FDA.reportPublic FDA data

Vicks ZzzQuil Ultra

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-07
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
daily-update
Hydrated at
2026-10-13 04:05:14

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 - 24 Tablet Carton

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

902902

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130323900042728GTIN-13: 0323900042728
EAN-13: 0323900042728
GTIN-12: 323900042728
UPC-A: 323900042728
GTIN storage (14 digits): 00323900042728		902.jpg
Data codeCode 12844162KTC5902.jpg
Data codeData Matrix21660433902.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-902-012024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra
69423-902-012024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra
69423-902-122024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra
69423-902-122024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra
69423-902-242024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra
69423-902-242024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra
69423-902-322024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra
69423-902-322024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra
69423-902-482024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra
69423-902-482024-01-30C16284748780-11030e365-088a-111a-e063-dadaa90a10e2Vicks ZzzQuil Ultra

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
69423-90269423-902-12, 69423-902-24, 69423-902-48, 69423-902-01, 69423-902-32

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
142025-10-02full-release2026-06-01 01:15:38

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
402e64c4-5771-d190-e063-6294a90a7fe2c29f6f9a-7b55-30c3-e053-2995a90a9de72025-10-02WarningsExact identifier
spl set id: c29f6f9a-7b55-30c3-e053-2995a90a9de7

Reported adverse events (FAERS/openFDA)#

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