Diphenhydramine Oral Liquid

Manufacturer: Rij Pharmaceutical Corporation
Effective date: 2018-04-30
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:55:21

Label at a glance#

ProductDiphenhydramine Oral Liquid

Active ingredientDiphenhydramine Hydrochloride

Label structure8 sections

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 temporarily relieves these symptoms due to common cold: runny nose sneezing

Storage and handling

• store at room temperature 15º - 30ºC (59º - 86ºF) • protect from freezing. • protect from light. • each teaspoon (5 mL) contains: sodium 16 mg • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient in each 5 mL ( in one teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl, USP 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:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

temporarily relieves these symptoms due to common cold:

runny nose
sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

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

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

take every 4-6 hours
Do not use more than 6 times in 24 hours

adults and children 12 years of age and over	2 to 4 teaspoonfuls (25 to 50 mg)
children 6 to under 12 years of age	1 to 2 teaspoonfuls (12.5 to 25 mg)
children under 6 years	ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at room temperature 15º - 30ºC (59º - 86ºF)
protect from freezing.
protect from light.
each teaspoon (5 mL) contains: sodium 16 mg
TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
NDC	Effective	Action	Document	Indexing SPL	Related label
53807-204-04	2020-01-31	C162847	48780-1	9d75b9d0-7d35-f424-e053-dadaa90a57ce	Drug Facts
53807-204-08	2020-01-31	C162847	48780-1	9d75b9d0-7d35-f424-e053-dadaa90a57ce	Drug Facts
53807-204-16	2020-01-31	C162847	48780-1	9d75b9d0-7d35-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53807-204-04	Diphenhydramine Oral Liquid	118 mL in 1 BOTTLE	LIQUID	118	2
53807-204-08	Diphenhydramine Oral Liquid	236 mL in 1 BOTTLE	LIQUID	236	2
53807-204-16	Diphenhydramine Oral Liquid	473 mL in 1 BOTTLE	LIQUID	473	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53807-204	DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	2	Legacy NDC, 3 package rows	20180502_af5b9c99-03b8-4cf3-80d5-e484b36b6873.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53807-204-04	ML - Milliliter	53807-204	3b81fe99-dfdb-447a-966c-6f1d15b68c5b	1	2014-06-03
53807-204-08	ML - Milliliter	53807-204	cb2375b2-0867-4db6-a2ef-0ce7bce07251	1	2014-06-03
53807-204-16	ML - Milliliter	53807-204	2f08347f-f1e5-4333-9297-86d671b0990b	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Diphenhydramine Hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	1
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	1
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Diphenhydramine Oral Liquid
Diphenhydramine Hydrochloride
Diphenhydramine
Anhydrous Citric Acid
D&C RED NO. 33
FD&C RED NO. 40
Sodium Benzoate
SODIUM CITRATE
Saccharin Sodium
SORBITOL
SUCROSE
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53807-204	53807-204-04, 53807-204-08, 53807-204-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Diphenhydramine Hydrochloride	TC2D6JAD40	ACTIB
Anhydrous Citric Acid	XF417D3PSL	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
Sodium Benzoate	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
Saccharin Sodium	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
SUCROSE	C151H8M554	IACT
Water	059QF0KO0R	IACT

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 5 · 264 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	CREAM / TOPICAL		1 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	LIQUID / INTRAVENOUS		18 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / RESPIRATORY (INHALATION)		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	GUM, CHEWING / BUCCAL		48 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION/ DROPS / AURICULAR (OTIC)		1 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	CLOTH / TOPICAL	4.2 mg		Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		35 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	GEL / RECTAL		406 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / INTRAMUSCULAR		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / BUCCAL	0.01 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CONCENTRATE / ORAL	0.02 mg/1ml		Exact identifier — unii candidate 14 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		48 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	GEL / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	GEL / TOPICAL		5 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL	ADJ PH		Exact identifier — unii candidate 61 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	ELIXIR / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / ORAL		84 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / TOPICAL	4.35 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e241709f-9874-407f-8de4-440c768d5b79			af5b9c99-03b8-4cf3-80d5-e484b36b6873	2018-04-30	Warnings	Exact identifier spl id: e241709f-9874-407f-8de4-440c768d5b79 spl set id: af5b9c99-03b8-4cf3-80d5-e484b36b6873

Reported adverse events (FAERS/openFDA)#

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

Diphenhydramine Oral Liquid

Label at a glance#

Indications and uses

Storage and handling

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Active ingredient in each 5 mL ( in one teaspoonful)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

When using this product

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#