Sleep Aid
- Product NDC
- 51316-367
- 11-digit product format
- 513160367
- Labeler code
- 51316
- Product ID
- 51316-367_c98e1f9f-5f74-443d-a11b-1d2b2da9dd75
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-07-09
- 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
- Sleep Aid
- Brand name suffix
- Nighttime
- 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 |
|---|---|
| 1049630 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fe58ce40-ae88-4dc5-9486-e67041f6d852 | 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 |
|---|---|---|---|---|---|---|
| 51316-367-12 | Sleep AidNighttime | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | 4 | |
| 51316-367-12 | Sleep AidNighttime | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 4 |
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 |
|---|---|---|---|---|---|---|
| equate NIGHTTIME Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | WALMART INC. | 3d3f2e0c-e141-d49f-e063-6394a90ad0e6 | 2025-10-21 | Warnings | M010 |
| LEADER Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | CARDINAL HEALTH | 6fe34d05-84a4-4254-aea6-77b52122ea18 | 2025-10-14 | Warnings | M010 |
| LEADER Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | CARDINAL HEALTH | 68c79c47-11bf-4b51-ace0-723cac7a4620 | 2025-10-14 | Warnings | M010 |
| InstaRelief Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | DXM Pharmacuetical, Inc. | e0459e71-32dd-4715-b103-bb14db42c5f3 | 2025-10-06 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Family Dollar (FAMILY WELLNESS) | 1eb2e4d7-1572-4c0c-888b-342831298cad | 2025-10-03 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | 20b8b9a7-cd04-4e8f-b26e-2d01a0871802 | 2025-09-29 | Warnings | M010 |
| AXIV - VroZzz | DIPHENHYDRAMINE HYDROCHLORIDE | Vivunt Pharma LLC | 131a60cf-02ec-5a5b-e063-6294a90abd1f | 2025-09-17 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 485ce8ae-c2b7-462f-9c08-8594cd121f0c | 2025-09-11 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREENS | 35b78063-e717-2ccb-e063-6394a90a18eb | 2025-09-04 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | TARGET Corporation | ded84160-8f6a-4ad1-93be-efbf3a6c3b8f | 2025-09-03 | Warnings | M010 |
| QUALITY CHOICE NIGHTTIME SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 3ce00c99-1a9b-41f1-a99a-35e03730dff0 | 2025-08-23 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | BJWC (Berkley & Jensen / BJ's) | 2f476647-5727-3443-e063-6394a90afd3f | 2025-08-19 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | BJWC (Berkley & Jensen / BJ's) | 2f477706-0ce2-97b0-e063-6294a90a5c8e | 2025-08-19 | Warnings | M010 |
| Nighttime Sleep Aid | NIGHTTIME SLEEP AID | Allegiant Health | 407ff0ee-41a3-4dea-95c8-556f664e115e | 2025-08-06 | Warnings | M010 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | H E B | 1069961c-ed3b-471f-a632-81024c37dbd9 | 2025-08-04 | Warnings | M010 |
| TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Topco Associates LLC | 2ea0b2cf-f055-11f6-e063-6394a90a5364 | 2025-08-01 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | Good Sense (Geiss, Destin & Dunn, Inc.) | 135482d0-5264-4c81-b43b-8fc931bb02e8 | 2025-07-30 | Warnings | M010 |
| dg health sleep aid | DIPHENHYDRAMINE HCL | Dolgencorp, LLC | 4c266acb-49ae-4d04-8602-0df35b22874a | 2025-07-10 | Warnings | M010 |
| NIGHT TIME SLEEP-AID | DIPHENHYDRAMINE HCL | Advanced Rx LLC | 07c69e63-deb1-4607-9f7f-1cf0cd05cc82 | 2025-07-02 | Warnings | M010 |
| Rest Simply | DIPHENHYDRAMINE HYDROCHLORIDE | DISCOUNT DRUG MART | 896ae7b8-cb8d-1aaa-e053-2a95a90a4e1a | 2025-06-30 | Warnings | M010 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | fe58ce40-ae88-4dc5-9486-e67041f6d852 | 4 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | fe58ce40-ae88-4dc5-9486-e67041f6d852 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 51316-367-12 | 51316036712 | 1 BOTTLE, PLASTIC in 1 CARTON (51316-367-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2025-07-09 | No | No | Current |