Drug Facts

Manufacturer: Care One (American Sales Company)
Effective date: 2026-04-27
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:55:09

Label at a glance#

ProductNighttime Sleep Aid

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

take only one dose per day (24 hours) - (see overdose warning) mL=milliliter measure only with dosing cup provided.Do not use any other dosing device keep dosing cup with product adults and children 12 years and over one dose=30 mL at bedtime if needed, or as directed by a doctor children under 12 years do not use

Contacts and useful links#

PhoneLabel contact1-877-753-3935

PhoneLabel contact1-877-846-9949

Label contents#

Full prescribing information#

Active ingredient (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

with any other product containing diphenhydramine, even one used on the skin
for children under 12 years of age
with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

heart disease
glaucoma
breathing problem such as asthma,emphysema, or chronic bronchitis
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers or any other sleep-aid.

When using this product

OTC - WHEN USING SECTION

drowsiness will occur
avoid alcoholic drinks and other drugs that cause drowsiness
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

take only one dose per day (24 hours) - (see overdose warning)
mL=milliliter
measure only with dosing cup provided.Do not use any other dosing device
keep dosing cup with product
adults and children 12 years and over
- one dose=30 mL at bedtime if needed, or as directed by a doctor
children under 12 years do not use

Other information

SPL UNCLASSIFIED SECTION

each 30 mL contains: sodium 23 mg
store at 20-25ºC (68-77ºF)
do not refrigerate
protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium , sodium benzoate, trisodium citrate dihydrate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredient in ZZZQUIL®*

NIGHTTIME SLEEP AID

Diphenhydramine HCI 50 mg

Alcohol 10%

Non-Habit-Forming

Not for treating cold or flu

Berry Flavor

FL OZ (mL)

Failure to follow these warnings could result in serious consequences

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

DISTRIBUTED BY

FOODHOLD USA LLC

LANDOVER, MD 20785

1-877-846-9949

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1248354	diphenhydrAMINE HCl 50 MG in 30 mL Oral Solution	PSN	7
1248354	diphenhydramine hydrochloride 1.67 MG/ML Oral Solution	SCD	7
1248354	diphenhydramine HCl 1.667 MG/ML Oral Solution	SY	7
1248354	diphenhydramine HCl 50 MG per 30 ML Oral Solution	SY	7

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	0341520001680	GTIN-13: 0341520001680 EAN-13: 0341520001680 GTIN-12: 341520001680 UPC-A: 341520001680 GTIN storage (14 digits): 00341520001680	ez-nite-sleep-aid-liquid-delisted-1.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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41520-034-06	Nighttime Sleep Aid	177 mL in 1 BOTTLE, PLASTIC	LIQUID	177		7
41520-034-12	Nighttime Sleep Aid	355 mL in 1 BOTTLE, PLASTIC	LIQUID	355		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SACCHARIN SODIUM ANHYDROUS	INACTIVE INGREDIENT	I4807BK602	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Nighttime Sleep Aid
Diphenhydramine HCl
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
ANHYDROUS CITRIC ACID
PROPYLENE GLYCOL
POLYOXYL 40 STEARATE TYPE I
WATER
SODIUM BENZOATE
SACCHARIN SODIUM ANHYDROUS
TRISODIUM CITRATE DIHYDRATE
HIGH FRUCTOSE CORN SYRUP
FD&C BLUE NO. 1
ALCOHOL
FD&C RED NO. 40

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41520-034	41520-034-06, 41520-034-12

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
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM ANHYDROUS	I4807BK602	IACT
TRISODIUM CITRATE DIHYDRATE	B22547B95K	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
ALCOHOL	3K9958V90M	IACT
FD&C RED NO. 40	WZB9127XOA	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 · 264 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	ELIXIR / ORAL		120 mg	Exact identifier — unii+route 42 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii+route 66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	TABLET / ORAL		896 mg	Exact identifier — unii+route 42 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE / ORAL		131 mg	Exact identifier — unii+route 66 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii+route 57 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	POWDER, FOR SUSPENSION / ORAL		5010 mg	Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route 57 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii+route 66 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / ORAL		46 mg	Exact identifier — unii+route 66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii+route 42 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route 66 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 66 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SOLUTION / ORAL		10000 mg	Exact identifier — unii+route 9 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii+route 66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	TABLET, DELAYED RELEASE / ORAL		640 mg	Exact identifier — unii+route 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route 57 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route 66 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / ORAL		84 mg	Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route 66 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / ORAL		3900 mg	Exact identifier — unii+route 66 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EXTENDED RELEASE / ORAL		312 mg	Exact identifier — unii+route 66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	CONCENTRATE / ORAL		104 mg	Exact identifier — unii+route 42 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii+route 66 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	CAPSULE / ORAL		14 mg	Exact identifier — unii+route 12 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	TABLET, DELAYED RELEASE / ORAL		640 mg	Exact identifier — unii+route 42 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	TABLET / ORAL	8.48 mg		Exact identifier — unii+route 12 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SOLUTION / ORAL		123 mg	Exact identifier — unii+route 66 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SUSPENSION / ORAL		570 mg	Exact identifier — unii+route 66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	ELIXIR / ORAL		120 mg	Exact identifier — unii+route 42 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii+route 66 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	LIQUID / INTRAVENOUS		18 mg	Exact identifier — unii+dosage form 66 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	PASTE / ORAL		26 mg	Exact identifier — unii+route 66 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii+route 57 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	PASTE / ORAL		26 mg	Exact identifier — unii+route 66 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+route 66 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	CAPSULE / ORAL		14 mg	Exact identifier — unii+route 12 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route 57 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii+route 42 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	GRANULE, FOR SUSPENSION / ORAL		30 mg	Exact identifier — unii+route 66 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii+route 57 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	ELIXIR / ORAL		90 mg	Exact identifier — unii+route 66 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	GRANULE / ORAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		48 mg	Exact identifier — unii+route 66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SOLUTION / ORAL		1200 mg	Exact identifier — unii+route 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route 57 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii+route 57 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 66 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATE	TRISODIUM CITRATE DIHYDRATE	B22547B95K	SOLUTION / ORAL		1200 mg	Exact identifier — unii+route 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route 57 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii+route 66 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	ELIXIR / ORAL	12.5 mg/5ml		Exact identifier — unii+route 66 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii+route 66 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION, EXTENDED RELEASE / ORAL		3000 mg	Exact identifier — unii+route 9 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
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Care One (American Sales Company)	bd5de3b3-7cb5-4403-b664-23ac70b9957f	2026-04-27	Warnings	Exact identifier ndc (package): 41520-034-12 ndc (package): 41520-034-06 ndc (product): 41520-034 ndc11 (package): 41520003406 ndc11 (package): 41520003412 spl id: dc496e69-0bf8-4215-ac37-4f7256115d90 spl set id: bd5de3b3-7cb5-4403-b664-23ac70b9957f

Reported adverse events (FAERS/openFDA)#

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