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 |
|---|---|---|---|---|---|---|
| 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 |
| daytime cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | df31056b-d0eb-4094-98d9-3d444210d50d | 2025-01-16 | Warnings | M012 |
| Childrens Ibuprofen Oral Suspension | IBUPROFEN | Reliable 1 Laboratories LLC | 28dd9baa-43bd-b60a-e063-6394a90a8cf7 | 2025-01-15 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Reliable 1 Laboratories LLC | ae469d4f-91c4-cff0-e053-2995a90a0497 | 2025-01-15 | Warnings | M012 |
| Diphenhydramine HCL 25 mg | DIPHENHYDRAMINE HCL | Reliable 1 Laboratories LLC | 32f58cb3-941f-263b-e054-00144ff8d46c | 2025-01-15 | Warnings | M012 |
| Diphenhydramine HCl 25 mg | DIPHENHYDRAMINE HCL | Reliable 1 Laboratories LLC | 32fa40ad-fed5-586f-e054-00144ff88e88 | 2025-01-15 | Warnings | M012 |
| CVS Health Chest Congestion and Cough HBP SOFTGEL | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS Pharmacy, Inc | 2741ba44-1cc7-1812-e063-6394a90a8faa | 2025-01-14 | Warnings | M012 |
| DAY COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORPORATION | 2b941963-8a8c-4148-e063-6294a90a1dfb | 2025-01-13 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | SDA Laboratories, Inc. | 437e6a13-a4ff-4f98-8973-042f224ee85e | 2025-01-13 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | SDA Laboratories, Inc. | 6a520986-1004-4ee6-9a47-1dfd90bb1b2c | 2025-01-13 | Warnings | M012 |
| good sense daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L. Perrigo Company | 5ddf3283-94e4-465d-842a-471ee946c330 | 2025-01-10 | Warnings | M012 |
| Vicks VapoSteam | CAMPHOR (SYNTHETIC) | Kaz USA, Inc | c28da455-07ad-4053-8b9e-fc559f9a3f72 | 2025-01-10 | Warnings | M012 |
| Guaifenesin 200mg | GUAIFENESIN | Aphena Pharma Solutions - Tennessee, LLC | 45ac210a-8c54-4469-8e10-e6fe52b89cb5 | 2025-01-09 | 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 |