DIPHENHYDRAMINE HCl CAPSULES

Manufacturer: PURINEPHARMA LLC
Effective date: 2014-08-14
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 22:39:57

Label at a glance#

ProductDIPHENHYDRAMINE

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure13 sections

Storage and handling

Other information Store between 15-30 degree Celsius (59-86 degree Fahrenheit) Protect from moisture

Contacts and useful links#

Websitewww.purinepharma.com

www.purinepharma.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (each banded capsule contains)
Diphenhydramine HCL 25 mg

OTC - PURPOSE SECTION

Purpose
Antihistaminne

INDICATIONS & USAGE SECTION

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 SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

a breathing problem such as chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

OTC - DO NOT USE SECTION

Do not use to make a child sleepy

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

OTC - WHEN USING SECTION

When using this product

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 reach of children, In case of overdose, get medical help or contact a Poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

Take every 4 to 6 hours.
Do not take more than 6 doses in any 24-hour period.

Adults and Children 12 years of age and over	1 to 2 capsules
Children 6 to under 12 years of age	1 capsule
Children under 6 years of age	Do not use

STORAGE AND HANDLING SECTION

Other information

Store between 15-30 degree Celsius (59-86 degree Fahrenheit)
Protect from moisture

INACTIVE INGREDIENT SECTION

D&C red 28, gelatin, lactose monohydrate, magnesium stearate, maize starch, polysorbate tween 80, silica gel.

HOW SUPPLIED SECTION

Pack Size: 50 Capsules in a Bottle
Batch No.:
Mfg. Date:
Exp. Date:

OTHER SAFETY INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58599-003-90
NDC 58599-003-25
NDC 58599-003-29
NDC 58599-003-35

Manufactured By: PURINEPHARMA LLC
5 County Route 42
Massena, NY – 13662
www.purinepharma.com

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	5
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	5

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
58599-003-25	2019-11-27	C162847	48780-1	9855e2a2-4b87-60a7-e053-dbdaa90a05bd	DIPHENHYDRAMINE HCl CAPSULES
58599-003-29	2019-11-27	C162847	48780-1	9855e2a2-4b87-60a7-e053-dbdaa90a05bd	DIPHENHYDRAMINE HCl CAPSULES
58599-003-35	2019-11-27	C162847	48780-1	9855e2a2-4b87-60a7-e053-dbdaa90a05bd	DIPHENHYDRAMINE HCl CAPSULES
58599-003-90	2019-11-27	C162847	48780-1	9855e2a2-4b87-60a7-e053-dbdaa90a05bd	DIPHENHYDRAMINE HCl CAPSULES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58599-003-25	DIPHENHYDRAMINE	1 in 1 CARTON	CAPSULE	1	5
58599-003-25	DIPHENHYDRAMINE	50 in 1 BOTTLE	CAPSULE	50	5
58599-003-29	DIPHENHYDRAMINE	1 in 1 CARTON	CAPSULE	1	5
58599-003-29	DIPHENHYDRAMINE	100 in 1 BOTTLE	CAPSULE	100	5
58599-003-35	DIPHENHYDRAMINE	1 in 1 CARTON	CAPSULE	1	5
58599-003-35	DIPHENHYDRAMINE	1000 in 1 BOTTLE	CAPSULE	1000	5
58599-003-90	DIPHENHYDRAMINE	50000 in 1 BOX	CAPSULE	50000	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58599-003	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [PURINEPHARMA LLC]	5	Legacy NDC, 7 package rows	20140815_d72be275-850f-420c-aa68-66cbfcf87160.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	5
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	5
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	5

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

DIPHENHYDRAMINE
DIPHENHYDRAMINE HYDROCHLORIDE
D&C RED NO. 28
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
POLYSORBATE 80

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58599-003	58599-003-90, 58599-003-25, 58599-003-29, 58599-003-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
D&C RED NO. 28	767IP0Y5NH	IACT
GELATIN	2G86QN327L	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
STARCH, CORN	O8232NY3SJ	IACT
POLYSORBATE 80	6OZP39ZG8H	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 4 · 232 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GELATIN	GELATIN	2G86QN327L	CAPSULE, LIQUID FILLED / ORAL		1042 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ENEMA / RECTAL	0.01 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, FILM COATED / ORAL		57 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	POWDER, FOR SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION, EXTENDED RELEASE / ORAL		113 mg	Exact identifier — unii candidate 22 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
GELATIN	GELATIN	2G86QN327L	TABLET, EXTENDED RELEASE / ORAL		239 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET / ORAL		46 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / TOPICAL	0.98 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, EXTENDED RELEASE / ORAL		2575 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 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
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	AEROSOL / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVENOUS	0.5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / INTRACAVITARY	0.05 ml		Exact identifier — unii candidate 44 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
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / BUCCAL		43 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	WAFER / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL		13 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, ORALLY DISINTEGRATING / ORAL		366 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	53 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SOFT TISSUE		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, SUSPENSION / INTRAMUSCULAR	1.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		4739 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / RECTAL	72.15 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / AURICULAR (OTIC)		13 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS		174 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER / ORAL	100 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	POWDER / RESPIRATORY (INHALATION)		25 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	107 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	DROPS / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / INTRAMUSCULAR		150 mg	Exact identifier — unii candidate 38 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
0c90365e-c06d-4368-b627-aac3c415ddd2			d72be275-850f-420c-aa68-66cbfcf87160	2014-08-14	Warnings	Exact identifier spl id: 0c90365e-c06d-4368-b627-aac3c415ddd2 spl set id: d72be275-850f-420c-aa68-66cbfcf87160

Reported adverse events (FAERS/openFDA)#

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