Indications and 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
Allergy
- Manufacturer
- Accudial Pharmaceutical, Inc. | Bio-Pharm, Inc.
- Effective date
- 2013-02-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:34:40
Label at a glance#
ProductAllergy
Active ingredientDiphenhydramine Hydrochloride
Label structure11 sections
Dosage and administration
may be given every 4 to 6 hours do not use more than 6 times in 24 hours use only enclosed dosing cup to dose this product. Do not use any other dosing device.
Storage and handling
each teaspoon contains: sodium 7 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 5 mL = 1 teaspoon)
Diphenhydramine, USP HCl 12.5 mg.
Purpose
Antihistamine
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
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
- a sodium-restricted diet
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.
When using this product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children.
OTC - ASK DOCTOR/PHARMACIST SECTION
Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.
| Age (yr) | Dose (TSP) |
|---|---|
| TSP = teaspoon | |
| under 6 yrs. | ask a doctor |
| 6 to under 12 | 1-2 TSP |
| or as directed by a doctor | |
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.
Other information
- each teaspoon contains: sodium 7 mg
- store between 20°-25°C (68°-77°F)
- tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.
Directions
- may be given every 4 to 6 hours
- do not use more than 6 times in 24 hours
- use only enclosed dosing cup to dose this product. Do not use any other dosing device.
Questions?
877-434-2036
Inactive ingredients
artificial flavor, citric acid anhydrous, CMC sodium, glycerin, polysorbate, propylene glycol, purified water, sodium benzoate, sodium saccharin, sodium citrate dihydrate, sorbitol solution.
SPL UNCLASSIFIED SECTION
Distributed by: AccuDial® Pharmaceutical, Inc. Palm Beach Gardens, FL 33408
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
ACCUDIAL ®
Children's
Allergy
Diphenhydramine HCl
Oral Solution Antihistamine
Relieves Sneezing
• Itchy, Watery Eyes
Runny Nose • Itchy Throat
Earth-Friendly
Package!
For Ages 6 yrs to under 12 yrs
Tamper Evident
Compares to Children's
Benadryl® Allergy
Dye-Free
BUBBLEGUM
FLAVOR
NDC 45014-161-04
4 FL. OZ. (118 mL)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 1 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 1 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | 1 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | 1 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | 1 |
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 |
|---|---|---|---|---|---|
| 45014-161-04 | 2019-11-27 | C162847 | 48780-1 | 9855d018-dc0a-cd31-e053-dbdaa90ab51a | Allergy |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45014-161-04 | Allergy | 118 mL in 1 BOTTLE | LIQUID | 118 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Diphenhydramine Hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| Diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| Anhydrous Citric Acid | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Saccharin Sodium | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| Sodium | INACTIVE INGREDIENT | 9NEZ333N27 | 1 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| Trisodium Citrate Dihydrate | INACTIVE INGREDIENT | B22547B95K | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Allergy
- Diphenhydramine Hydrochloride
- Diphenhydramine
- Anhydrous Citric Acid
- Sodium
- Glycerin
- Polysorbate 20
- Propylene Glycol
- Water
- Sodium Benzoate
- Saccharin Sodium
- Trisodium Citrate Dihydrate
- Sorbitol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 45014-161 | 45014-161-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Diphenhydramine Hydrochloride | TC2D6JAD40 | ACTIB |
| Anhydrous Citric Acid | XF417D3PSL | IACT |
| Sodium | 9NEZ333N27 | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Polysorbate 20 | 7T1F30V5YH | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Water | 059QF0KO0R | IACT |
| Sodium Benzoate | OJ245FE5EU | IACT |
| Saccharin Sodium | SB8ZUX40TY | IACT |
| Trisodium Citrate Dihydrate | B22547B95K | IACT |
| Sorbitol | 506T60A25R | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | CLOTH / TOPICAL | NA | ||
| Sorbitol | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION, EXTENDED RELEASE / ORAL | 24 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| Trisodium Citrate Dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SYRUP / ORAL | 705 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EXTENDED RELEASE / ORAL | 312 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| Trisodium Citrate Dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SOLUTION / INTRAOCULAR | 27 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | CAPSULE / ORAL | 563 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY, METERED / NASAL | 1.2 mg/1ml | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SOLUTION / INTRAVENOUS | 30 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, FILM COATED / ORAL | 1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / DENTAL | 0.05 %w/v | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | CONCENTRATE / ORAL | 6 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SYSTEM / TOPICAL | 2 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / SUBLINGUAL | 7 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | PASTE / ORAL | 26 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, EXTENDED RELEASE / ORAL | 4.2 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRAMUSCULAR | 101 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| Trisodium Citrate Dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SOLUTION / OPHTHALMIC | 0.45 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INFILTRATION | 0.02 %w/v | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | GEL / TOPICAL | 5 %w/w | ||
| Sorbitol | SORBITOL | 506T60A25R | INJECTION / SUBCUTANEOUS | 4.7 %w/v | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / RESPIRATORY (INHALATION) | 5 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FOR SUSPENSION / ORAL | 6 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| Trisodium Citrate Dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 22 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| Trisodium Citrate Dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | POWDER / RESPIRATORY (INHALATION) | 17 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | CONCENTRATE / ORAL | 20 mg | ||
| Trisodium Citrate Dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | INJECTION / SUBCUTANEOUS | 75 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / TOPICAL | 0.01 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | LOTION / TOPICAL | 10.7 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg |
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 |
|---|---|---|---|---|---|---|
| f8c91261-b067-4bea-810b-6b28dc893b0e | cb18f535-1876-4d1b-962a-a9fde8f180bb | 2013-02-06 | Warnings | f8c91261-b067-4bea-810b-6b28dc893b0e cb18f535-1876-4d1b-962a-a9fde8f180bb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.