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 22:32:22

Label at a glance#

ProductDiphenhydramine Hydrochloride

Active ingredientDiphenhydramine Hydrochloride

Label structure10 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

Dosage and administration

take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years and over 2 to 4 teaspoons (25 mg to 50 mg) children 6 to under 12 years ask a doctor children 4 to 5 years do not use unless directed by a doctor children under 4 years do not use

Storage and handling

each teaspoon (5 mL) contains: sodium 5 mg store between 20°-25°C (68°-77°F). Protect from light.

Contacts and useful links#

PhoneLabel contact1-888-838-2872

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each teaspoon (5 mL))

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl USP 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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

to make a child sleepy
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

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 machinery
excitability may occur, especially in children

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

adults and children 12 years and over	2 to 4 teaspoons (25 mg to 50 mg)
children 6 to under 12 years	ask a doctor
children 4 to 5 years	do not use unless directed by a doctor
children under 4 years	do not use

Other information

STORAGE AND HANDLING SECTION

each teaspoon (5 mL) contains: sodium 5 mg
store between 20°-25°C (68°-77°F). Protect from light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial cherry flavors, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution

Questions?

OTC - QUESTIONS SECTION

call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54868-1227-0

image of package label

TAMPER-EVIDENT

Diphenhydramine HCl USP
12.5 mg per 5 mL)

ONE PINT (473 mL)

ANTIHISTAMINE

ALCOHOL-FREE
SUGAR-FREE
CHERRY-FLAVORED

TAMPER-EVIDENT: Do not use this product if
inner foil seal over the mouth of the bottle
is cut, torn, broken or missing.

NOT FOR HOUSEHOLDS
WITH YOUNG CHILDREN

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	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 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
54868-1227-0	2019-09-24	C162847	48780-1	9350213a-42c5-c013-e053-90daa90a1393	Hydramine Liquid 0182-6168-40
54868-1227-2	2019-09-24	C162847	48780-1	9350213a-42c5-c013-e053-90daa90a1393	Hydramine Liquid 0182-6168-40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54868-1227-0	Diphenhydramine Hydrochloride	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		1
54868-1227-2	Diphenhydramine Hydrochloride	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54868-1227	DIPHENHYDRAMINE HYDROCHLORIDE LIQUID [PHYSICIANS TOTAL CARE, INC.]	1	2 package rows	20120621_f8b5c38c-eb9f-4ebd-ae3d-aaea2117b2e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54868-1227-0	ML - Milliliter	54868-1227	b7ccb15d-294c-452b-8cf3-5cabfa30c183	1	2012-07-24
54868-1227-2	ML - Milliliter	54868-1227	521c7c93-4b73-43d6-9d02-08cdb913bf63	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Diphenhydramine Hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	1
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	1
D&C Red no. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
FD&C Red no. 40	INACTIVE INGREDIENT	WZB9127XOA	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	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 Hydrochloride
Diphenhydramine
citric acid monohydrate
D&C Red no. 33
FD&C Red no. 40
glycerin
polysorbate 20
water
sodium benzoate
SACCHARIN SODIUM DIHYDRATE
sodium citrate
sorbitol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54868-1227	54868-1227-0, 54868-1227-2
0182-6168

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Diphenhydramine Hydrochloride	TC2D6JAD40	ACTIM
citric acid monohydrate	2968PHW8QP	IACT
D&C Red no. 33	9DBA0SBB0L	IACT
FD&C Red no. 40	WZB9127XOA	IACT
glycerin	PDC6A3C0OX	IACT
polysorbate 20	7T1F30V5YH	IACT
water	059QF0KO0R	IACT
sodium benzoate	OJ245FE5EU	IACT
SACCHARIN SODIUM DIHYDRATE	SB8ZUX40TY	IACT
sodium citrate	1Q73Q2JULR	IACT
sorbitol	506T60A25R	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 6 · 346 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sorbitol	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOAP / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 88 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
sorbitol	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EFFERVESCENT / ORAL	460 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / NASAL	2.8 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION, CONCENTRATE / INTRAVENOUS	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EXTENDED RELEASE / ORAL		45 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 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	SYRUP / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C Red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / OPHTHALMIC	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C Red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C Red no. 40	FD&C RED NO. 40	WZB9127XOA	SHAMPOO / TOPICAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C Red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	GEL / RECTAL		406 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION, SOLUTION / INTRAMUSCULAR	4.8 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / AURICULAR (OTIC)	0.1 %w/v		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
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 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
4a3ced1f-cd7a-4b39-b0cf-63f4c7bbe4dc			f8b5c38c-eb9f-4ebd-ae3d-aaea2117b2e7	2012-06-05	Warnings	Exact identifier spl id: 4a3ced1f-cd7a-4b39-b0cf-63f4c7bbe4dc spl set id: f8b5c38c-eb9f-4ebd-ae3d-aaea2117b2e7

Reported adverse events (FAERS/openFDA)#

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