Nighttime Sleep Aid
- Product NDC
- 68391-613
- 11-digit product format
- 683910613
- Labeler code
- 68391
- Product ID
- 68391-613_3c10ec86-2536-00f5-e063-6394a90a244c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- BJWC (Berkley & Jensen / BJ's)
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-08-20
- 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
- Nighttime Sleep Aid
- 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 |
|---|---|
| 2f476647-5727-3443-e063-6394a90afd3f | 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 |
|---|---|---|---|---|---|---|
| 68391-613-92 | Nighttime Sleep Aid | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 2 | |
| 68391-613-92 | Nighttime Sleep Aid | 16 in 1 CARTON | CAPSULE, LIQUID FILLED | 16 | 2 |
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 |
|---|---|---|---|---|---|---|
| RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 2d64f5c2-dfa9-e5f5-e063-6294a90a0711 | 2025-03-19 | Warnings | M010 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | Harris Teeter, LLC | 322a71bb-fc68-4a03-8a24-20cbdbe6d91b | 2025-03-13 | Warnings | M010 |
| REVASOL SLEEP AID | DIPHENHYDRAMINE HCL | Rnv LLC | 30131010-be70-c940-e063-6394a90a190a | 2025-03-11 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | 1a7189ba-2d52-44fc-83a4-b9f6156c62ff | 2025-03-07 | Warnings | M010 |
| meijer NIGHTTIME Sleep Aid SOFTGEL | DIPHENHYDRAMINE HYDROCHLORIDE | Meijer, Inc. | 1bede4cd-bf55-8b84-e063-6394a90aa5c9 | 2025-02-19 | Warnings | M010 |
| PHARBEDRYL | DIPHENHYDRAMINE HCL 50MG | Ulai Health LLC | 135293fb-5674-4638-be55-b968cf51257e | 2025-01-20 | Warnings | M010 |
| Allergy Relief 25 mg | DIPHENHYDRAMINE HCL 25MG | Ulai Health LLC | 751f13d4-c4d6-47a5-b40d-1563de08c048 | 2025-01-12 | Warnings | M010 |
| RoboCough | DEXTROMETHORPHAN HBR | DXM Pharmacuetical, Inc. | 32fa7a09-8624-44c1-b9e4-8a8f0594292b | 2025-01-10 | Warnings | M010 |
| SleepAid (Diphenhydramine HCL) | DIPHENHYDRAMINE HCL | APNAR PHARMA LP | faaf5d51-d81d-3acc-e053-6294a90ae08f | 2025-01-09 | Warnings | M010 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 971515fa-b4d2-1197-e053-2995a90a838d | 2025-01-03 | Warnings | M010 |
| Nighttime Sleep-Aid Softgel | DIPHENHYDRAMINE HYDROCHLORIDE | CVS PHARMACY, INC | 8b0fa259-6702-4667-bac6-f7d0b0839ae0 | 2025-01-01 | Warnings | M010 |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | 9f1c078d-e537-4ec0-8ae9-54c98282be29 | 2024-12-31 | Warnings | M010 |
| Discount Drugmart Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | Discount Drug Mart, Inc | d6d77c2e-42b3-48f0-a662-3872155ef34d | 2024-12-18 | Warnings | M010 |
| Kroger Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | THE KROGER CO | 98437a72-1b98-4301-b92f-0c17b305cf59 | 2024-12-18 | Warnings | M010 |
| equate nighttime sleep aid | DIPHENHYDRAMINE HYDROCHLORIDE | WALMART INC. | 6e162152-b414-470c-b146-649d99870577 | 2024-12-17 | Warnings | M010 |
| Quality Choice Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | e8b2858b-a737-c500-e053-2995a90adba6 | 2024-12-16 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | f99cc210-b946-42a2-9164-8aa5308c5418 | 2024-12-11 | Warnings | M010 |
| CalmCo Sleep Aid Gummy Bite | DIPHENHYDRAMINE HCL | CalmCo LLC | 0c534cbd-40e6-8af0-e063-6394a90a5605 | 2024-12-07 | Warnings | M010 |
| Somnapure Clinical Strength | DIPHENHYDRAMINE HYDROCHLORIDE | Force Factor Brands LLC | 063517c0-bcb1-46dd-85f1-bbb2f24274ef | 2024-12-06 | Warnings | M010 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | AAA Pharmaceutical, Inc. | c280cf02-ebb2-4847-a66d-d02aff3ea0c9 | 2024-12-02 | Warnings | M010 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | 2f476647-5727-3443-e063-6394a90afd3f | 2 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | 2f476647-5727-3443-e063-6394a90afd3f | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68391-613-92 | 68391061392 | 16 BLISTER PACK in 1 CARTON (68391-613-92) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 16 blister pack | 2025-08-20 | No | No | Current |