Diphenhydramine Hydrochloride Soft Gelatin Capsules

Manufacturer: SPIRIT PHARMACEUTICALS,LLC
Effective date: 2010-07-26
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:25:29

Label at a glance#

ProductDIPHENHYDRAMINE HYDROCHLORIDE

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

For relief occasional sleeplessness

Contacts and useful links#

PhoneLabel contact215 943 4000

PhoneLabel contact215 943 4039

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each LiquiCap)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime Sleep aid

Uses

INDICATIONS & USAGE SECTION

For relief occasional sleeplessness

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

for children under 12 years of age
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 enlarged postage 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.

OTC - WHEN USING SECTION

When using this product avoid alcoholic drinks

Stop use and ask doctor if

OTC - STOP USE SECTION

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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.

Direction

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older -1 softgel (50mg) at bedtime if needed; or as directed by doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

PEG – 400, Propylene Glycol USP , Gelatin , Sorbitol, FD & C Blue No.1 IH, Purified water

PRINCIPAL DISPLAY PANEL - 50 mg Shipper Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine Hydrochloride Soft Gelatin Capsules

Each soft gelatin capsule contains:
Diphenhydramine Hydrochloride USP 50 mg

LOT NO :

MFG DATE :

EXP. DATE :

NDC NO : 68210-1510-4

QUANTITY : 1000 × 4 Capsules

GROSS WT. :

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS BULK SHIPMENT IS INTENDED FOR FURTHER PACKAGING PROCESS ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FD & C ACT AND REGULATIONS THEREUNDER.

MANUFACTURED BY:
Marksans Pharma Ltd
VERNA, GOA-403722,
INDIA.
CODE : GO/DRUGS/515

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

OLIL058

PRINCIPAL DISPLAY PANEL - 50 mg Shipper Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	2
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	2
1020477	diphenhydramine HCl 50 MG Oral Capsule	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68210-1510-1	2019-10-21	C162847	48780-1	956f9ecf-d11f-621f-e053-dbdaa90a74ad	Diphenhydramine Hydrochloride Soft Gelatin Capsules
68210-1510-4	2019-10-21	C162847	48780-1	956f9ecf-d11f-621f-e053-dbdaa90a74ad	Diphenhydramine Hydrochloride Soft Gelatin Capsules
68210-1510-6	2019-10-21	C162847	48780-1	956f9ecf-d11f-621f-e053-dbdaa90a74ad	Diphenhydramine Hydrochloride Soft Gelatin Capsules
68210-1510-8	2019-10-21	C162847	48780-1	956f9ecf-d11f-621f-e053-dbdaa90a74ad	Diphenhydramine Hydrochloride Soft Gelatin Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68210-1510-1	DIPHENHYDRAMINE HYDROCHLORIDE	10000 in 1 BAG	CAPSULE, LIQUID FILLED	10000	2
68210-1510-1	DIPHENHYDRAMINE HYDROCHLORIDE	1 in 1 DRUM	CAPSULE, LIQUID FILLED	1	2
68210-1510-4	DIPHENHYDRAMINE HYDROCHLORIDE	1 in 1 DRUM	CAPSULE, LIQUID FILLED	1	2
68210-1510-4	DIPHENHYDRAMINE HYDROCHLORIDE	4000 in 1 BAG	CAPSULE, LIQUID FILLED	4000	2
68210-1510-6	DIPHENHYDRAMINE HYDROCHLORIDE	6000 in 1 BAG	CAPSULE, LIQUID FILLED	6000	2
68210-1510-6	DIPHENHYDRAMINE HYDROCHLORIDE	1 in 1 DRUM	CAPSULE, LIQUID FILLED	1	2
68210-1510-8	DIPHENHYDRAMINE HYDROCHLORIDE	8000 in 1 BAG	CAPSULE, LIQUID FILLED	8000	2
68210-1510-8	DIPHENHYDRAMINE HYDROCHLORIDE	1 in 1 DRUM	CAPSULE, LIQUID FILLED	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-1510	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	2	Legacy NDC, 8 package rows	20100810_01ba06dd-fe81-465b-ad53-cdccde45f8e2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
GELATIN
SORBITOL
WATER
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68210-1510	68210-1510-4, 68210-1510-6, 68210-1510-8, 68210-1510-1

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
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
GELATIN	2G86QN327L	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
FD&C BLUE NO. 1	H3R47K3TBD	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 · 242 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GELATIN	GELATIN	2G86QN327L	SOLUTION / ORAL	34.8 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 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
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, COATED PELLETS / ORAL	65 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / TOPICAL		11100 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SWAB / TOPICAL		5250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION/ DROPS / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL		13440 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SOLUTION / INTRAVENOUS	34.8 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, DELAYED RELEASE / ORAL	19 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	PASTE / DENTAL		252 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / ORAL		120 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, FILM COATED / ORAL		57 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	DROPS / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 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
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	AEROSOL, POWDER / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	WAFER / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPRAY, METERED / NASAL		320 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	GUM, CHEWING / BUCCAL		102 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii candidate 36 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
76d8de20-70b3-4727-9dea-d31d1b1e970d			01ba06dd-fe81-465b-ad53-cdccde45f8e2	2010-07-26	Warnings	Exact identifier spl id: 76d8de20-70b3-4727-9dea-d31d1b1e970d spl set id: 01ba06dd-fe81-465b-ad53-cdccde45f8e2

Reported adverse events (FAERS/openFDA)#

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