Unisom SleepMelts Nighttime Sleep-Aid

Manufacturer: Chattem, Inc.
Effective date: 2026-01-14
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 01:32:40

Label at a glance#

ProductUnisom SleepMelts Nighttime Sleep-Aid

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

for relief of occasional sleeplessness

Dosage and administration

adults and children 12 years of age and over: 2 tablets (25 mg each) at bedtime if needed, or as directed by a doctor place 2 tablets on tongue; tablets dissolve with or without water allow tablets to dissolve in mouth or chew before swallowing

Contacts and useful links#

Websitewww.chattem.com

www.chattem.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each caplet)

Diphenhydramine HCI 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

for relief of 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

a breathing problem such as emphysema or chronic bronchitis
glaucoma
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

When using this product

OTC - WHEN USING SECTION

avoid alcoholic drinks

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

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over: 2 tablets (25 mg each) at bedtime if needed, or as directed by a doctor
place 2 tablets on tongue; tablets dissolve with or without water
allow tablets to dissolve in mouth or chew before swallowing

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, ethylcellulose, flavor, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, PVP, red 7, starch, sucralose, sucrose (309-154)

Dist. by: CHATTEM, Inc.
P.O. Box 2219, Chattanooga, TN 37409 USA
© 2011 Chattem Inc. www.chattem.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unisom^®
SleepMelts^TM
Diphenhydramine HCI tablets, 25 mg
NIGHTTIME SLEEP-AID
24 Tablets

Unisom® SleepMeltsTM Diphenhydramine HCI tablets, 25 mg NIGHTTIME SLEEP-AID 24 Tablets

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1093102	UNISOM SLEEP (Oral Disintegrating)	diphenhydramine hydrochloride 25 MG Disintegrating Oral Tablet [Unisom Sleep]	SBD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1093098	diphenhydrAMINE HCl 25 MG Disintegrating Oral Tablet	PSN	10
1093102	Unisom SleepMelts 25 MG Disintegrating Oral Tablet	PSN	10
1093102	diphenhydramine hydrochloride 25 MG Disintegrating Oral Tablet [Unisom Sleep]	SBD	10
1093098	diphenhydramine hydrochloride 25 MG Disintegrating Oral Tablet	SCD	10
1093102	Unisom Sleep 25 MG Disintegrating Oral Tablet	SY	10
1093102	Unisom SleepMelts 25 MG Disintegrating Oral Tablet	SY	10

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41167-0014-0	Unisom SleepMelts Nighttime Sleep-Aid	3 in 1 CARTON	TABLET, CHEWABLE	3	10
41167-0014-0	Unisom SleepMelts Nighttime Sleep-Aid	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	10
41167-0014-1	Unisom SleepMelts Nighttime Sleep-Aid	4 in 1 CARTON	TABLET, CHEWABLE	4	10
41167-0014-1	Unisom SleepMelts Nighttime Sleep-Aid	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	4
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	4
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	4
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	4
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	4

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Unisom SleepMelts Nighttime Sleep-Aid
Diphenhydramine Hydrochloride
DIPHENHYDRAMINE
CITRIC ACID MONOHYDRATE
ETHYLCELLULOSES
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MANNITOL
CELLULOSE, MICROCRYSTALLINE
POVIDONE
D&C RED NO. 7
STARCH, CORN
SUCRALOSE
SUCROSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41167-0014	41167-0014-0, 41167-0014-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
ETHYLCELLULOSES	7Z8S9VYZ4B	IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	IACT
MANNITOL	3OWL53L36A	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	IACT
D&C RED NO. 7	ECW0LZ41X8	IACT
STARCH, CORN	O8232NY3SJ	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
SUCROSE	C151H8M554	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 2 · 78 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POVIDONES	POVIDONE	FZ989GH94E	TABLET, CHEWABLE / ORAL		48 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	POWDER / ORAL		2090 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	CAPSULE / ORAL	12.32 mg		Exact identifier — unii+route 36 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	CAPSULE, DELAYED RELEASE / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, CHEWABLE / ORAL		10 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	CAPSULE / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii+route 36 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii+route 36 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	CAPSULE / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, COATED / ORAL	20 mg		Exact identifier — unii+route 36 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	52.5 mg		Exact identifier — unii+route 36 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, CHEWABLE / ORAL		10 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, FILM COATED / ORAL	83 mg		Exact identifier — unii+route 36 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET / ORAL	0.5 mg		Exact identifier — unii+route 18 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL	0.4 mg		Exact identifier — unii+route 18 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	CAPSULE / ORAL	12.32 mg		Exact identifier — unii+route 36 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii+route 36 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET / ORAL		300 mg	Exact identifier — unii+route 36 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii+route 36 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, FILM COATED / ORAL	83 mg		Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	POWDER / ORAL		2090 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, CHEWABLE / ORAL		48 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET / ORAL		300 mg	Exact identifier — unii+route 36 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	52.5 mg		Exact identifier — unii+route 36 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, DELAYED RELEASE / ORAL	53.8 mg		Exact identifier — unii+route 36 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, FILM COATED / ORAL	83 mg		Exact identifier — unii+route 36 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, COATED / ORAL	20 mg		Exact identifier — unii+route 36 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	CAPSULE / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	CAPSULE, DELAYED RELEASE / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL	0.4 mg		Exact identifier — unii+route 18 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, COATED / ORAL	20 mg		Exact identifier — unii+route 36 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	POWDER / ORAL		2090 mg	Exact identifier — unii+route 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	CAPSULE, EXTENDED RELEASE / ORAL		153 mg	Exact identifier — unii+route 36 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	52.5 mg		Exact identifier — unii+route 36 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	CAPSULE / ORAL	12.32 mg		Exact identifier — unii+route 36 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii+route 36 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C RED NO. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL	0.4 mg		Exact identifier — unii+route 18 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii+route 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
Unisom SleepMelts Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Chattem, Inc.	9105f4f1-7f94-408d-a025-83afb68dc9f0	2026-01-14	Warnings	Exact identifier ndc (package): 41167-0014-0 ndc (package): 41167-0014-1 ndc (product): 41167-0014 ndc11 (package): 41167001400 ndc11 (package): 41167001401 spl id: 8cc87722-774c-4126-8c1c-9ff7841a67cd spl set id: 9105f4f1-7f94-408d-a025-83afb68dc9f0

Reported adverse events (FAERS/openFDA)#

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