EZ Nite Sleep
- Product NDC
- 41226-613
- 11-digit product format
- 412260613
- Labeler code
- 41226
- Product ID
- 41226-613_16443f3d-c881-1fe3-e063-6394a90a4e4d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhyramine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- KROGER COMPANY
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-15
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- EZ Nite Sleep
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049909 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0fec16a4-b4eb-8f8f-e063-6394a90a7327 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41226-613-24 | EZ Nite Sleep | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 2 | |
| 41226-613-24 | EZ Nite Sleep | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 2 |
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 |
|---|---|---|---|---|---|---|
| Equaline Night Time Sleep Aid | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 6d34ee3e-3d61-481e-98d6-acfa066e4247 | 2024-10-16 | Warnings | M010 |
| basic care nighttime sleep aid | DIPHENHYDRAMINE HCL | Amazon.com Services LLC | 027de5ea-5c07-4960-8a98-8cf2c0e54a92 | 2024-10-16 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | H E B | d5189048-5eed-4ec4-8c4a-4a167728c4e7 | 2024-10-16 | Warnings | M010 |
| berkley and jensen sleep aid | DIPHENHYDRAMINE HCL | BJWC | e31917a1-e72d-4f71-893f-43046169a32d | 2024-10-16 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | 5fab9bd4-66d7-4356-a778-8900b2e270e2 | 2024-10-11 | Warnings | M010 |
| Sleep Aid NightTime | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 5b005bfc-f588-4abc-8bb1-4691b40448cd | 2024-10-07 | Warnings | M010 |
| Sominex | DIPHENHYDRAMINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | f70ce1a6-c334-025e-e053-6294a90ae53f | 2024-10-03 | Warnings | M010 |
| meijer NIGHTTIME Sleep Aid CAPLET | DIPHENHYDRAMINE HYDROCHLORIDE | Meijer, Inc. | 1c2b57b3-92cb-256b-e063-6394a90ad41b | 2024-09-09 | Warnings | M010 |
| Up and Up Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Target Corporation | 0ab5a374-d565-4385-bee3-538a8f09b19e | 2024-08-15 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 8d985ad7-71b9-493f-9b9a-d6ef280f72dd | 2024-08-12 | Warnings | M010 |
| Rest Simply | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 3618eb73-6929-4ca5-833d-265b006f15f9 | 2024-08-12 | Warnings | M010 |
| careone nighttime sleep aid | DIPHENHYDRAMINE HYDROCHLORIDE | American Sales Company | 14803f99-52c7-4324-b64c-971906144739 | 2024-07-17 | Warnings | M010 |
| Betr sleep aid | DIPHENHYDRAMINE HYDROCHLORIDE | Live Betr LLC | 8c2d5514-62c1-4e98-8412-20534365b934 | 2024-07-17 | Warnings | M010 |
| topcare sleep aid nighttime | DIPHENHYDRAMINE HYDROCHLORIDE | Topco Associates LLC | 30284271-0411-4abf-bc62-d956dc794432 | 2024-07-17 | Warnings | M010 |
| dg health sleep aid | DIPHENHYDRAMINE HYDROCHLORIDE | Dolgencorp Inc | 038c1b4e-43f5-4370-896b-97da1b0a89ca | 2024-07-17 | Warnings | M010 |
| good sense nighttime sleep aid | DIPHENHYDRAMINE HYDROCHLORIDE | L. Perrigo Company | ba2adc30-0301-4d53-bce6-fc8b7e34b076 | 2024-07-10 | Warnings | M010 |
| Sleep Aid | SLEEP AID | Good Sense | c1481fad-9b32-4f84-8f03-4b4fa5edc866 | 2024-06-18 | Warnings | M010 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 29b49616-ee5a-4574-81f1-0052addb8f66 | 2024-04-22 | Warnings | M010 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | b8757d18-6c7d-45de-925a-e2814625f749 | 2024-04-22 | Warnings | M010 |
| EZ Nite Sleep | DIPHENHYRAMINE HYDROCHLORIDE | KROGER COMPANY | 0fec16a4-b4eb-8f8f-e063-6394a90a7327 | 2024-04-17 | Warnings | M010 41226-613 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | 0fec16a4-b4eb-8f8f-e063-6394a90a7327 | 2 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | 0fec16a4-b4eb-8f8f-e063-6394a90a7327 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 41226-613-24 | 41226061324 | 2 BLISTER PACK in 1 CARTON (41226-613-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2024-04-15 | No | No | Current |