Nighttime Sleep Aid

Manufacturer
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. | LNK International, Inc.
Effective date
2019-10-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-02 00:07:58

Label at a glance#

ProductNighttime Sleep Aid
Active ingredientDOXYLAMINE SUCCINATE
Label structure9 sections

Indications and uses

helps to reduce difficulty in falling asleep

Dosage and administration

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

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN  store at controlled room temperature 20º-25ºC (68º-77ºF) see end flap for expiration date and lot number 

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

Uses

INDICATIONS & USAGE SECTION

helps to reduce difficulty in falling asleep

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as asthma, 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 any other drugs. 

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages
  • 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 a 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: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • do not give to children under 12 years of age 

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 
  • store at controlled room temperature 20º-25ºC (68º-77ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

INACTIVE INGREDIENT SECTION

 dicalcium phosphate, 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

HEALTHCARE™
NDC 64092-350-08

Nighttime
Sleep-Aid
Doxylamine succinate 25 mg

• Go to Sleep Fast
• Safe and Effective
• Dosage: 1 Tablet

*Compare to the active ingredient in Unisom® SleepTabs®

8 TABLETS

* This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®.
50844       REV0513D38619

Distributed by:
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.
Grand Rapids, MI 49512
www.glwholesale.com

HEALTHCARE GUARANTEE
If you are not completely satisfied with this product, regardless of reason, return your unused portion to Great Lakes Wholesale for a full refund

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Healthcare 44-386Healthcare 44-386

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI22
DOXYLAMINEACTIVE MOIETY95QB77JKPL2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92J2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A22

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
64092-35064092-350-08

Ingredients#

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

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

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 · 119 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, FOR SUSPENSION / ORAL278 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / ORAL420 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JCREAM / TOPICAL36 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1576 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FOR SUSPENSION / ORAL131 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM / SUBLINGUAL0.07 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FOR SUSPENSION / ORAL20100 mgExact identifier — unii candidate
28 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, FILM COATED / ORAL1075 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / BUCCAL18 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING / ORAL1800 mgExact identifier — unii candidate
28 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JPASTILLE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, COATED PELLETS / ORAL456 mgExact identifier — unii candidate
28 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JPASTE, DENTIFRICE / DENTAL48.36 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / BUCCAL60 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, CHEWABLE / ORAL50 mgExact identifier — unii candidate
15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE PARTICLES / ORAL580 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, EXTENDED RELEASE / ORAL1246 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, FOR SUSPENSION / ORAL406 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, DELAYED RELEASE / ORAL789.6 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
37 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTROCHE / ORAL300 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UIMPLANT / INTRAVITREAL1.66 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, EXTENDED RELEASE / ORAL360 mgExact identifier — unii candidate
15 equally ranked IID candidates

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ae08af5f-565f-473f-9515-ef950bfc4f8fa1914355-2669-4010-a42a-e9ee54804f472019-10-10WarningsExact identifier
spl id: ae08af5f-565f-473f-9515-ef950bfc4f8f
spl set id: a1914355-2669-4010-a42a-e9ee54804f47

Reported adverse events (FAERS/openFDA)#

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