DIPHENHYDRAMINE HYDROCHLORIDE

Manufacturer: DIRECT RX
Effective date: 2015-08-27
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:43:25

Label at a glance#

ProductDIPHENHYDRAMINE HYDROCHLORIDE

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

(in each capsule)

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Antihistamine

INSTRUCTIONS FOR USE SECTION

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
runny nose
itchy nose or throat
sneezing
itchy, watery eyes

WARNINGS SECTION

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product
you may get very drowsy
avoid alcoholic drinks
alcohol, sedatives & tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

store at 15-30 °C (59-86 °F)
protect from moisture
For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP

INACTIVE INGREDIENT SECTION

benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate

OTC - QUESTIONS SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

Distributed by: Qualitest Pharmaceuticals, Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	3
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	3

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
61919-078-20	2020-01-31	C162847	48780-1	9d75b9d0-fd8d-f424-e053-dadaa90a57ce	DIPHENHYDRAMINE HYDROCHLORIDE
61919-078-30	2020-01-31	C162847	48780-1	9d75b9d0-fd8d-f424-e053-dadaa90a57ce	DIPHENHYDRAMINE HYDROCHLORIDE
61919-078-90	2020-01-31	C162847	48780-1	9d75b9d0-fd8d-f424-e053-dadaa90a57ce	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-078-20	DIPHENHYDRAMINE HYDROCHLORIDE	20 in 1 BOTTLE	CAPSULE	20	3
61919-078-30	DIPHENHYDRAMINE HYDROCHLORIDE	30 in 1 BOTTLE	CAPSULE	30	3
61919-078-90	DIPHENHYDRAMINE HYDROCHLORIDE	90 in 1 BOTTLE	CAPSULE	90	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-078	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]	3	Legacy NDC, 3 package rows	20150827_d2d07121-66f2-4726-acd5-6e8c33d91024.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-078-30	EA - Each	61919-078	0cbd346b-fe5b-487b-aaa2-e36ddfb541bb	1	2015-09-10
61919-078-90	EA - Each	61919-078	fc642b34-0b34-409c-ba87-129342f576a6	1	2015-10-02
0603-3339-21	EA - Each	0603-3339	e2c93408-9328-4e7c-a395-f51f58d99251	1	2013-02-13
0603-3339-32	EA - Each	0603-3339	4b90952e-b661-4a90-9202-84b5a29a00ca	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	3
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	3
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	3

Products#

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

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

DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
BENZYL ALCOHOL
BUTYLPARABEN
D&C RED NO. 28
FD&C BLUE NO. 1
GELATIN
LACTOSE
MAGNESIUM STEARATE
METHYLPARABEN
POLYSORBATE 80
PROPYLPARABEN
SODIUM LAURYL SULFATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61919-078	61919-078-20, 61919-078-90, 61919-078-30
0603-3339

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
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
BENZYL ALCOHOL	LKG8494WBH	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
D&C RED NO. 28	767IP0Y5NH	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
LACTOSE	J2B2A4N98G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM LAURYL SULFATE	368GB5141J	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 9 · 499 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / BUCCAL	5.18 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL		13 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / ORAL		360 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE, EXTENDED RELEASE / ORAL	1.23 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / ORAL		6 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SPONGE / TOPICAL	5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRAMUSCULAR		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRA-ARTICULAR		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EXTENDED RELEASE / ORAL		320 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET / ORAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER / RESPIRATORY (INHALATION)	100 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET / PERIODONTAL	3.44 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / SUBCUTANEOUS	0.95 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRA-ARTICULAR		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAMUSCULAR		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PARENTERAL		18 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 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
cd824743-f26e-4da4-a217-19a409f4da09			d2d07121-66f2-4726-acd5-6e8c33d91024	2015-08-27	Warnings	Exact identifier spl id: cd824743-f26e-4da4-a217-19a409f4da09 spl set id: d2d07121-66f2-4726-acd5-6e8c33d91024

Reported adverse events (FAERS/openFDA)#

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