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Sleep-Aid Doxylamine succinate 25 mg Tablet, 48-count — NDC 70000-0567-01 package photo

Sleep-Aid Doxylamine succinate 25 mg Tablet, 48-count

by Cardinal Health 110, LLC. DBA Leader · 3 BLISTER PACK in 1 CARTON (70000-0567-1) / 16 TABLET in 1 BLISTER PACK
NDC 70000-0567-01
🏷️ FDA NDC (as labeled) 70000-0567-1 billing pads the package segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 70000-0567-1
Product NDC 70000-0567
11-digit billing NDC 70000056701
NCPDP billing unit EA — each (per item)
RxCUI 1101446
UNII V9BI9B5YI2
UPC 0096295139891
Application # ANDA040564
SPL Set ID 96e8d6df-e717-4ffc-9502-498024c9665f
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 2020-07-23
Route ORAL
Dosage form TABLET
Substance DOXYLAMINE SUCCINATE
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 SLEEP AID 25 MG TABLET
FDB brand name Sleep Aid
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0567-1 — a 5-4-1 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 package segment → 70000-0567-01. 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.

🏭 Manufacturer & labeler

LabelerCardinal Health 110, LLC. DBA Leader
Application holderLNK INTERNATIONAL INC
FDA applicationANDA040564 (ANDA)
Labeler code70000
First marketedJul 2020
Product typeHuman Otc Drug
Portfolio163 products on file
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.

🩺 Clinical

Label name SLEEP AID 25 MG TABLET Ingredient Doxylamine Succinate
📖 What it is MedlinePlus · NLM

Doxylamine is used to treat insomnia (difficulty falling asleep or staying asleep).   Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Doxylamine is also used in combination with acetaminophen, dextromethorphan, decongestants and other medications to manage cold and flu symptoms. This monograph only includes information about the use of doxylamine alone. If you are taking the doxylamine combination products, read the information on the package label or ask your doctor or pharmacis...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product you have. If you picked up a sleep-aid tablet — like Nighttime Sleep Aid or berkley and jensen sleep aid — it's meant to help you fall asleep more easily....
  • For sleep-aid tablets, the directions say to take one tablet about 30 minutes before you plan to go to bed, and only once per night. It's important that you have a full night's sle...
  • How do I take the sleep-aid tablet — can I take it earlier in the evening?
  • No — please avoid alcohol entirely while you're using doxylamine. Alcohol and doxylamine both cause drowsiness, and combining them can make the sedation much stronger than you expe...
📖 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.

💊 What it looks like

Color blue
ShapeOval
Imprint44;386
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.

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

  • 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 J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy 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 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

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

The official label also statesdibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

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.

💲 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 $0.3201 $15.36 / 48 tablets
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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.125 $0.110
▼ Down 5% over the last 24 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.

🔁 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 mg 00113-4032-62 L. 24 tablets $0.116 — Availability likely —
Nighttime Sleep Aid 25 mg 46122-0788-15 Amerisource 32 tablets $0.116 — Availability likely —
Sleep-Aid 25 mgthis 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

🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 years 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70000-0567-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
4.9K
Units reimbursed last 4 qtrs
149.7K
Gross reimbursed last 4 qtrs
$47.9K
Avg / prescription
$9.87
Avg / unit
$0.3201
Latest quarter Q4 2025
1.2KRx
Medicaid pays / ea
$0.3201
gross reimbursed
vs
NADAC / ea
$0.1158
acquisition cost
=
Spread
+$0.2043
+176% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
89% MCO
Fee-for-service · 530 Rx Managed care · 4,326 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 333 units · 29.4 per 100k residents MT North Dakota: no data reported ND Minnesota: 8,966 units · 156 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: 1,709 units · 264 per 100k residents VT New Hampshire: no data reported NH Oregon: 7,625 units · 180 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,092 units · 8.7 per 100k residents IL Indiana: no data reported IN Ohio: 29,535 units · 251 per 100k residents OH Pennsylvania: 22,534 units · 174 per 100k residents PA New Jersey: 9,764 units · 105 per 100k residents NJ Massachusetts: 22,138 units · 316 per 100k residents MA California: 550 units · 1.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 4,953 units · 250 per 100k residents NE Missouri: 3,018 units · 48.7 per 100k residents MO Kentucky: 21,800 units · 482 per 100k residents KY West Virginia: no data reported WV Virginia: 2,053 units · 23.6 per 100k residents VA Maryland: 5,706 units · 92.3 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 1,225 units · 16.5 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 617 units · 11.5 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 333 units · 3.0 per 100k residents GA D.C.: 3,984 units · 587 per 100k residents DC Hawaii: no data reported HI Texas: 1,786 units · 5.9 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.4587
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 D.C. 587 /100k
2 Kentucky 482 /100k
3 Massachusetts 316 /100k
4 Vermont 264 /100k
5 Ohio 251 /100k
6 Nebraska 250 /100k
7 Oregon 180 /100k
8 Pennsylvania 174 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 Sleep-Aid (this brand).

Top reported reactions

Completed Suicide818
Death581
Fatigue551
Toxicity To Various Agents540
Nausea505
Infusion Related Reaction452
Dyspnoea432

Age at onset

Neonate16
Infant3
Child16
Adolescent19
Adult1,103
Elderly113

Reporter sex

10,464 reports
Male · 41%
Female · 58%
Unknown · 1%

Serious outcomes

Hospitalization3,093
Death3,080
Life-threatening539
Disabling174
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 601 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70000-0567-01 You're viewing this 3 BLISTER PACK in 1 CARTON (70000-0567-1) / 16 TABLET in 1 BLISTER PACK 2020-07-23 Active

📄 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 8 words ▾

Use helps to reduce difficulty in falling asleep

⏱️ Dosage and Administration 37 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 151 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 sedatives 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.

📦 Storage and Handling 34 words ▾

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

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Doxylamine succinate 25 mg

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

🎯 Purpose 3 words ▾

Purpose Nighttime sleep-aid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0565-01 · Cardinal 70000-0568-01 · Cardinal →
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.