AGRIFEN
- Product NDC
- 69729-816
- 11-digit product format
- 697290816
- Labeler code
- 69729
- Product ID
- 69729-816_5d1fc2d4-a721-e938-e063-6294a90a8447
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-07-08
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 325; 10 mg/1; mg/1
- Pharmacologic classes
- Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- 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 |
| 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 |
|---|---|---|---|---|---|---|
| Cold Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter | c92b508b-e5f9-4149-8c4b-d21845943b3b | 2024-10-22 | Warnings | M012 |
| Cold Flu Severe Day Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter | 2924a691-b352-4263-b6ba-9ab97e95e2a5 | 2024-10-22 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HARRIS TEETER | b2091281-a64a-190a-e053-2995a90a890a | 2024-10-22 | Warnings | M012 |
| tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | Safeway | cf04bdf7-fed4-4f06-a193-f2e83fcc531c | 2024-10-22 | Warnings | M012 |
| Tukol Honey Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | c9572b16-8e28-4f98-bd87-8a07721a49c6 | 2024-10-21 | Warnings | M012 |
| Tukol Honey Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Genomma Lab USA | bf25f38e-3549-4f78-be90-46605b5f2c11 | 2024-10-21 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | HEB | b5a6719e-746b-58ec-e053-2a95a90af010 | 2024-10-21 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | a6cdc084-c23b-e733-e053-2995a90a3506 | 2024-10-21 | Warnings | M012 |
| Cold Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | ea39a67d-8a99-4f7c-9925-94b07d0b1092 | 2024-10-21 | Warnings | M012 |
| Head Congestion plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | eb7920a3-3c25-6aa1-e053-2995a90ac2b9 | 2024-10-21 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | 9cbb3ab1-5f32-421e-9f28-d99be9447e9f | 2024-10-21 | Warnings | M012 |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | eb791902-e2c3-5662-e053-2995a90a37fd | 2024-10-21 | Warnings | M012 |
| Cold Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | c3849b66-697f-4f6e-93ab-76de031b3c70 | 2024-10-21 | Warnings | M012 |
| Cold Flu Severe Day Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | ee1477ed-00c4-46ea-bc57-aef214076dc2 | 2024-10-21 | Warnings | M012 |
| DAYTIME SEVERE COLD AND FLU MAXIMUM STRENGTH | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | 774e8bee-1ab5-4587-82e4-31da8ec83544 | 2024-10-21 | Warnings | M012 |
| Mucus Relief Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | b1ba8ade-3441-f243-e053-2995a90a1230 | 2024-10-21 | Warnings | M012 |
| Mucus Relief Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | b1ba22ac-c38d-a42e-e053-2995a90a6900 | 2024-10-21 | Warnings | M012 |
| Diphenhydramine HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 25034563-6422-daf6-e063-6394a90af980 | 2024-10-21 | Warnings | M012 |
| Childrens Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER | 198add5f-20b7-75b0-e063-6394a90a6bd4 | 2024-10-21 | Warnings | M012 |
| Tukol Honey Children Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | dae33df8-2294-4242-a25b-2d89d1f63b23 | 2024-10-18 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69729-816-10 | 69729081610 | 1 BLISTER PACK in 1 CARTON (69729-816-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2026-07-08 | No | No | Current |