Unisom SleepMinis Nighttime Sleep-Aid

Manufacturer: Chattem, Inc.
Effective date: 2026-01-14
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:32:43

Label at a glance#

ProductUnisom SleepMinis Nighttime Sleep-Aid

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure8 sections

Dosage and administration

adults and children 12 years of age and over: 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each mini-capsule)

Diphenhydramine HCI 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use

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 persist 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 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

blue 1, citric acid, gelatin, lactose, polysorbate 80, potassium sorbate, pregelatinized corn starch, red 3, titanium dioxide (309-121)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unisom
#1 Pharmacist Recommended Ingredient*
SleepMinis
Diphenhydramine HCI
Mini-Capsules, 25 mg
NIGHTTIME SLEEP-AID
60 Mini-Capsules

Unisom #1 Pharmacist Recommended Ingredient* SleepMinis Diphenhydramine HCI Mini-Capsules, 25 mg NIGHTTIME SLEEP-AID 60 Mini-Capsules

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	8
1648369	Unisom SleepMinis 25 MG Oral Capsule	PSN	8
1648369	diphenhydramine hydrochloride 25 MG Oral Capsule [Unisom Sleep]	SBD	8
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	8
1648369	Unisom Sleep 25 MG Oral Capsule	SY	8

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
41167-0067-0	Unisom SleepMinis Nighttime Sleep-Aid	1 in 1 CARTON	CAPSULE	1	8
41167-0067-0	Unisom SleepMinis Nighttime Sleep-Aid	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	8
41167-0067-2	Unisom SleepMinis Nighttime Sleep-Aid	1 in 1 CARTON	CAPSULE	1	8
41167-0067-2	Unisom SleepMinis Nighttime Sleep-Aid	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	8

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
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2

Products#

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

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

Unisom SleepMinis Nighttime Sleep-Aid
Diphenhydramine HCl
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
FD&C BLUE NO. 1
ANHYDROUS CITRIC ACID
GELATIN
LACTOSE MONOHYDRATE
POLYSORBATE 80
POTASSIUM SORBATE
STARCH, CORN
FD&C RED NO. 3
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41167-0067	41167-0067-2, 41167-0067-0

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
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GELATIN	2G86QN327L	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
STARCH, CORN	O8232NY3SJ	IACT
FD&C RED NO. 3	PN2ZH5LOQY	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 1 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL		10932 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL		10932 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL		10932 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii+route+dosage form 3 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 SleepMinis Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	Chattem, Inc.	a9a44c2f-65eb-4a5a-9e72-43652dce57f7	2026-01-14	Warnings	Exact identifier ndc (package): 41167-0067-2 ndc (package): 41167-0067-0 ndc (product): 41167-0067 ndc11 (package): 41167006700 ndc11 (package): 41167006702 spl id: 2bf9a980-5845-44ff-aad4-1dbcfd67f6eb spl set id: a9a44c2f-65eb-4a5a-9e72-43652dce57f7

Reported adverse events (FAERS/openFDA)#

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