Indications and uses
• Temporarily relieves these symptoms due to hay fever or other respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat
Diphenhydramine HCl Oral Solution
- Manufacturer
- Rising Pharma Holdings, Inc.
- Effective date
- 2025-07-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:06:49
Label at a glance#
ProductDiphenhydramine HCl Oral Solution
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections
Dosage and administration
• take every 4 to 6 hours, or as directed by a physician • do not take more than 6 doses in 24 hours age dose Adults and children over 12 years of age 10 mL (25 mg) to 20 mL (50 mg) Children 6 to under 12 years of age 10 mL (25 mg) Children under 6 years of age Do not use
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient per 10 mL (1 Unit Dose)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
Uses
• Temporarily relieves these symptoms due to hay fever or other respiratory allergies:
• runny nose • sneezing • itchy, watery eyes • itching of the nose or throat
Warnings
Do not use
• 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 chronic bronchitis
• glaucoma
• trouble urinating due to enlarged prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
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 traquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children
SPL UNCLASSIFIED SECTION
If pregnant or breast-feeding, ask a healthcare professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Directions
• take every 4 to 6 hours, or as directed by a physician
• do not take more than 6 doses in 24 hours
| age | dose |
|---|---|
| Adults and children over 12 years of age | 10 mL (25 mg) to 20 mL (50 mg) |
| Children 6 to under 12 years of age | 10 mL (25 mg) |
| Children under 6 years of age | Do not use |
Other information
• each 10 mL contains sodium: 6 mg
• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• do not use if lid is torn or broken
INACTIVE INGREDIENT SECTION
Inactive ingredients: citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose
OTC - QUESTIONS SECTION
Questions or comments? Call 1-844-474-7464
SPL UNCLASSIFIED SECTION
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
FG-36/Iss.:10/2023
NDC Information -
25 mg/10 mL
Each 10 mL of Diphenhydramine HCl Oral Solution contains Diphenhydramine HCl 25 mg and is supplied in the following oral dosage forms:
NDC 57237-318-01: 10 mL unit dose cup
NDC 57237-318-11: 100 x 10 mL Unit-Dose Cups
PRINCIPAL DISPLAY PANEL
25 mg/10 mL
Case Label NDC 57237-318-11
Lid Label NDC 57237-318-01
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 3 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 3 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | 3 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | 3 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 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 |
|---|---|---|---|---|---|---|
| 57237-318-01 | Diphenhydramine HCl Oral Solution | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | 3 | |
| 57237-318-11 | Diphenhydramine HCl Oral Solution | 100 in 1 BOX, UNIT-DOSE | SOLUTION | 100 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-318-01 | ML - Milliliter | 57237-318 | 68c91723-6496-40f9-acb3-9533ba0ffe84 | 1 | 2024-04-05 |
| 57237-318-11 | ML - Milliliter | 57237-318 | 1e834ec8-4814-45ec-884d-f12e845892f7 | 1 | 2024-03-12 |
Products#
Every source-derived product name is available through these pages.
- Diphenhydramine HCl Oral Solution
- Diphenhydramine HCl Oral
- CITRIC ACID MONOHYDRATE
- FD&C RED NO. 40
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- SODIUM CITRATE
- SUCRALOSE
- WATER
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57237-318 | 57237-318-01, 57237-318-11 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| WATER | 059QF0KO0R | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HCL ORAL | Rising Pharma Holdings, Inc. | 8f0ba9e5-a31d-4d77-8155-c16c7e74edef | 2025-07-01 | Warnings | 57237-318-11 57237-318-01 57237-318 57237031801 57237031811 deb36161-32a5-4e95-9837-fd12ca2c3778 8f0ba9e5-a31d-4d77-8155-c16c7e74edef |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.