Nighttime SleepAid
- Product NDC
- 61504-091
- 11-digit product format
- 615040091
- Labeler code
- 61504
- Product ID
- 61504-091_44099896-a7cb-1e99-e063-6294a90a383f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- AMERIFOODS TRADING COMPANY
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-11-20
- 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 SleepAid
- 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 |
|---|---|
| 3802d57e-7943-c0c2-e063-6394a90a7580 | 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 |
|---|---|---|---|---|---|---|
| 61504-091-03 | Nighttime SleepAid | 1 in 1 CARTON | TABLET, COATED | 1 | 2 | |
| 61504-091-03 | Nighttime SleepAid | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 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 |
|---|---|---|---|---|---|---|
| NIGHTTIME SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN COMPANY | e96ec4d4-53b9-4636-a58c-1a5923a021ad | 2025-10-31 | Warnings | M010 |
| GOODNOW SLEEP AID | DIPHENHYDRAMINE HCL | Gobrands, Inc | 7d821b7d-6a31-4ff7-b587-51907ba62658 | 2025-10-29 | Warnings | M010 |
| Sominex | DIPHENHYDRAMINE HYDROCHLORIDE | Medtech Products Inc. | f7858ecf-8498-4465-85d8-3e7814737573 | 2025-10-23 | Warnings | M010 |
| Sominex Max | DIPHENHYDRAMINE HCL | Medtech Products Inc. | e8f6991f-c47a-4d12-934b-04fdf092dac3 | 2025-10-23 | Warnings | M010 |
| 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 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 3802d57e-7943-c0c2-e063-6394a90a7580 | 2 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 3802d57e-7943-c0c2-e063-6394a90a7580 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 61504-091-03 | 61504009103 | 1 BOTTLE, PLASTIC in 1 CARTON (61504-091-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2025-11-20 | No | No | Current |