-cfe1b2b07a8e | 2024-11-27 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | 9cd10af6-a2fa-44f8-8df3-a6d2a95a5293 | 2024-11-27 | Warnings | M012 |
| Severe Sinus Congestion Allergy and Cough Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | PuraCap Pharmaceutical LLC | 36a4ec1f-50c3-4d61-ada9-987ccad3563c | 2024-11-26 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69729-831-02 | 69729083102 | 2 CAPSULE, LIQUID FILLED in 1 POUCH (69729-831-02) | 2026-06-25 | No | No | Current | |
| 69729-831-50 | 69729083150 | 25 POUCH in 1 CARTON (69729-831-50) / 2 CAPSULE, LIQUID FILLED in 1 POUCH | 25 pouch | 2026-06-25 | No | No | Current |