Sleep-EZ Nighttime Sleep Aid is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Safrel Pharmaceuticals, Llc.. The primary component is Diphenhydramine Hydrochloride.
| Product ID | 71309-110_87537c22-0822-2394-e053-2a95a90aa1d0 |
| NDC | 71309-110 |
| Product Type | Human Otc Drug |
| Proprietary Name | Sleep-EZ Nighttime Sleep Aid |
| Generic Name | Diphenhydramine Hcl 25 Mg |
| Dosage Form | Tablet, Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-06-01 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Labeler Name | Safrel Pharmaceuticals, LLC. |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Active Ingredient Strength | 25 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2017-06-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-06-01 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-06-01 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-06-01 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-06-01 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-06-01 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-06-01 |
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
| SPL SET ID: | 87537ba2-f4d7-8ea3-e053-2a95a90acc38 |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 71309-110 | Sleep-EZ Nighttime Sleep Aid | Diphenhydramine HCl 25 mg |
| 29485-9285 | Allergy Relief | Diphenhydramine HCl 25 mg |
| 72090-021 | Allergy Relief | Diphenhydramine HCl 25 mg |
| 50066-247 | Dalay | Diphenhydramine HCl 25 mg |
| 69517-110 | Nighttime Sleep Aid | Diphenhydramine HCl 25 mg |
| 71679-084 | Nighttime Sleep Aid | Diphenhydramine HCl 25 mg |
| 71679-110 | Nighttime Sleep Aid | Diphenhydramine HCl 25 mg |
| 21130-004 | Nighttime Sleep-Aid | Diphenhydramine HCl 25 mg |
| 69168-263 | Sleep Aid | Diphenhydramine HCl 25 mg |
| 72090-020 | Sleep Aid | Diphenhydramine HCl 25 mg |
| 73057-358 | Sleep Aid | Diphenhydramine HCl 25 mg |
| 69168-910 | Sound Body Sleep Aid | Diphenhydramine HCl 25 mg |