AGRIFEN
- Product NDC
- 69729-802
- 11-digit product format
- 697290802
- Labeler code
- 69729
- Product ID
- 69729-802_5ca4675d-7cf1-fc94-e063-6394a90a194e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextomethorphan Hydrobromide, Phenylephrine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-03-31
- 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
- AGRIFEN
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-802-10 | AGRIFEN | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 1 | |
| 69729-802-10 | AGRIFEN | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 1 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | ff433512-55b7-4fc9-8a55-aff5cbb749ef | 2024-10-11 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 3170354a-4752-49a0-97ed-3d9db266a059 | 2024-10-11 | Warnings | M012 |
| Tukol Children Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | 235a6d2b-7302-410c-be35-4d5ff7bbdfce | 2024-10-11 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS Pharmacy | 6c7b0ea6-bff9-4fd2-9e00-64015c326ee8 | 2024-10-11 | Warnings | M012 |
| nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Meijer Distribution Inc | dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b | 2024-10-11 | Warnings | M012 |
| Signature Care Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | 838d2f11-2ee4-4081-98c8-b87e79aa47c4 | 2024-10-11 | Warnings | M012 |
| Menthol | COUGH SUPPRESSANT | McKesson | 9d4def70-480f-f2fa-e053-2995a90a9877 | 2024-10-10 | Warnings | M012 |
| Menthol | COUGH SUPPRESSANT | McKesson | 9d5b4ef6-4eb8-41f6-e053-2a95a90a1350 | 2024-10-10 | Warnings | M012 |
| Tukol Sugar Free Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Genomma Lab USA | 95e0a3eb-5a58-4c8b-a70b-fb0cca1e0841 | 2024-10-08 | Warnings | M012 |
| Rompe Pecho CF CF | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Efficient Laboratories Inc | 06e96e0c-f21f-e706-e063-6294a90a0780 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | f9f0d020-e031-245e-e053-6294a90addb5 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7ee463-8003-a306-e053-6294a90a8259 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7e4a84-d2c2-65e5-e053-6394a90a0c72 | 2024-10-08 | Warnings | M012 |
| Cough Drops | CHERRY | United Natural Foods, Inc. | f9f0e853-6997-a49b-e053-6294a90aa4b8 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7fa728-911d-aaf0-e053-6394a90ace31 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7f3b84-1e61-eadf-e053-6394a90a9e5c | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7f515f-7302-d153-e053-6394a90a0834 | 2024-10-08 | Warnings | M012 |
| Rompe Pecho NT NT | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Efficient Laboratories Inc | 06faafaa-50a6-c16e-e063-6294a90a49cb | 2024-10-08 | Warnings | M012 |
| Mucus Relief Cough and Congestion DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Bryant Ranch Prepack | 8c25285e-e2cd-4e10-af63-5dce8098b615 | 2024-10-08 | Warnings | M012 |
| Severe Throat Sore Drops | MENTHOL | Target Corporation Inc. | 949543d5-5043-ac06-e053-2995a90ab398 | 2024-10-07 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 31aaa8e7-7980-1e00-e063-6294a90a18d0 | 1 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 31aaa8e7-7980-1e00-e063-6294a90a18d0 | 1 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 31aaa8e7-7980-1e00-e063-6294a90a18d0 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69729-802-10 | 69729080210 | 1 BLISTER PACK in 1 CARTON (69729-802-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2025-03-31 | No | No | Current |