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
- Major Pharmaceuticals
- Effective date
- 2025-09-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:12:38
Label at a glance#
ProductDiphenhydramine HCl Oral Solution
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 sections
Dosage and administration
For the 5 mL Unit-Dose: • take every 4 to 6 hours, or as directed by a physician • do not take more than 6 doses in 24 hours age dose Children under 2 years of age Do not use Children 2 to under 6 years of age Do not use unless directed by a doctor Children 6 to under 12 years of age 5 mL (12.5 mg) to 10 mL (25 mg)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient per 5 mL (1 Unit Dose)
Diphenhydramine HCl 12.5 mg
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 the child has
• a breathing problem such as chronic bronchitis
• glaucoma
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers
When using this product
• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in children
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
For the 5 mL Unit-Dose:
• take every 4 to 6 hours, or as directed by a physician
• do not take more than 6 doses in 24 hours
| age | dose |
|---|---|
Children under 2 years of age | Do not use |
Children 2 to under 6 years of age | Do not use unless directed by a doctor |
Children 6 to under 12 years of age | 5 mL (12.5 mg) to 10 mL (25 mg) |
Directions
For the 10 mL Unit-Dose:
• take every 4 to 6 hours, or as directed by a physician
• do not take more than 6 doses in 24 hours
| age | dose |
|---|---|
Children under 6 years of age | Do not use |
Children 6 to under 12 years of age | 10 mL (25 mg) |
Adults and children 12 years of age and over | 10 mL (25 mg) to 20 mL (50 mg) |
Other information
• each 5 mL contains sodium: 3 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? (855) 879-4368
SPL UNCLASSIFIED SECTION
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
PRINCIPAL DISPLAY PANEL
MAJOR®
NDC 0904-7323-41
Each 5 mL Contains:
Diphenhydramine HCL Oral Solution
12.5 mg/5 mL
Antihistamine
Delivers 5 mL • See insert
For Institutional Use Only
Cherry Flavor
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Sugar Free • Alcohol Free
PRINCIPAL DISPLAY PANEL
MAJOR®
NDC 0904-7324-66
Each 10 mL Contains:
Diphenhydramine HCL Oral Solution
25 mg/10 mL
Antihistamine
Delivers 10 mL • See insert
For Institutional Use Only
Cherry Flavor
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Sugar Free • Alcohol Free
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 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0904-7323-70 | 2025-09-05 | C162847 | 48780-1 | 3b156c62-2cc4-fb37-e063-e6dba90a4e07 | Diphenhydramine HCl Oral Solution 12.5 mg/5 mL Diphenhydramine HCl Oral Solution 25 mg/10 mL |
| 0904-7324-72 | 2025-09-05 | C162847 | 48780-1 | 3b156c62-2cc4-fb37-e063-e6dba90a4e07 | Diphenhydramine HCl Oral Solution 12.5 mg/5 mL Diphenhydramine HCl Oral Solution 25 mg/10 mL |
| 0904-7323-70 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2cc4-fb37-e063-e6dba90a4e07 | Diphenhydramine HCl Oral Solution 12.5 mg/5 mL Diphenhydramine HCl Oral Solution 25 mg/10 mL |
| 0904-7324-72 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2cc4-fb37-e063-e6dba90a4e07 | Diphenhydramine HCl Oral Solution 12.5 mg/5 mL Diphenhydramine HCl Oral Solution 25 mg/10 mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-7323-41 | Diphenhydramine HCl Oral Solution | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | 3 | |
| 0904-7323-70 | Diphenhydramine HCl Oral Solution | 100 in 1 BOX, UNIT-DOSE | SOLUTION | 100 | 3 | |
| 0904-7324-66 | Diphenhydramine HCl Oral Solution | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | 3 | |
| 0904-7324-72 | 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 |
|---|---|---|---|---|---|
| 0904-7323-41 | ML - Milliliter | 0904-7323 | 47566786-0115-4f2c-a09c-6efe34eb2a5d | 1 | 2024-02-14 |
| 0904-7323-70 | ML - Milliliter | 0904-7323 | 3f6eb9cc-7877-408b-a71d-89c6bd98de27 | 1 | 2024-02-14 |
| 0904-7324-66 | ML - Milliliter | 0904-7324 | 74472206-0479-4f4c-b6d3-573b13ef16d3 | 1 | 2024-02-14 |
| 0904-7324-72 | ML - Milliliter | 0904-7324 | 88a687b1-dcda-4213-a14c-c9ef572f5e8c | 1 | 2024-02-14 |
Products#
Every source-derived product name is available through these pages.
- Diphenhydramine HCl Oral Solution
- Diphenhydramine HCl Oral
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- CITRIC ACID MONOHYDRATE
- FD&C RED NO. 40
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE, UNSPECIFIED FORM
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0904-7323 | 0904-7323-41, 0904-7323-70 |
| 0904-7324 | 0904-7324-66, 0904-7324-72 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 425e484b-f7c7-4776-8d72-9a5bfb4f6dc5 | 0f9015c9-a95a-5703-e063-6394a90a6ad2 | 2025-09-04 | Warnings | 425e484b-f7c7-4776-8d72-9a5bfb4f6dc5 0f9015c9-a95a-5703-e063-6394a90a6ad2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.