Diphenhydramine HCL
- Manufacturer
- Belleview Biosciences
- Effective date
- 2025-06-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:02:50
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
DOSAGE & ADMINISTRATION SECTION
Directions: Take every 4-6 hours, or as directed by doctor. * Do NOT exceed the recommended dose
| Age | Dose |
| Adults and Children 12 years of age and over | take 10 to 20 mL (2 to 4 tsp), not to exceed 300 mg in 24 hours |
| Children 6 to under 12 years of age | take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours |
| Children under 6 years of age | Consult a doctor |
WARNINGS SECTION
Warnings:
Do not use: ■ with any other product containing
diphenhydramine, even one used on skin ■ to make a
child sleepy
Ask a doctor before use if you have: ■ a breathing
problem such as emphysema or chronic bronchitis
■ glaucoma ■ trouble urinating due to the enlarged
prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product: ■ excitability might occur,
especially in children ■ marked drowsiness may occur
■ avoid alcoholic drinks ■ alcohol, sedatives, and
tranquilizers may increase drowsiness effect ■ be careful
when driving a motor vehicle or operating machinery
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 (1-800-222-1222) right away.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Citric Acid,
Flavor, Methylparaben, Monoammonium
Glycyrrhizinate, Potassium Citrate, Propylene Glycol,
Propylparaben, Purified Water, Sorbitol, Sucralose
INDICATIONS & USAGE SECTION
Uses: 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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a
Poison Control Center (1-800-222-1222) right away.
OTC - PURPOSE SECTION
Purpose: Antihistamine
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each 5 mL tsp)
Diphenhydramine HCL, 12.5 mg
Drug Facts
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 2 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 2 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | 2 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | 2 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | 2 |
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 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| 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 |
|---|---|---|---|---|---|---|
| 84447-103-01 | Diphenhydramine HCL | 200000 mL in 1 DRUM | SOLUTION | 200000 | 2 | |
| 84447-103-04 | Diphenhydramine HCL | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 2 | |
| 84447-103-16 | Diphenhydramine HCL | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 84447-103-16 | ML - Milliliter | 84447-103 | 3fbeb6a1-3362-4f18-b499-87b41d9d205c | 1 | 2025-07-08 |
Products#
Every source-derived product name is available through these pages.
- Diphenhydramine HCL
- WATER
- NONCRYSTALLIZING SORBITOL SOLUTION
- PROPYLENE GLYCOL
- SUCRALOSE
- CITRIC ACID
- POTASSIUM CITRATE
- METHYLPARABEN
- PROPYLPARABEN
- AMMONIUM GLYCYRRHIZINATE TRIHYDRATE
- CHERRY
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84447-103 | 84447-103-16, 84447-103-04, 84447-103-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| NONCRYSTALLIZING SORBITOL SOLUTION | 9E0S3UM200 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| CITRIC ACID | 2968PHW8QP | IACT |
| POTASSIUM CITRATE | EE90ONI6FF | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| AMMONIUM GLYCYRRHIZINATE TRIHYDRATE | 78NEL3149I | IACT |
| CHERRY | BUC5I9595W | 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 | DIPHENHYDRAMINE HCL | Belleview Biosciences | 1db57d86-39f0-f8ca-e063-6394a90a6397 | 2025-06-12 | Warnings | 84447-103-16 84447-103-01 84447-103-04 84447-103 84447010304 84447010316 84447010301 3765beab-e853-b34f-e063-6394a90ac9d5 1db57d86-39f0-f8ca-e063-6394a90a6397 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
