Allergy

Manufacturer: Velocity Pharma
Effective date: 2016-12-15
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:48:11

Label at a glance#

ProductAllergy

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose itching of the nose or throat sneezing itchy, watery eyes temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage and administration

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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-855-314-1850

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

runny nose
itching of the nose or throat
sneezing
itchy, watery eyes
temporarily relieves these symptoms due to the common cold:
runny nose
sneezing

Warnings

WARNINGS SECTION

Do not use

to make a child sleepy
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.

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

save carton for full directions and warnings
store at 25°C(77 °F) excusrsions permitted between 15°-30°C (59°-86°F)
this product contains 100.75 milligrams of calcium.
Do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carnauba Wax, Colloidal silion dioxide, croscarmellose sodium, D&C red #27 al lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80,Titanium Dioxide

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-855-314-1850

READ AND KEEP CARTON FOR COMPLETE WARNING AND INFORMATION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE TABLET, USP 25 MG

ANTIHISTAMINE

NDC:76168-013-07 36TABLETS

NDC:76168-013-12 100 TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	3
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0639277795243	GTIN-13: 0639277795243 EAN-13: 0639277795243 GTIN-12: 639277795243 UPC-A: 639277795243 GTIN storage (14 digits): 00639277795243	4abf1358-figure-02.jpg

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
76168-013-07	2020-01-31	C162847	48780-1	9d75b9d0-444d-f424-e053-dadaa90a57ce	DIPHENHYDRAMINE HCl 25mg, USP
76168-013-12	2020-01-31	C162847	48780-1	9d75b9d0-444d-f424-e053-dadaa90a57ce	DIPHENHYDRAMINE HCl 25mg, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76168-013-07	Allergy	36 in 1 BOTTLE	TABLET	36	3
76168-013-07	Allergy	1 in 1 CARTON	TABLET	1	3
76168-013-12	Allergy	1 in 1 CARTON	TABLET	1	3
76168-013-12	Allergy	100 in 1 BOTTLE	TABLET	100	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76168-013	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]	3	Legacy NDC, 4 package rows	20161215_08bff194-0ae9-4df6-a4a1-e4661c3bfad7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Allergy
Diphenhydramine Hydrochloride
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76168-013	76168-013-07, 76168-013-12

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
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
D&C RED NO. 27	2LRS185U6K	IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB

Source Document#

Source XML · Source PDF

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 · 344 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE PARTICLES / ORAL		580 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SOFT TISSUE		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii candidate 28 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
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL		330 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	INJECTION / INTRAMUSCULAR	1 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	POWDER, FOR SUSPENSION / ORAL	11.25 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	CAPSULE / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TROCHE / ORAL		315 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii candidate 4 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
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY / NASAL	0.01 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 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
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	PELLET / ORAL		162 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	SUSPENSION / ORAL		150 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	8 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, CHEWABLE / ORAL		7 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GEL / TOPICAL		12 mg	Exact identifier — unii candidate 78 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
43b59cca-632b-5ff3-e054-00144ff88e88			08bff194-0ae9-4df6-a4a1-e4661c3bfad7	2016-12-15	Warnings	Exact identifier spl id: 43b59cca-632b-5ff3-e054-00144ff88e88 spl set id: 08bff194-0ae9-4df6-a4a1-e4661c3bfad7

Reported adverse events (FAERS/openFDA)#

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