Sleep-Aid

Manufacturer
H E B | LNK International, Inc.
Effective date
2018-01-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:03:59

Label at a glance#

ProductSleep-Aid
Active ingredientDOXYLAMINE SUCCINATE
Label structure9 sections

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

Use

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

  • glaucoma
  • a breathing problem such as asthma, emphysema or chronic bronchitis
  • 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

Compare to Unisom® SleepTabs® active ingredient*

NDC 37808-386-27

H - E - B ®

S L E E P  -  A I D
Doxylamine Succinate Tablets, 25 mg

NIghttime Sleep-Aid
• Proven Effective
• Just One Tablet Per Dose

Does Not Contain Gluten

ACTUAL SIZE

32 Tablets

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®.
50844    REV0513A38627     1309

MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204

GUARANTEE
We believe the high quality of this H-E-B® product makes it an outstanding value. We hope you'll agree. If not, we'll cheerfully refund your money. Thanks for shopping with us.

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

HEB 44-386HEB 44-386

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041220947454GTIN-13: 0041220947454
EAN-13: 0041220947454
GTIN-12: 041220947454
UPC-A: 041220947454
GTIN storage (14 digits): 00041220947454
heb-44-386-delisted-1.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI21
DOXYLAMINEACTIVE MOIETY95QB77JKPL1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92J1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A21

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-38637808-386-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, CHEWABLE / ORAL50 mgExact identifier — unii candidate
15 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
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii candidate
37 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 PHOSPHATEL11K75P92JCAPSULE, EXTENDED RELEASE / ORAL301.7 mgExact identifier — unii candidate
15 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 STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / ORAL2240 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii candidate
28 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
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. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, COATED PELLETS / ORAL456 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JPOWDER / SUBLINGUAL30 mgExact identifier — unii candidate
15 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
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / ORAL420 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact 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 STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii candidate
28 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JCREAM / TOPICAL36 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact 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. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
37 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, DELAYED RELEASE / ORAL366 mgExact identifier — unii candidate
28 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, EXTENDED RELEASE / ORAL360 mgExact identifier — unii candidate
15 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDDOUCHE / VAGINALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 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 STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii candidate
28 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 STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JCAPSULE / ORAL401 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FOR SUSPENSION / ORAL131 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET, COATED / ORAL333.3 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JTABLET / SUBLINGUAL28 mgExact identifier — unii candidate
15 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii candidate
37 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, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTROCHE / ORAL300 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 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
94861f03-69a1-4450-8cc3-b2b1ad2f06e716f88417-d6cc-47fd-af6c-e916626c1bc32018-01-30WarningsExact identifier
spl id: 94861f03-69a1-4450-8cc3-b2b1ad2f06e7
spl set id: 16f88417-d6cc-47fd-af6c-e916626c1bc3

Reported adverse events (FAERS/openFDA)#

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