FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Manufacturer
Physicians Total Care, Inc.
Effective date
2012-06-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:21

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itching of the nose or throat runny nose itchy, watery eyes temporarily relieves these symptoms due to the common cold: sneezing runny nose

Dosage and administration

if needed, take every 4-6 hours do not take more than 6 doses in 24 hours children under 4 years of age do not use children 4 to under 6 years of age do not use unless directed by a doctor children 6 to under 12 years of age 1 to 2 teaspoonfuls (12.5 mg to 25 mg) adults and children 12 years of age and over 2 to 4 teaspoonfuls (25 mg to 50 mg)

Storage and handling

each teaspoonful contains: sodium 15 mg store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • temporarily relieves these symptoms due to the common cold:
  • sneezing
  • runny nose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • if needed, take every 4-6 hours
  • do not take more than 6 doses in 24 hours

children under 4

years of age		do not use

children 4 to under 6

years of age		do not use unless directed by a doctor

children 6 to under

12 years of age

1 to 2 teaspoonfuls

(12.5 mg to 25 mg)

adults and children

12 years of age

and over

2 to 4 teaspoonfuls

(25 mg to 50 mg)

Other information

STORAGE AND HANDLING SECTION

  • each teaspoonful contains: sodium 15 mg
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Diphenhydramine Hydrochloride

12.5 mg/ 5 mL

NDC 54868-5622-0

image of package labelimage of package label

Relieves:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

See New Warning and Dosing Directions

Cherry Flavored

4 fl oz (118 mL)

Alcohol Free



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN1
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD1
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-5622-02019-09-24C16284748780-19350213a-47a5-c013-e053-90daa90a139384f14898-dbdc-408e-a521-c88fd8290f4b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-5622-0Diphenhydramine Hydrochloride1 in 1 CARTONLIQUID11
54868-5622-0Diphenhydramine Hydrochloride118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-5622DIPHENHYDRAMINE HYDROCHLORIDE LIQUID [PHYSICIANS TOTAL CARE, INC.]12 package rows20120621_84f14898-dbdc-408e-a521-c88fd8290f4b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-379-26ML - Milliliter24385-379b20dc66e-3f68-4533-a6ef-5ed3041a3a2e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M21
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54868-562254868-5622-0
24385-379

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 1 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SOLUTION / ORAL50 mg/5mlExact identifier — unii+route+dosage form
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSOLUTION / ORAL2 mgExact identifier — unii+route+dosage form
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii+route+dosage form
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSOLUTION / ORAL10000 mgExact identifier — unii+route+dosage form
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEAmerisource Bergenb173cc2c-7c4c-4f9e-a920-c71bc256ec1e2024-07-18WarningsExact identifier
ndc (product): 24385-379
fba49e33-36bd-48c5-8500-fd36b9cacb7c84f14898-dbdc-408e-a521-c88fd8290f4b2012-06-05WarningsExact identifier
spl id: fba49e33-36bd-48c5-8500-fd36b9cacb7c
spl set id: 84f14898-dbdc-408e-a521-c88fd8290f4b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.