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 |
|---|---|---|---|---|---|---|
| NITETIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 0e65c5d1-a18b-452c-9be6-8d44d34577e9 | 2026-07-08 | Warnings | M012 |
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | Cardinal Health 110, LLC. DBA Leader | aaecfda5-1a50-4d8a-9909-7153c1a22bda | 2026-07-08 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 7cb9f378-5d64-475f-bf26-4058ba6c15b4 | 2026-07-08 | Warnings | M012 |
| DG HEALTH DAY TIME INTENSE FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Dolgencorp Inc | f174d08e-3335-4cc9-8766-4070f18c4f31 | 2026-07-08 | Warnings | M012 |
| Mucus Relief | GUAIFENESIN 400 MG | Health Pharma USA LLC | d60a3e9d-e88e-3b19-e053-2995a90a3e8d | 2026-07-07 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Health Pharma USA LLC | d38f47ea-7fda-170b-e053-2995a90adc82 | 2026-07-07 | Warnings | M012 |
| Guaifenesin 200mg | GUAIFENESIN | Health Pharma USA LLC | d68222f7-b796-7b27-e053-2995a90a2efe | 2026-07-07 | Warnings | M012 |
| Vicks Sinex Severe PAIN, MUCUS and CHEST CONGESTION | ACETAMINOPHEN, GUAIFENESIN | The Procter & Gamble Manufacturing Company | 5605aab6-6074-0a3b-e063-6294a90a49a2 | 2026-07-07 | Warnings | M012 |
| Cold and Flu Severe Day Time / Night Time | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | DOLGENCORP, LLC | acdcc6ce-c190-4de6-b126-62fe9043112e | 2026-07-07 | Warnings | M012 |
| Calmco Allergy Relief | DIPHENHYDRAMINE HCL | CalmCo LLC | 471b1a43-1708-8be7-e063-6394a90a9bb7 | 2026-07-06 | Warnings | M012 |
| Dr Kids Pain and Fever | ACETAMINOPHEN | CalmCo LLC | 2ee6df99-727a-34c6-e063-6294a90a6bbc | 2026-07-06 | Warnings | M012 |
| Dr Kids Allergy Relief | DIPHENHYDRAMINE HCL | CalmCo LLC | 28ec213e-fabb-28ec-e063-6394a90ad102 | 2026-07-06 | Warnings | M012 |
| AGRIFEN | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | OPMX LLC | 55fa7b02-6613-1049-e063-6294a90a1def | 2026-07-06 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Select Consumer Group | 55fc7d6f-cc44-b4c0-e063-6294a90ae4fc | 2026-07-06 | Warnings | M012 |
| Allergy Plus Sinus Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL | DOLGENCORP, LLC | f2eacb1b-8b29-41ec-828a-c1f902ac0934 | 2026-07-06 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Select Consumer Group | 55d10292-e673-9896-e063-6294a90a5674 | 2026-07-04 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Select Consumer Group | 55bddbea-5ad9-6a18-e063-6394a90a461d | 2026-07-03 | Warnings | M012 |
| CONTAC COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | VESPYR BRANDS LLC | f72d510b-e370-4137-8d4f-d9afd5d19a19 | 2026-07-03 | Warnings | M012 |
| Vicks NyQuil Severe Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | 6eef8a59-2f8a-1a90-e053-2a91aa0a1d52 | 2026-07-02 | Warnings | M012 |
| Nite time Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | f8f84be1-e3b1-4e93-8e1c-ee93e1f4af13 | 2026-07-02 | 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 |