Diphenhydramine HCl 25mg
- Product NDC
- 69168-002
- 11-digit product format
- 691680002
- Labeler code
- 69168
- Product ID
- 69168-002_36c028e5-005a-42eb-958c-9fed406827b3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sleep Aid
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Allegiant Health
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-11-23
- 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
- Diphenhydramine HCl 25mg
- 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 |
|---|---|
| 2890e4ba-d642-437d-8a86-24996a74e027 | 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 |
|---|---|---|---|---|---|---|
| 69168-002-93 | Diphenhydramine HCl 25mg | 24 in 1 CARTON | TABLET, COATED | 24 | 4 |
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 | 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 |
| 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 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 5ef35ab9-b6e8-4c88-a623-35ac9d6bd359 | 2026-03-05 | 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 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Softgel Healthcare Pvt Ltd | 335b09c6-ee5d-ebdf-e063-6294a90abd12 | 2026-01-27 | Warnings | M010 |
| Diphenhydramine hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Softgel Healthcare Pvt Ltd | 32033991-a4f0-f767-e063-6394a90a0b06 | 2026-01-27 | Warnings | M010 |
| NIGHTTIME SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | Wal-Mart Stores Inc | 90506598-046f-48d3-b8f5-d6ead0333812 | 2026-01-27 | Warnings | M010 |
| DORMMY-LON | DIPHENHYDRAMINE HYDROCHLORIDE | Haendel Farma, S.A. de C.V. | 562db961-83cb-4b74-9f34-fecee2c1be17 | 2026-01-27 | Warnings | M010 |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HCL | Better Living Brands, LLC | dec955d3-817d-454f-b146-9a631e908dbc | 2026-01-27 | Warnings | M010 |
| NIGHTTIME SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | Prodose, Inc. | c4bc3efd-8ca8-22fe-e053-2a95a90aed45 | 2026-01-26 | Warnings | M010 |
| NIGHTTIME SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN COMPANY | f000d0b5-8ee8-4db0-99fe-aae5ed20c98e | 2026-01-19 | Warnings | M010 |
| Unisom SleepMinis Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | Chattem, Inc. | a9a44c2f-65eb-4a5a-9e72-43652dce57f7 | 2026-01-14 | Warnings | M010 |
| Unisom SleepMelts Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Chattem, Inc. | 9105f4f1-7f94-408d-a025-83afb68dc9f0 | 2026-01-14 | Warnings | M010 |
| Rest Simply | DIPHENHYDRAMINE HYDROCHLORIDE | HYVEE INC | 462ca6cd-8eec-09df-e063-6294a90ac880 | 2026-01-13 | Warnings | M010 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 2890e4ba-d642-437d-8a86-24996a74e027 | 4 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 2890e4ba-d642-437d-8a86-24996a74e027 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69168-002-93 | 69168000293 | 24 TABLET, COATED in 1 CARTON (69168-002-93) | 2021-11-23 | 0000-00-00 | No | No | Current |