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 capsule every 4-6 hours; not more than 6 doses in 24 hours children under 12 years: ask a doctor
(in each capsule)
Diphenhydramine HCl 50 mg
Antihistamine
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
Do not use with 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 are taking 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 50 MG
ANTIHISTAMINE
NDC: 54738-116-01– 100 COUNT
NDC: 54738-116-03– 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0054738116014 | GTIN-13: 0054738116014 EAN-13: 0054738116014 GTIN-12: 054738116014 UPC-A: 054738116014 GTIN storage (14 digits): 00054738116014 | IMG_4682.jpg |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54738-116-01 | Diphenhydramine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | 2 | |
| 54738-116-03 | Diphenhydramine Hydrochloride | 1000 in 1 BOTTLE | CAPSULE | 1000 | 2 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54738-116-01 | EA - Each | 54738-116 | de51d6f9-9d96-4ca6-a402-797d803b061f | 1 | 2017-11-06 |
| 54738-116-03 | EA - Each | 54738-116 | 2375fe3e-94f9-4410-ba4b-38af72221de3 | 1 | 2017-11-06 |
| 54738-116-13 | EA - Each | 54738-116 | f14c9574-5961-47ef-b3d1-da2fac68a61a | 1 | 2013-06-04 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54738-116 | 54738-116-01, 54738-116-03 |
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 | 54738-116 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Richmond Pharmaceuticals, Inc. | ab67121e-2477-47dd-a7ec-114453df3fd4 | 2017-10-30 | Warnings | 54738-116-03 54738-116-01 54738-116 54738011601 54738011603 5cc3bf1b-466c-6a53-e053-2a91aa0abfa6 ab67121e-2477-47dd-a7ec-114453df3fd4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.