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good sense sleep aid ultra doxylamine succinate 25 mg Tablet, Coated, 48-count — NDC 00113-4032-67 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

good sense sleep aid ultra doxylamine succinate 25 mg Tablet, Coated, 48-count — NDC 0113-4032-67 (Billing 00113-4032-67)

by L. Perrigo Company · 1 BOTTLE in 1 CARTON / 48 TABLET, COATED in 1 BOTTLE

This is a package of 48 tablets of good sense sleep aid ultra doxylamine succinate 25 mg Tablet, Coated from L. Perrigo Company, marketed since Feb 2025 and currently FDA-listed; retail pharmacies pay about $0.1158 per tablet (NADAC).

NDC 00113-4032-67
🏷️ FDA NDC (as labeled) 0113-4032-67 billing pads the labeler segment with a zero
This package
Contains48-count Cost per ea$0.1158 NADAC Per package$5.56 / 48 tablets Pack sizes2 compare ↓
Product page 00113-4032-62 Also comes in: 24 tablets 0113-4032-62
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0113-4032-67 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0113 labeler · 4032 product · 67 package
Package marketed since
Feb 27, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
48 EA per package
Barcode (UPC-A, from the NDC)
3 0113403267 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0113-4032-67
Product NDC 0113-4032
11-digit billing NDC 00113403267
NCPDP billing unit EA — each (per item)
RxCUI 1101446
UNII V9BI9B5YI2
Application # ANDA040167
SPL Set ID 300826cf-6d0d-4efb-97aa-aa7dfff3add2
Established class (EPC) Antihistamine
Mechanism of action Histamine Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-27
Route ORAL
Dosage form TABLET, COATED
Substance DOXYLAMINE SUCCINATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 60300010100310
GCN Seq No 003707
GCN 11730
HICL code 004482
Ingredient (HICL) Doxylamine Succinate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2E
Therapeutic class — specific (HIC3) Sedative-Hypnotics,Non-Barbiturate
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name GS SLEEP AID ULTRA 25 MG TAB
FDB brand name Sleep Aid Ultra
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 003707
  • GCN: 11730
  • GPI-14 (Medi-Span): 60300010100310
  • HICL (First Databank): 004482
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 1101446
Why two NDCs? The FDA registers this code as 0113-4032-67 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00113-4032-67. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Antihistamine class.

Pharmacologic class Antihistamine
Drug family (ATC) Aminoalkyl ethers
How it works Histamine Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name GS SLEEP AID ULTRA 25 MG TAB Ingredient Doxylamine Succinate
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Sleep-aid tablets help you fall asleep more easily. Some NyQuil and other liquid or syrup products relieve hay fever and upper respiratory allergy sympto...
  • Adults and children 12 and over take one tablet about 30 minutes before bed, once daily or as your doctor directs. Take it only at bedtime. These tablets are not for children under...
  • No. The label says to avoid alcohol while using doxylamine. Also don’t drive or run machinery.
  • Yes, if you have emphysema or chronic bronchitis, glaucoma, or trouble urinating from an enlarged prostate. Also check if you take sedatives, other sleep aids, or other antihistami...
📖 Read our full Doxylamine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.116 $5.56 / 48 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.125 $0.116
▼ Down 7% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00113-4032-62 0113-4032-62 Main listing 1 BOTTLE in 1 CARTON / 24 TABLET, COATED in 1 BOTTLE $0.1158 / ea $2.78 2025-02-27 — Active
00113-4032-67 You're viewing this 1 BOTTLE in 1 CARTON / 48 TABLET, COATED in 1 BOTTLE $0.1158 / ea $5.56 2025-02-27 — Active

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.1158 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 48-count package — 1 bottle in 1 carton / 48 tablet, coated in 1 bottle.
How does this package differ from NDC 00113-4032-62?
Both are good sense sleep aid ultra doxylamine succinate 25 mg Tablet, Coated — the drug itself is identical. This page's package is the 48-count one, while NDC 00113-4032-62 is the 24 tablets package.
What NDC number is used to bill for this package of good sense sleep aid ultra doxylamine succinate 25 mg Tablet, Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good sense sleep aid 25 mg 00113-0441-64 L. 32 tablets $0.116 — Availability likely —
good sense sleep aid ultra 25 mgthis 00113-4032-67 L. 48 tablets $0.116 — Availability likely —
Nighttime Sleep Aid 25 mg 46122-0788-15 Amerisource 32 tablets $0.116 — Availability likely —
Sleep-Aid 25 mg 70000-0567-01 Cardinal 48 tablets $0.116 — Availability likely —
Sleep Aid 25 mg 70677-1129-01 Strategic 32 tablets $0.116 — Availability likely —
good sense sleep aid ultra 25 mg 00113-6044-67 L. 48 tablets — — FDA listed —
Sleep Aid 25 mg 00363-0386-12 Walgreen 100 tablets — — FDA listed —
sleep aid 25 mg 00363-3462-80 Walgreen 96 tablets — — FDA listed —
ultra sleep aid 25 mg 00363-8011-62 Walgreen 24 tablets — — FDA listed —
up and up nighttime sleep aid 25 mg 11673-0171-01 Target 96 tablets — — FDA listed —
sleep aid 25 mg 11822-0441-00 Rite 48 tablets — — FDA listed —
sleep aid 25 mg 11822-3000-00 Rite 24 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 21130-0986-27 Better 32 tablets — — FDA listed —
Nighttime Sleep-Aid 25 mg 30142-0366-27 Kroger 32 tablets — — FDA listed —
Sleep Aid 25 mg 30142-0386-27 Kroger 32 tablets — — FDA listed —
TopCare Sleep Aid 25 mg 36800-0441-64 Topco 32 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 37808-0886-27 H 32 tablets — — FDA listed —
Sleep Aid 25 mg 41163-0986-22 United 48 tablets — — FDA listed —
Unisom SleepTabs 25 mg 41167-0063-05 Chattem, 16 tablets — — FDA listed —
Unisom SleepTabs 25 mg 41167-0608-00 Chattem, 16 tablets — — FDA listed —
Sleep Aid 25 mg 41250-0441-01 Meijer 96 tablets — — FDA listed —
Sleep Aid 25 mg 41250-0986-22 Meijer 48 tablets — — FDA listed —
CareOne Nighttime Sleep Aid 25 mg 41520-0634-64 American 32 tablets — — FDA listed —
nighttime sleep aid 25 mg 42507-0033-64 HyVee 32 tablets — — FDA listed —
Sleep Aid 25 mg 49035-0968-27 Wal-Mart 32 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 50844-0260-21 L.N.K. 16 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 50844-0386-19 L.N.K. 8 tablets — — FDA listed —
Sleep Aid 25 mg 51316-0368-22 CVS 48 tablets — — FDA listed —
Sleep Aid 25 mg 55301-0986-27 ARMY 32 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 55319-0439-16 Family 16 tablets — — FDA listed —
dg health sleep aid 25 mg 55910-0909-53 Dolgencorp 12 tablets — — FDA listed —
sleep aid 25 mg 56062-0441-01 Publix 96 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 59779-0441-01 CVS 96 tablets — — FDA listed —
Sleep Aid 25 mg 63981-0986-96 COSTCO 96 tablets — — FDA listed —
Nighttime Sleep Aid, 24-7 Life by 7-Eleven 25 mg 66715-5642-04 Lil' 16 tablets — — FDA listed —
ZzzQuil ULTRA, Travel BASIX 25 mg 66715-6451-03 Lil' 3 tablets — — FDA listed —
ZzzQuil ULTRA, Lil Drug Store 25 mg 66715-9751-02 Lil' 2 tablets — — FDA listed —
berkley and jensen sleep aid 25 mg 68391-0441-02 BJWC 192 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 69168-0439-06 Allegiant 120 tablets — — FDA listed —
Vicks ZzzQuil Ultra 25 mg 69423-0902-12 The 12 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 69842-0386-22 CVS 48 tablets — — FDA listed —
Basic Care Sleep Aid 25 mg 72288-0441-01 Amazon.com 96 tablets — — FDA listed —
SLEEP AID 25mg 25 mg 73581-0205-02 YYBA 200 tablets — — FDA listed —
Topcare Sleep Aid 25 mg 76162-0159-62 Topco 24 tablets — — FDA listed —
topcare sleep aid 25 mg 76162-0603-67 Topco 48 tablets — — FDA listed —
sleep aid ultra 25 mg 79481-0096-00 Meijer, 24 tablets — — FDA listed —
Night Time Sleep Aid 25 mg 80513-0371-25 Advanced 225 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 85828-0439-38 Grocery 32 tablets — — FDA listed —
Nocto Sleep Aid 25 mg 27854-0375-01 Belmora 24 tablets — — FDA listed —
Sleep Aid 25 mg 72288-0432-01 Amazon.com 96 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Purple
ShapeOval
Imprint15N
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Doxylamine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5C5403N26O
    Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
  • UNII L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII 4AQJ3LG584
    A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

14 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesanhydrous dibasic calcium phosphate, arabic gum, artificial flavor, carmine, dibasic calcium phosphate dihydrate, FD&C blue no. 2 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, modified food starch, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, sucralose, talc, titanium dioxide, triacetin

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerL. Perrigo Company
Application holderL PERRIGO CO
FDA applicationANDA040167 (ANDA)
Labeler code00113
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio228 products on file

More NDCs from L. Perrigo Company labeler code 00113

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 9 words ▾

Use • helps to reduce difficulty in falling asleep

⏱️ Dosage and Administration 39 words ▾

Directions • 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

⚠️ Warnings 167 words ▾

Warnings Do not use • 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 • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking • a sedative or any other sleep-aid • tranquilizers • any other antihistamines • any other drugs When using this product • avoid alcoholic beverages • do not drive a motor vehicle or operate machinery • take only at bedtime 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. If pregnant or breast-feeding, ask a health professional before use. 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).

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Doxylamine succinate 25 mg

🧪 Inactive Ingredients 41 words ▾

Inactive ingredients anhydrous dibasic calcium phosphate, arabic gum, artificial flavor, carmine, dibasic calcium phosphate dihydrate, FD&C blue no. 2 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, modified food starch, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, sucralose, talc, titanium dioxide, triacetin

🎯 Purpose 3 words ▾

Purpose Nighttime sleep-aid

📄 Do Not Use 28 words ▾

Do not use • 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 29 words ▾

Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland

📄 Ask a Doctor or Pharmacist Before Use If 28 words ▾

Ask a doctor or pharmacist before use if you are taking • a sedative or any other sleep-aid • tranquilizers • any other antihistamines • any other drugs

📄 When Using This Product 23 words ▾

When using this product • avoid alcoholic beverages • do not drive a motor vehicle or operate machinery • take only at bedtime

📄 Stop Use and Ask a Doctor If 26 words ▾

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.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 22 words ▾

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).

📄 Other Information 14 words ▾

Other information • store at 20-25°C (68-77°F) • keep carton. It contains important information.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-719-9260

📄 Package Label / Principal Display Panel 43 words ▾

Package/Label Principal Display Panel GOODSENSE ® Nighttime Sleep Aid Ultra Doxylamine Succinate Tablets 25 mg Actual Size Nighttime Sleep-Aid 1 Tablet Per Dose Berry Flavor Clinically Tested, Proven Effective 24 Tablets Compare to active ingredient of Vicks ® ZzzQuil ® Ultra Tablets goodsense-sleep-aid-berry-carton-image.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Doxylamine succinate — the ingredient across all brands.

Top reported reactions

Somnolence569
Fatigue421
Nausea363
Dizziness292
Insomnia281
Headache279
Diarrhoea262

Age at onset

Neonate23
Infant3
Child17
Adolescent20
Adult1,799
Elderly303

Reporter sex

7,688 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization1,339
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 808 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 00113-4031-00 · L. 00113-4053-00 · L. →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.