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 |
|---|---|---|---|---|---|---|
| Sleep Aid Nighttime | DIPHENHYDRAMINE HCL | CVS Pharmacy | db951d14-ba8b-4d56-8264-2b8ce84a854c | 2024-03-07 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | e0da439f-7e23-4e60-8d16-b607aa41ed17 | 2024-02-28 | Warnings | M010 |
| Nighttime sleep aid Maximum Strength | DIPHENHYDRAMINE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | 40e73317-5126-4961-8f28-60899ffbec5a | 2024-02-20 | Warnings | M010 |
| Nighttime sleep aid Maximum Strength | DIPHENHYDRAMINE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | 2424fb95-06e2-49e7-aea0-7797a37aef4d | 2024-02-20 | Warnings | M010 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy, Inc | f5b609e1-e63b-2e3b-e053-2995a90a76b9 | 2024-02-12 | Warnings | M010 |
| Kroger Nighttime Sleep Aid CAPLET | DIPHENHYDRAMINE HYDROCHLORIDE | The Kroger Co. | f0f3f58d-9457-4697-98e6-ef52d350cf67 | 2024-01-29 | Warnings | M010 |
| Nighttime Sleep Aid | NIGHTTIME SLEEP AID | Allegiant Health | 88feea1d-c961-45e9-b9a6-1418b970aaba | 2024-01-16 | Warnings | M010 |
| Sleep-Aid Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 110, LLC. DBA Leader | 4283558d-62df-4297-bc85-a4e06681a920 | 2024-01-11 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | DeMoulas Market Basket | d3f35102-94ed-4da0-9c29-312e5468fa05 | 2023-12-29 | Warnings | M010 |
| nighttime sleep-aid | DIPHENHYDRAMINE HCL | Bionpharma Inc. | c0074c77-287e-6c26-e053-2995a90a4d31 | 2023-12-26 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYRAMINE HYDROCHLORIDE | TARGET CORPORATION | fac83dad-f6fd-3316-e053-6394a90a99aa | 2023-12-21 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENYDRAMINE HYDROCHLORIDE | TARGET CORPORATION | fc7ed67f-bac9-f9ed-e053-6294a90ad9a1 | 2023-12-16 | Warnings | M010 |
| Jet-Asleep Double Strength Night Time Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Bell Pharmaceuticals, Inc. | d053201d-9ae2-47c2-8f07-3e4b4af940b6 | 2023-12-15 | Warnings | M010 |
| Sleep-Aid, Circle K | DIPHENHYDRAMINE HCL CAPLET, 25MG | Lil' Drug Store Products, Inc. | d3ad24c4-44ba-6451-e053-2a95a90a1339 | 2023-12-14 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | VALU MERCHANDISERS COMPANY | fed2f7ae-2829-f967-e053-6294a90adc0a | 2023-10-12 | Warnings | M010 |
| Sleep Aid | SLEEP AID | Better Living Brands LLC | 2b730fa5-47f9-468d-86ed-0d49d9cd8dc4 | 2023-07-06 | Warnings | M010 |
| Diphenhydramine HCl 25mg | SLEEP AID | Allegiant Health | 2890e4ba-d642-437d-8a86-24996a74e027 | 2021-11-23 | Warnings | M010 |
| Sleep Aid | SLEEP AID | Allegiant Health | 9a0b347e-5719-42f3-9050-df5165495e88 | 2021-10-14 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Allegiant Health | ec57db48-0f3a-4b12-8633-b45a4366c269 | 2020-11-06 | Warnings | M010 |
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 |