temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing
take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age
Active ingredient (in each capsule)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
temporarily relieves these symptoms due to the common cold: runny nose sneezing
to make a child sleepy
with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
| adults and children
12 years of age and over | 1 to 2 capsules |
| children 6 to
under 12 years of age | 1 capsule |
| children under 6 years of age | do not use this product
in children under 6 years of age |
store in a dry place at 15° – 30°C (59° – 86°F)
corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate
1-800-616-2471
Distributed by: MAJOR® PHARMACEUTICALS, Indianapolis, IN 46268
*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Benadryl®.
RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION
DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.
DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.
Major
BENOPHEN
NDC 0904-7237-24
Diphenhydramin HCl 25 mg
Antihistamine
For the temporary relief of the symptoms of:
• Upper Respiratory Allergies
• Hay Fever
Compare to the active ingredient in BENADRYL® Allergy*
24 CAPSULES
EACH CAPSULE INDIVIDUALLY
BANDED FOR YOUR PROTECTION
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-7237-24 | Diphenhydramine Hydrochloride | 2 in 1 CARTON | CAPSULE | 2 | 4 | |
| 0904-7237-24 | Diphenhydramine Hydrochloride | 12 in 1 BLISTER PACK | CAPSULE | 12 | 4 | |
| 0904-7237-60 | Diphenhydramine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | 4 | |
| 0904-7237-61 | Diphenhydramine Hydrochloride | 10 in 1 BOX, UNIT-DOSE | CAPSULE | 10 | 4 | |
| 0904-7237-61 | Diphenhydramine Hydrochloride | 10 in 1 BLISTER PACK | CAPSULE | 10 | 4 | |
| 0904-7237-80 | Diphenhydramine Hydrochloride | 1000 in 1 BOTTLE | CAPSULE | 1000 | 4 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7237-24 | EA - Each | 0904-7237 | 0f407112-e93a-4544-a880-485bfe00249e | 1 | 2022-11-07 |
| 0904-7237-60 | EA - Each | 0904-7237 | 0ee1a165-13f2-4f89-b39c-1c8f9e940d28 | 1 | 2022-10-06 |
| 0904-7237-61 | EA - Each | 0904-7237 | 9d1b9365-5c30-45de-8071-c9a0262ad0c8 | 1 | 2023-01-09 |
| 0904-7237-80 | EA - Each | 0904-7237 | a9264169-ed21-468e-860b-7bb8a0f84062 | 1 | 2022-11-07 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0904-7237 | 0904-7237-80, 0904-7237-60, 0904-7237-24, 0904-7237-61 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| GELATIN | 2G86QN327L | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| STARCH, CORN | O8232NY3SJ | 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 |
|---|---|---|---|---|---|---|
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | dca04d80-e781-40b1-e053-2995a90a7010 | 2026-02-20 | Warnings | 0904-7237-80 0904-7237-61 0904-7237-24 0904-7237-60 0904-7237 00904723724 00904723760 00904723761 00904723780 4b433ad6-a0bd-3f85-e063-6394a90a0785 dca04d80-e781-40b1-e053-2995a90a7010 |
Adverse event summaries are temporarily unavailable. Other product information remains available.