Acetaminophen Diphenhydramine HCl is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Granules Usa, Inc.. The primary component is Diphenhydramine Hydrochloride; Acetaminophen.
| Product ID | 69848-014_8c9f68e3-fedd-6457-e053-2995a90a045a |
| NDC | 69848-014 |
| Product Type | Human Otc Drug |
| Proprietary Name | Acetaminophen Diphenhydramine HCl |
| Generic Name | Acetaminophen Diphenhydramine Hcl |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-07-01 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Labeler Name | Granules USA, Inc. |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN |
| Active Ingredient Strength | 25 mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2019-07-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph not final |
| Application Number | part343 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2019-07-01 |
| Marketing Category | OTC monograph not final |
| Application Number | part343 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2019-07-01 |
| Marketing Category | OTC monograph not final |
| Application Number | part343 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2019-07-01 |
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
| SPL SET ID: | 8c9f68e3-fedc-6457-e053-2995a90a045a |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0363-9664 | Acetaminophen Diphenhydramine HCL | Acetaminophen Diphenhydramine HCL |
| 0363-9991 | Acetaminophen Diphenhydramine HCl | Acetaminophen Diphenhydramine HCl |
| 21130-354 | Acetaminophen Diphenhydramine HCl | Acetaminophen Diphenhydramine HCl |
| 55315-988 | Acetaminophen Diphenhydramine HCl | Acetaminophen Diphenhydramine HCl |
| 55315-990 | Acetaminophen Diphenhydramine HCl | Acetaminophen Diphenhydramine HCl |
| 68016-651 | Acetaminophen Diphenhydramine HCl | Acetaminophen Diphenhydramine HCl |
| 68016-654 | Acetaminophen Diphenhydramine HCl | Acetaminophen Diphenhydramine HCl |
| 68016-659 | Acetaminophen Diphenhydramine HCl | Acetaminophen Diphenhydramine HCl |
| 69842-306 | Acetaminophen Diphenhydramine HCl | Acetaminophen Diphenhydramine HCl |
| 69842-308 | Acetaminophen Diphenhydramine HCl | Acetaminophen Diphenhydramine HCl |
| 69848-014 | Acetaminophen Diphenhydramine HCl | Acetaminophen Diphenhydramine HCl |
| 59726-863 | Pain Reliever PM | Acetaminophen Diphenhydramine HCL |
| 59726-868 | Pain Reliever PM | Acetaminophen Diphenhydramine HCL |