ZzzQuil

Manufacturer: The Procter & Gamble Manufacturing Company
Effective date: 2023-02-09
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-01 21:36:59

Label at a glance#

ProductZzzQuil Alcohol Free Nighttime Sleep-Aid

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure11 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) only use the dose cup provided adults & children 12 yrs & over 30 mL at bed time if needed or as directed by a doctor children under 12 yrs do not use

Storage and handling

each 30 mL contains: sodium 24 mg store at controlled room temperature

Contacts and useful links#

PhoneLabel contact1-877-881-5813

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL dose cup)

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

OTC - DO NOT USE SECTION

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

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 beverages

OTC - STOP USE SECTION

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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.

Directions

DOSAGE & ADMINISTRATION SECTION

take only one dose per day (24 hours)
only use the dose cup provided
adults & children 12 yrs & over 30 mL at bed time if needed or as directed by a doctor
children under 12 yrs do not use

Other information

STORAGE AND HANDLING SECTION

each 30 mL contains:

sodium 24 mg
store at controlled room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, FD&C Blue No. 1, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-877-881-5813

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

From the makers of VICKS ^® NyQuil™

ZzzQuil™

ALCOHOL FREE

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

Non-Habit Forming

Soothing Mango Berry

Not for treating Cold or Flu

12 FL OZ (354 ml)

431 NEW

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37000-431-06	ML - Milliliter	37000-431	621e0e0c-2e18-4346-89c1-b3afb0ed2d08	1	2015-09-10
37000-431-12	ML - Milliliter	37000-431	5e43ff80-4241-46cf-8e1e-b85e94f53e74	1	2015-09-10
37000-431-24	ML - Milliliter	37000-431	9b0701c6-0971-4af4-8d08-a4ed8936017b	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Diphenhydramine Hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	1
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	1
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
high fructose corn syrup	INACTIVE INGREDIENT	XY6UN3QB6S	1
polyoxyl 40 stearate	INACTIVE INGREDIENT	13A4J4NH9I	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

ZzzQuil Alcohol Free Nighttime Sleep-Aid
Diphenhydramine Hydrochloride
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
HIGH FRUCTOSE CORN SYRUP
POLYOXYL 40 STEARATE
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
SODIUM CITRATE
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37000-431	37000-431-06, 37000-431-12, 37000-431-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
POLYOXYL 40 STEARATE	13A4J4NH9I	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB

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
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM, SOLUBLE / ORAL		7 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION, SOLUTION / INTRAMUSCULAR	4.8 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / SUBLINGUAL		36 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 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
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / INTRAMUSCULAR		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
polyoxyl 40 stearate	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	CREAM / TOPICAL		86000 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / OPHTHALMIC	0.09 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 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
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	AEROSOL / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 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
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / RECTAL	0.01 %w/v		Exact identifier — unii candidate 37 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EFFERVESCENT / ORAL		840 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
polyoxyl 40 stearate	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	OINTMENT / OPHTHALMIC	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		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	FILM / SUBLINGUAL	0.07 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
polyoxyl 40 stearate	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION, EMULSION / INTRAVENOUS	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
polyoxyl 40 stearate	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	SOLUTION / OPHTHALMIC	7 %w/w		Exact identifier — unii candidate 13 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	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	GRANULE, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 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
high fructose corn syrup	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION / ORAL		20000 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / PERINEURAL	0.02 %w/v		Exact identifier — unii candidate 61 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
fe304bc1-e74a-d206-e053-6294a90a0930			7b0cc06d-c1bd-415b-953f-6f89adbb2e59	2023-06-15	Warnings	Exact identifier spl set id: 7b0cc06d-c1bd-415b-953f-6f89adbb2e59

Reported adverse events (FAERS/openFDA)#

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

adults & children 12 yrs & over	30 mL at bed time if needed or as directed by a doctor
children under 12 yrs	do not use

ZzzQuil

Label at a glance#

Indications and uses

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Active ingredient (in each 30 mL dose cup)

Purpose

Uses

Warnings

OTC - DO NOT USE SECTION

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - WHEN USING SECTION

OTC - STOP USE SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

Related RxNorm Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#