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 |
|---|---|---|---|---|---|---|
| Cold and Flu Nighttime Severe, 24-7 Life | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Lil' Drug Store products, Inc. | 05d0410f-164e-e7ee-e063-6394a90a2aaa | 2024-12-16 | Warnings | M012 |
| tussin dm max daytime nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN | CVS Pharmacy | 6feaf29e-de06-4c94-912c-a76ea2cbd8c1 | 2024-12-16 | Warnings | M012 |
| Leader Childrens Multi Symptom Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER | 169ff9cf-fcf5-46a6-b460-259421f2ec07 | 2024-12-16 | Warnings | M012 |
| Childrens Mucus and Cough Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | CARDINAL HEALTH 110, LLC. DBA LEADER | 125eeb3d-0ee2-45bb-81c0-4ca699979886 | 2024-12-16 | Warnings | M012 |
| Dextromethorphan HBr 15 mg Liquid Gels | DEXTROMETHORPHAN HBR | RUGBY LABORATORIES | cf3cc387-6642-43fd-999d-688fdaf65d4f | 2024-12-14 | Warnings | M012 |
| Allergy Relief Dye-Free Softgel | DIPHENHYDRAMINE HYDROCHLORIDE | CVS PHARMACY, INC | 60b1bb79-3ed1-438b-a27f-f7fbc108d114 | 2024-12-14 | Warnings | M012 |
| Rycontuss Cherry Flavor | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Okendpharma, Inc. | c91798fa-48ab-47a0-92da-4d44c2aafde0 | 2024-12-13 | Warnings | M012 |
| Mentholatum Lavender Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Mentholatum Company | 6f208c05-617d-492a-a016-e9d6be3c971f | 2024-12-13 | Warnings | M012 |
| CVS Vapor Steam | CAMPHOR (SYNTHETIC) | CVS | 49da2c40-afc5-5770-e054-00144ff88e88 | 2024-12-13 | Warnings | M012 |
| Kroger Daytime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | The Kroger Company | e428dd83-c538-2a92-e053-2a95a90a0e16 | 2024-12-13 | Warnings | M012 |
| Kroger Nighttime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | The Kroger Company | e46291c7-6f4d-46a2-e053-2a95a90a80a1 | 2024-12-13 | Warnings | M012 |
| Foster and Thrive Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | 7eaba464-5cdb-4bd4-b272-38fa108658d5 | 2024-12-13 | Warnings | M012 |
| SUDAFED OM Sinus Severe Original | OXYMETAZOLINE HYDROCHLORIDE | Kenvue Brands LLC | 1d089074-3969-ce6e-e063-6294a90aa70c | 2024-12-12 | Warnings | M012 |
| RIGHT REMEDIES Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc | b4fc014c-7c5f-46a4-bf13-57103b6fa018 | 2024-12-11 | Warnings | M012 |
| Diphenhydramine Hydrochloride 25mg | DIPHENHYDRAMINE HYDROCHLORIDE 25MG | Strive Pharmaceuticals Inc | b440eb2e-4de9-2b65-e053-2995a90abda8 | 2024-12-11 | Warnings | M012 |
| Meijer Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Meijer Distribution Inc. | 6933ca9d-a32d-d856-e053-2a91aa0a408e | 2024-12-10 | Warnings | M012 |
| Effervescent Orange Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Meijer Distribution Inc. | 826b5c0d-7a75-bbf0-e053-2a91aa0aebd6 | 2024-12-10 | Warnings | M012 |
| DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC | MENTHOL | Ricola USA Inc. | 09141018-37ba-4c93-9051-1ed129c448c1 | 2024-12-10 | Warnings | M012 |
| Original Herb Cough Drops | MENTHOL | Ricola USA Inc. | 6ac9d95b-f6b9-4515-b126-697f8f839612 | 2024-12-10 | Warnings | M012 |
| THE ORIGINAL NATURAL HERB COUGH DROPS | MENTHOL | Ricola USA Inc. | 989d1529-2875-47bf-81df-65494d62be7a | 2024-12-10 | 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 |