Home › NDC Lookup › Ingredients › Ibuprofen, Diphenhydramine Hcl › 36800-0756-40
Ibuprofen PM IBUPROFEN, DIPHENHYDRAMINE HCL 200 mg; 25 mg Capsule, Liquid Filled, 40-count — NDC 36800-0756-40 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ibuprofen PM IBUPROFEN, DIPHENHYDRAMINE HCL 200 mg; 25 mg Capsule, Liquid Filled, 40-count — NDC 36800-756-40 (Billing 36800-0756-40)

by TOP CARE (Topco Associates LLC) · 1 BOTTLE, PLASTIC in 1 BOX / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

This is a package of 40 capsules of Ibuprofen PM IBUPROFEN, DIPHENHYDRAMINE HCL 200 mg; 25 mg Capsule, Liquid Filled from TOP CARE (Topco Associates LLC), marketed since Jul 2018 and currently FDA-listed, this package's marketing is listed to end Dec 2026. It is this product's only package size.

NDC 36800-0756-40
🏷️ FDA NDC (as labeled) 36800-756-40 billing pads the product segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 36800-756-40
Product NDC 36800-756
11-digit billing NDC 36800075640
RxCUI 901814
UNII WK2XYI10QM, TC2D6JAD40
UPC 0036800207691
Application # ANDA200888
SPL Set ID 7af82ca5-ea36-4b72-88b8-0fe68348d269
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-31
Marketing end 2026-12-31
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 901814
Why two NDCs? The FDA registers this code as 36800-756-40 — 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 → 36800-0756-40. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 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

📖 What it is MedlinePlus · NLM

Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine 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. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • No — this product is specifically for nights when you have both minor pain AND trouble sleeping at the same time. It's not meant to be used as a plain sleep aid. If you're struggli...
  • What exactly is this medicine for — can I just take it to help me sleep?
  • Take 2 capsules or caplets at bedtime — whichever form your product comes in. Don't take more than that in 24 hours. If it bothers your stomach, go ahead and take it with food or a...
  • How do I take it, and is it okay to take with food?
📖 Read our full Diphenhydramine / Ibuprofen guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 mLPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
36800-0756-40 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 BOX / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2018-07-31 Dec 31, 2026 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ibuprofen PM 200 mg/1; 25 mg 00363-0207-11 WALGREEN 20 capsules — — FDA listed —
Advil Pm 25 mg/1; 200 mg 00573-0148-06 Haleon 40 capsules — — FDA listed —
Advil Pm 25 mg/1; 200 mg 00573-0167-25 Haleon 20 capsules — — FDA listed —
Ibuprofen, Diphenhydramine Hcl 200 mg/1; 25 mg 11673-0225-15 TARGET 40 capsules — — FDA listed —
Ibuprofen, Diphenhydramine Hcl 200 mg/1; 25 mg 11822-0789-04 Rite 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 30142-0232-15 KROGER 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 36800-0237-15 TOP 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mgthis 36800-0756-40 TOP 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 41250-0285-15 MEIJER 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 42681-0061-01 Whole 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 49035-0670-15 Wal-Mart 40 capsules — — FDA listed —
Diphenhydramine HCl and Ibuprofen 25 mg/1; 200 mg 58602-0717-30 Aurohealth 160 capsules — — FDA listed —
Diphenhydramine HCl and Ibuprofen 25 mg/1; 200 mg 58602-0814-10 Aurohealth 32 capsules — — FDA listed —
Diphenhydramine HCl and Ibuprofen 25 mg/1; 200 mg 58602-0887-10 Aurohealth 32 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 59640-0020-15 HEB 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 63868-0829-40 CHAIN 40 capsules — — FDA listed —
Ibuprofen and Diphenhydramine HCl 200 mg/1; 25 mg 63941-0682-15 VALU 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 68016-0057-40 Premier 40 capsules — — FDA listed —
Ibuprofen, Diphenhydramine Hcl 200 mg/1; 25 mg 69452-0205-04 Bionpharma 6 capsules — — FDA listed —
pain relief pm 200 mg/1; 25 mg 69452-0264-22 Bionpharma 120 capsules — — FDA listed —
pain relief pm 200 mg/1; 25 mg 69452-0507-78 Bionpharma 80 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 69842-0870-15 CVS 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 69842-0913-40 CVS 40 capsules — — Discontinued —
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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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.

What it looks like

Color blue
ShapeOval
Imprint1007
Size16 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 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII NL4J9F21N9
    Polyethylene glycol 600 is a synthetic liquid polymer used as a solvent and humectant in medicines. It helps dissolve active ingredients and keeps products from drying out.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6O92ICV9RU
    A waxy substance derived from sorbitol that helps mix oil and water together in medicines. It's used as an emulsifier to keep ingredients evenly blended and stable.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesD&C red #33, FD&C blue #1, gelatin, medium chain triglycerides, polyethylene glycol 600, potassium hydroxide, purified water, sorbitan, sorbitol

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

LabelerTOP CARE (Topco Associates LLC)
Application holderONESOURCE SOFTGELS PTE LTD
FDA applicationANDA200888 (ANDA)
Labeler code36800
First marketedJul 2018
Product typeHuman Otc Drug
Portfolio35 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 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 20 words ▾

Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep

⏱️ Dosage and Administration 29 words ▾

Directions do not take more than directed adults and childlren 12 years and over: take 2 capsules at bedtime do not take more than 2 capsules in 24 hours

⚠️ Warnings ~2 min read ▾

Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you: have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug are age 60 or older take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] take more or for a longer time than directed have 3 or more alcoholic drinks every day while using this product Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use in children under 12 years of age if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery unless you have time for a full night’s sleep with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have glaucoma you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers you have a breathing problem such as emphysema or chronic bronchitis you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, or any other sleep-aid taking any other drug taking any other antihistamines taking aspirin for heart attack or stroke, because ibuprofen may decease this benefit of aspirin under a doctor's care for any continuing medical illness When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing leg swelling slurred speech weakness in one part or side of body pain gets worse or last more than 10 days sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of a serious underlying medical illness redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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 42 words ▾

Other information each capsule contains: potassium 20 mg store at 20º to 25ºC (68º to 77ºF) avoid excessive heat above 40°C (104°F) protect from light swallow whole: do not crush, chew, or dissolve read all warnings and directions before use. Keep carton.

🧪 Active Ingredient 28 words ▾

Active ingredient (in each capsule) Diphenhydramine hydrochloride 25 mg Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *non-steroidal anti-inflammatory drug

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients D&C red #33, FD&C blue #1, gelatin, medium chain triglycerides, polyethylene glycol 600, potassium hydroxide, purified water, sorbitan, sorbitol

🎯 Purpose 5 words ▾

Purpose Nighttime sleep-aid Pain Reliever

📄 Do Not Use 56 words ▾

Do not use in children under 12 years of age if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery unless you have time for a full night’s sleep with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain

📄 Ask a Doctor Before Use If 82 words ▾

Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have glaucoma you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers you have a breathing problem such as emphysema or chronic bronchitis you have trouble urinating due to an enlarged prostate gland

📄 Ask a Doctor or Pharmacist Before Use If 50 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, or any other sleep-aid taking any other drug taking any other antihistamines taking aspirin for heart attack or stroke, because ibuprofen may decease this benefit of aspirin under a doctor's care for any continuing medical illness

📄 When Using This Product 28 words ▾

When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs

📄 Stop Use and Ask a Doctor If 99 words ▾

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing leg swelling slurred speech weakness in one part or side of body pain gets worse or last more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness redness or swelling is present in the painful area any new symptoms appear

🤰 If Pregnant or Breast-Feeding 47 words ▾

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

📄 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).

📄 Questions or Comments 7 words ▾

Questions or comments? Call toll free 1-888-423-0139

📄 Package Label / Principal Display Panel 113 words ▾

Principal Display Panel COMPARE TO ADVIL®PM LIQUI-GELS® ACTIVE INGREDIENTS† NIGHTTIME Ibuprofen PM Capsules PAIN RELIEVER (NSAID) • NIGHTTIME SLEEP-AID IBUPROFEN & DIPHENHYDRAMINE HCI 200 mg/25mg SOFTGELS ** **Liquid-Filled Capsules †This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® PM Liqui-Gels®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO PLVA0318 [email protected] www.topcarebrand.com

Product Packaging TOPCARE Ibuprofen 200 mg Softgels Diphenhydramine HCI 25 mg, Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

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 ✓ Available
Inactive ingredients (structured) ✓ 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 it is currently marketed — but TOP CARE (Topco Associates LLC) has reported a marketing end date of 2026-12-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
TOP CARE (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.
← 36800-0755-39 · Topco 36800-0766-16 · Topco →
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.