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 |
|---|---|---|---|---|---|---|
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 6c9b7576-428a-4884-8331-bb312c9046bd | 2026-04-01 | Warnings | M010 |
| Calmco Sleep Aid | DIPHENHYDRAMINE HCL | CalmCo LLC | 471d4c70-813a-19de-e063-6394a90aeb25 | 2026-03-31 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | The Kroger Co. | 0db543bb-c6c3-4370-a70c-e1652781fd7d | 2026-03-25 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL 50MG | Grocery Outlet | 57a751e9-d8b6-4527-8537-bc4be718f5ec | 2026-03-17 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Walgreen Company | df7a43d1-83a7-4e86-baef-4b9d1ebf0dbb | 2026-03-16 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Grocery Outlet, Inc. | 4454df6a-931f-3f03-e063-6294a90afe73 | 2026-03-14 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Cardinal Health 110, LLC. DBA Leader | 1d73e966-aa4a-40a0-b42a-fda8e500756e | 2026-03-13 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Walgreens | ea1b5ec1-3c8e-437d-8e37-f38ab66d9f78 | 2026-03-13 | Warnings | M010 |
| ZzzQuil Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | ad4babdb-d98d-420e-b8b0-9a5368c89a44 | 2026-03-12 | Warnings | M010 |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8dc17b5d-1cf7-44d2-9e78-d2c6952c7d20 | 2026-03-11 | Warnings | M010 |
| sleep aid | DIPHENHYDRAMINE HCL | Rite Aid Corporation | bdfd7d87-2b54-4c29-ba69-aad0fab682e7 | 2026-03-11 | Warnings | M010 |
| ZzzQuil Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | 1d608c94-1651-f318-e063-6294a90aa11e | 2026-03-05 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 5ef35ab9-b6e8-4c88-a623-35ac9d6bd359 | 2026-03-05 | Warnings | M010 |
| ZzzQuil Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | e441c952-cd48-4159-ada2-271ca7541600 | 2026-02-20 | Warnings | M010 |
| Vicks ZzzQuil NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVER | DIPHENHYDRAMINE HCL, ACETAMINOPHEN | The Procter & Gamble Manufacturing Company | 065d760b-70a5-3e26-e063-6394a90a48cd | 2026-02-20 | Warnings | M010 |
| Sleep-Aid | DIPHENHYDRAMINE HCL | WALMART INC. (see also Equate) | 84c37f4d-60f6-490e-ba8b-47d1257fa6f8 | 2026-02-13 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | P & L Development, LLC | 59c063ad-6ea3-4f1d-a20e-5e5e062a9098 | 2026-02-10 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | f446e56f-c664-4092-8712-aa3f204172f8 | 2026-02-02 | Warnings | M010 |
| Sleep Aid Night Time | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | d805fab3-9dca-497f-bdc6-c8a7b1736109 | 2026-01-27 | Warnings | M010 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 0e45d0e8-3741-7cee-e063-6394a90a2de5 | 2026-01-27 | 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 |