Sleep Aid

Manufacturer: Walgreen Company | LNK International, Inc.
Effective date: 2026-02-11
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:44:00

Label at a glance#

ProductSleep Aid

Active ingredientDOXYLAMINE SUCCINATE

Label structure9 sections

Dosage and administration

adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use

Storage and handling

store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number

Contacts and useful links#

PhoneLabel contact1-800-426-9391

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Doxylamine succinate 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

helps to reduce difficulty in falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

in children under 12 years of age
with any other product containing doxylamine
unless you have time for a full night’s sleep

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking

any other drugs
sedatives or any other sleep-aid
any other antihistamines
tranquilizers

When using this product

OTC - WHEN USING SECTION

avoid alcoholic beverages
do not drive a motor vehicle or operate machinery
take only at bedtime

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuously for more than two 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: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

store at controlled room temperature 20°-25°C (68°-77°F)
see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE SIZE

Walgreens

WALGREENS PHARMACIST RECOMMENDED^†

Compare to the active ingredient
in Unisom® SleepTabs®^††

Sleep Aid
DOXYLAMINE SUCCINATE TABLETS,
25 mg / NIGHTTIME SLEEP-AID
Nighttime

80
TABLETS

ONE TABLET PER DOSE

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER CAP IS
BROKEN OR MISSING

^†Our pharmacists recommend the
Walgreens brand. We invite you to
compare to national brands.
^††This product is not manufactured
or distributed by Chattem, Inc.,
owner of the registered trademark
Unisom® SleepTabs®.

DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2023 Walgreen Co.

50844 ORG012338631

NDC 0363-0386-31

WALGREENS 44-386

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1101446	doxylamine succinate 25 MG Oral Tablet	PSN	5
1101446	doxylamine succinate 25 MG Oral Tablet	SCD	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DOXYLAMINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0311917045139	GTIN-13: 0311917045139 EAN-13: 0311917045139 GTIN-12: 311917045139 UPC-A: 311917045139 GTIN storage (14 digits): 00311917045139	walgreens-44-386-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0386-12	Sleep Aid	1 in 1 CARTON	TABLET	1	5
0363-0386-12	Sleep Aid	100 in 1 BOTTLE, PLASTIC	TABLET	100	5
0363-0386-22	Sleep Aid	16 in 1 BLISTER PACK	TABLET	16	5
0363-0386-22	Sleep Aid	3 in 1 CARTON	TABLET	3	5
0363-0386-31	Sleep Aid	80 in 1 BOTTLE, PLASTIC	TABLET	80	5
0363-0386-31	Sleep Aid	1 in 1 CARTON	TABLET	1	5

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Sleep Aid
Doxylamine succinate
DOXYLAMINE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 1 ALUMINUM LAKE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-0386	0363-0386-22, 0363-0386-31, 0363-0386-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DOXYLAMINE SUCCINATE	V9BI9B5YI2	ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	IACT
FD&C BLUE NO. 1 ALUMINUM LAKE	J9EQA3S2JM	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040564-001	DOXYLAMINE SUCCINATE	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL			2004-08-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`3a93d1ddd44b…`

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
Sleep Aid	DOXYLAMINE SUCCINATE	Walgreen Company	d812217b-b2f2-4716-92f4-c16bd0768e17	2026-02-11	Warnings	Exact identifier ndc (package): 0363-0386-31 ndc (package): 0363-0386-22 ndc (package): 0363-0386-12 ndc (product): 0363-0386 ndc11 (package): 00363038612 ndc11 (package): 00363038622 ndc11 (package): 00363038631 spl id: d1c23648-ab41-4db2-aaf2-d0f3fabd0aa2 spl set id: d812217b-b2f2-4716-92f4-c16bd0768e17

Reported adverse events (FAERS/openFDA)#

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