FDA.reportPublic FDA data

Vicks ZzzQuil Ultra

Manufacturer
Select Consumer Group
Effective date
2026-10-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-21 00:01:05

Label at a glance#

ProductVicks ZzzQuil Ultra
Active ingredientDOXYLAMINE SUCCINATE
Label structure12 sections

Dosage and administration

adults & 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 68-77° F (20°-25° C) retain carton until time of use see carton end panel for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (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

OTC - DO NOT USE SECTION

Do not use in children under 12 years of age

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any other drugs

OTC - WHEN USING SECTION

When using this product

  • avoid alcoholic beverages
  • take only at bedtime

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

(1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

adults & 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 68-77° F (20°-25° C)
  • retain carton until time of use
  • see carton end panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate,
microcrystalline cellulose, sodium starch glycolate

Questions?

OTC - QUESTIONS SECTION

1-877-881-5813

SPL UNCLASSIFIED SECTION

Tamper Evident:Do not use if blister is opened or torn. If difficult to open, use scissors.

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

ZzzQuil™
ULTRA
NIGHTTIME SLEEP-AID
Doxylamine succinate tablets, 25 mg nighttime sleep-aid

24 TABLETS

From the makers of NyQuil

Clinically tested, proven effective

actual size

1 TABLET

PER DOSE

zzqui1zzqui1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130655708119327GTIN-13: 0655708119327
EAN-13: 0655708119327
GTIN-12: 655708119327
UPC-A: 655708119327
GTIN storage (14 digits): 00655708119327		2611932022 - ZzzQuil Nighttime Sleep Aid - 1932-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85237-193285237-1932-0, 85237-1932-1
69423-902

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040167-001DOXYLAMINE SUCCINATEDOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18c2088c7a36db…
2026-09-14 22:38:342026-08A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1884e616aacf4f…
2026-08-18 06:07:402026-07A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-183f01610625f2…
2019-09-15 20:21 UTC2019-09A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-183a93d1ddd44b…

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 3 · 46 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
ultra sleep aidDOXYLAMINE SUCCINATEWalgreen Company90a5986d-2555-4c2d-8e41-16537ff1aa362026-08-19WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDOXYLAMINE SUCCINATEH E B17667c28-b61e-4974-8736-5de59f69b3b02026-07-09WarningsName fallback
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 AidDOXYLAMINE SUCCINATEAmerisource Bergenea842bc4-9788-49a9-a7e1-d6e3dd61056a2026-06-15WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED6d6e47df-a965-4813-8414-9841ed2f9e0c2026-06-15WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
sleep aidDOXYLAMINE SUCCINATERite Aid Corporation4b5fdb06-f205-4424-b4cb-dddef921485b2026-05-27WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
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
sleep aidDOXYLAMINE SUCCINATEWalgreen Company489ee606-15f4-4032-a62b-35c8844f1a262026-05-08WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
nighttime sleep aidDOXYLAMINE SUCCINATEHyVee Inc95b12a14-21ee-431d-a892-46f8cdca2d7a2026-04-15WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI005b5ad8-d762-46b5-a7a5-e0ff11ba936a2026-04-06WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDOXYLAMINE SUCCINATEBetter Living Brands, LLC92827089-88d5-4f4e-bcbe-3ca6d94ee96c2026-03-27WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATEMeijer Distribution Inc96a7c284-4666-4dac-b71e-9433f62580ad2026-03-27WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDOXYLAMINE SUCCINATEL.N.K. International, Inc.918ad808-ccfd-429f-9052-19905a6346062026-03-27WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Unisom SleepTabsDOXYLAMINE SUCCINATEChattem, Inc.7ae32d74-76a0-47e2-9e5c-812426413c4e2026-03-25WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATEMeijer Distribution Incde0a6f68-6988-44df-9fab-b87620fd32e82026-03-24WarningsName fallback
generic name: DOXYLAMINE SUCCINATE

Reported adverse events (FAERS/openFDA)#

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