TopCare Sleep Aid Doxylamine succinate 25 mg Tablet, 32-count — NDC 36800-441-64 (Billing 36800-0441-64)
by Topco Associates LLC · 32 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
This is a package of 32 tablets of TopCare Sleep Aid Doxylamine succinate 25 mg Tablet from Topco Associates LLC, marketed since Jan 1997 and currently FDA-listed. It is this product's only package size.
NDC 36800-0441-64
🏷️ FDA NDC (as labeled)
36800-441-64
billing pads the product segment with a zero
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
36800-441-64
Product NDC
36800-441
11-digit billing NDC
36800044164
NCPDP billing unit
EA — each (per item)
RxCUI
1101446
UNII
V9BI9B5YI2
Application #
ANDA040167
SPL Set ID
15dc89c4-b7ce-4d36-8107-f501daaf289b
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
1997-01-29
Route
ORAL
Dosage form
TABLET
Substance
DOXYLAMINE SUCCINATE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
60300010100310
GPI class
Sleep Aid
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
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 36800-441-64 — a 5-3-2 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 product segment → 36800-0441-64. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name SLEEP AID 25 MG TABLET 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Doxylamine Succinate — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Doxylamine succinate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| 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. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 36800-0441-64 You're viewing this Main listing | 32 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK | 1997-01-29 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 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 mgthis 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
1997
On the market since
Jan 1997
📍
2026
Currently FDA-listed
29 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.
- FDA Orange Book · refreshed Sep 3, 2026
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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerTopco Associates LLC
Application holderL PERRIGO CO
FDA applicationANDA040167 (ANDA)
Labeler code36800
First marketedJan 1997
Product typeHuman Otc Drug
Portfolio408 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 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
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Use • helps to reduce difficulty in falling asleep
⏱️ Dosage and Administration ▾
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 ▾
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).
📦 Storage and Handling ▾
Other information • store at 20°-25°C (68°-77°F) • keep carton. It contains important information.
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Doxylamine succinate 25 mg
🧪 Inactive Ingredients ▾
Inactive ingredients anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
🎯 Purpose ▾
Purpose Nighttime sleep-aid
📄 Do Not Use ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
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).
📄 Questions or Comments ▾
Questions or comments? 1-888-423-0139
📄 Package Label / Principal Display Panel ▾
Principal Display Panel TopCare ® health COMPARE TO UNISOM ® SLEEPTABS ® ACTIVE INGREDIENT NIGHTTIME Sleep Aid DOXYLAMINE SUCCINATE TABLETS, 25 mg NIGHTTIME SLEEP-AID • Clinically Tested, Proven Effective • One Tablet Per Dose 32 TABLETS actual size topcare-sleep-aid-carton-image.jpg
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Topco Associates LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topco Associates LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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.