FDA.reportPublic FDA data

Drug Facts

Manufacturer
Bi-Mart
Effective date
2026-10-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-07 01:02:58

Label at a glance#

ProductNighttime Sleep 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 between 20° to 25°C (68° to 77°F) protect from excessive moisture DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

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

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

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 (1-800-222-1222) 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 between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-844-912-4012

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

11

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37835-83137835-831-48

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
NameUNIIKind
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040564-001DOXYLAMINE SUCCINATEDOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2784e616aacf4f…
2026-08-18 06:07:402026-07A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-273f01610625f2…
2019-09-15 20:21 UTC2019-09A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27f41ea6bd6efb…

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 5 · 94 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SLEEP AIDDOXYLAMINE SUCCINATEAmazon.com Services LLCc4509e0a-cb9d-454c-a67b-812a0ba62be12026-09-02WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATECOSTCO WHOLESALE CORPORATION74a728e1-9ca1-4219-9427-b503ab0480b42026-08-28WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEKroger514aa6b5-c33b-494c-e063-6294a90a7ace2026-08-27WarningsName fallback
brand name: Nighttime Sleep Aid
ultra sleep aidDOXYLAMINE SUCCINATEWalgreen Company90a5986d-2555-4c2d-8e41-16537ff1aa362026-08-19WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp8db277e2-9d98-40b6-8000-a51c57fb4ece2026-08-14WarningsName fallback
brand name: Nighttime Sleep Aid
nighttime sleep aidDIPHENHYDRAMINE HCLAmazon.com Services LLCa8056e5f-e9d8-4555-9212-bf1fa3c154392026-07-16WarningsName fallback
brand name: nighttime sleep aid
Nighttime Sleep AidDOXYLAMINE SUCCINATEH E B17667c28-b61e-4974-8736-5de59f69b3b02026-07-09WarningsName fallback
brand name: Nighttime Sleep Aid
generic name: DOXYLAMINE SUCCINATE
Sleep-AidDOXYLAMINE SUCCINATECardinal Health 110, LLC. DBA Leader96e8d6df-e717-4ffc-9502-498024c9665f2026-07-09WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nocto Sleep AidDOXYLAMINE SUCCINATEBelmora LLCd255309b-0023-48fe-890f-6a4fe04dbb852026-07-09WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDIPHENHYDRAMINE HCL 25 MGHealth Pharma USA LLCd659f747-9790-8bd6-e053-2995a90ae7932026-07-07WarningsName fallback
brand name: Nighttime Sleep Aid
Nighttime Sleep AidACETAMINOPHEN, DIPHENHYDRAMINEHi-Tech Nutraceuticals, LLCa39e2bd6-3d0a-642b-e053-2995a90a42a02026-07-06WarningsName fallback
brand name: Nighttime Sleep Aid
Nighttime Sleep AidDIPHENHYDRAMINE HCLCVS Pharmacy3710254e-6c3c-4044-9694-59703274cd0f2026-06-15WarningsName fallback
brand name: Nighttime Sleep Aid
Nighttime Sleep AidDOXYLAMINE SUCCINATEAmerisource Bergenea842bc4-9788-49a9-a7e1-d6e3dd61056a2026-06-15WarningsName fallback
brand name: Nighttime Sleep Aid
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED6d6e47df-a965-4813-8414-9841ed2f9e0c2026-06-15WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDIPHENHYDRAMINE HCLFamily Dollar Services Inc2d63400b-43ae-4dd2-b917-3f65e02366b42026-06-08WarningsName fallback
brand name: Nighttime Sleep Aid
sleep aidDOXYLAMINE SUCCINATERite Aid Corporation4b5fdb06-f205-4424-b4cb-dddef921485b2026-05-27WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDIPHENHYDRAMINE HCLTOPCO ASSOCIATES LLC9558cc42-d27d-42af-b0a7-44cad025165d2026-05-21WarningsName fallback
brand name: Nighttime Sleep Aid
Sleep AidDOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE009df4c9-a524-4b8f-be7a-52c521e68ff12026-05-18WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATEStrategic Sourcing Services LLCeddec8bc-2bed-4bc5-a1c2-39424a6998382026-05-13WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATEWal-Mart Stores Inc71e0cef1-6195-4b67-9c1f-b4e5fbeae53c2026-05-13WarningsName fallback
generic name: DOXYLAMINE SUCCINATE

Reported adverse events (FAERS/openFDA)#

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