OTC - ACTIVE INGREDIENT SECTION
Diphenhydramine HCl 25mg
Diphenhydramine HCl 25mg
Sleep-aid
polyethylene glycol, propylene glycol, FD&C blue # 1, FD&C red # 40, gelatin, glycerin, sorbitol 70%, povidone, purified water.
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70692-784-02 | 2022-04-12 | C162847 | 48780-1 | d6a99b39-7f7d-a426-e053-dadaa90af4c2 | Sleep-Aid Diphenhydramine HCl 25mg (Purple Softgel) |
| 70692-784-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7f7d-a426-e053-dadaa90af4c2 | Sleep-Aid Diphenhydramine HCl 25mg (Purple Softgel) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70692-784-02 | Diphenhydramine Hydrochloride | 20 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 20 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70692-784 | 70692-784-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| SORBITOL | 506T60A25R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
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 |
|---|---|---|---|---|---|---|
| 8afba990-140d-4ab7-985a-f8ce27d8b661 | 96a07573-f3bd-528c-e053-2995a90a81c5 | 2024-01-01 | Warnings | 8afba990-140d-4ab7-985a-f8ce27d8b661 96a07573-f3bd-528c-e053-2995a90a81c5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.