Indications and uses
temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose itchy nose or throat sneezing itchy, watery eyes
temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose itchy nose or throat sneezing itchy, watery eyes
adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours children under 12 years: ask a doctor
(in each capsule)
Diphenhydramine HCl 25 mg
Antihistamine
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
Do not usewith any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers
When using this product
If pregnant or breast-feeding,ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED
call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 25 MG -
ANTIHISTAMINE
NDC: 54738-115-24
– 24 COUNT
NDC: 54738-115-01– 100 COUNT
NDC: 54738-115-03– 1000 COUNT(THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)
| 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 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54738-115-01 | Diphenhydramine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | 4 | |
| 54738-115-03 | Diphenhydramine Hydrochloride | 1000 in 1 BOTTLE | CAPSULE | 1000 | 4 | |
| 54738-115-24 | Diphenhydramine Hydrochloride | 24 in 1 BOTTLE | CAPSULE | 24 | 4 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54738-115-01 | EA - Each | 54738-115 | aa025503-0131-4230-9622-c5356c149397 | 1 | 2017-11-06 |
| 54738-115-03 | EA - Each | 54738-115 | a1497aeb-1eea-4102-9a9d-26de004a9dcf | 1 | 2017-11-06 |
| 54738-115-13 | EA - Each | 54738-115 | aacf6bf3-019c-4e4d-a412-049eb1c8a747 | 1 | 2013-06-04 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54738-115 | 54738-115-24, 54738-115-01, 54738-115-03 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| BUTYLPARABEN | 3QPI1U3FV8 | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| LACTOSE | J2B2A4N98G | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Richmond Pharmaceuticals Inc. | f184b2aa-91a4-44f9-b688-d4e318181984 | 2024-12-26 | Warnings | 54738-115 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Richmond Pharmaceuticals, Inc. | 2792032a-ff0f-4d5f-a8e3-b8b8c54f4e99 | 2024-12-26 | Warnings | 54738-115-03 54738-115-01 54738-115-24 54738-115 54738011501 54738011503 54738011524 2a329845-3f42-540c-e063-6394a90af0a9 2792032a-ff0f-4d5f-a8e3-b8b8c54f4e99 |
Adverse event summaries are temporarily unavailable. Other product information remains available.