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Topcare Ultra Strength Stomach Relief Bismuth subsalicylate 525 mg/15mL Liquid, 236 mL — NDC 76162-0022-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Topcare Ultra Strength Stomach Relief Bismuth subsalicylate 525 mg/15mL Liquid, 236 mL — NDC 76162-022-04 (Billing 76162-0022-04)

by Topco Associates, LLC · 236 mL in 1 BOTTLE

This is a package of 236 mL of Topcare Ultra Strength Stomach Relief Bismuth subsalicylate 525 mg/15mL Liquid from Topco Associates, LLC, marketed since Jan 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 76162-0022-04
🏷️ FDA NDC (as labeled) 76162-022-04 billing pads the product segment with a zero
This package
Contains236 mL Pack sizes2 compare ↓
Main listing for product 76162-022 · Also comes in: 354 ml 76162-022-05
OTC 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76162-022-04
Product NDC 76162-022
11-digit billing NDC 76162002204
RxCUI 308763
UNII 62TEY51RR1
UPC 0036800993297, 0036800135857
Application # M008
SPL Set ID 908da10c-2ed1-4917-a98b-bab63d7990d4
Established class (EPC) Bismuth
Chemical class Bismuth
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-05
Route ORAL
Dosage form LIQUID
Substance BISMUTH SUBSALICYLATE
Quick answers
  • RxCUI (RxNorm): 308763
Why two NDCs? The FDA registers this code as 76162-022-04 — 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 → 76162-0022-04. 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 Bismuth class.

Pharmacologic class Bismuth
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

📗 Our plain-language guide HelloPharmacist
  • It relieves diarrhea, including traveler's diarrhea. It also helps with upset stomach after overindulging in food and drink, such as heartburn, indigestion, nausea, gas, belching a...
  • Use it only until the diarrhea stops, and no more than 2 days. If you're not better by then, or you get worse sooner, stop and see a doctor. Drink plenty of clear fluids while you...
  • That's a known, temporary and harmless effect of this medicine. But black stool can also signal bleeding, so do not use it if you already have bloody or black stool.
  • Children under 12 should be checked by a doctor first. Children and teens who have or are recovering from chicken pox or flu-like symptoms should not use it because of Reye's syndr...
📖 Read our full Bismuth Subsalicylate 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 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.
Try another pack size: 354 ml
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
76162-0022-04 You're viewing this Main listing 236 mL in 1 BOTTLE 2022-01-05 — Active
76162-0022-05 76162-022-05 354 mL in 1 BOTTLE 2022-01-05 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 236 mL — 236 ml in 1 bottle.
How does this package differ from NDC 76162-0022-05?
Both are Topcare Ultra Strength Stomach Relief Bismuth subsalicylate 525 mg/15mL Liquid — the drug itself is identical. This page's package is the 236 mL one, while NDC 76162-0022-05 is the 354 ml package.
What NDC number is used to bill for this package of Topcare Ultra Strength Stomach Relief Bismuth subsalicylate 525 mg/15mL Liquid?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Stomach Relief Ultra 525 mg/15mL 70000-0045-01 Cardinal 355 ml $0.010 — Availability likely —
Ultra Stomach Relief 525 mg/15mL 62011-0436-01 Strategic 237 ml $0.010 — Discontinued —
Stomach Relief Ultra 525 mg/15mL 00536-1287-36 Rugby 237 ml $0.011 — Availability likely —
Good Neighbor Ultra Strength Stomach Relief 525 mg/15mL 46122-0747-06 AMERISOURCE 236 ml $0.012 — Availability likely —
Quality Choice Stomach Relief 528 525 mg/15mL 83324-0021-08 Chain 236 ml $0.012 — Availability likely —
Walgreen Ultra Strength Pink Bismuth 525 mg/15mL 00363-7070-04 WALGREENS 118 ml — — FDA listed —
Walgreen Stomach Relief Ultra Strength 525 mg/15mL 00363-7071-12 WALGREENS 354 ml — — FDA listed —
Soothe Ultra Strength 525 mg/15mL 00363-7370-04 Walgreens 118 ml — — FDA listed —
Ultra Strenght Pink Bismuth 525 mg/15mL 11673-0907-08 TARGET 236 ml — — FDA listed —
RITE AID Ultra Strnght Pink Bismuth 525 mg/15mL 11822-7070-02 RITE 354 ml — — FDA listed —
SIGNATURE CARE Ultra Strength Stomach 525 mg/15mL 21130-0193-12 SAFEWAY 354 ml — — FDA listed —
Ultra Stomach Relief 525 mg/15mL 21130-0662-08 Safeway, 237 ml — — FDA listed —
TopCare Stomach Relief Ultra Strength 525 mg/15mL 36800-0341-08 TOPCO 236 ml — — FDA listed —
Pepto-Bismol Ultra 525 mg/15mL 37000-0440-04 The 118 ml — — FDA listed —
Pepto-Bismol Ultra Cherry 525 mg/15mL 37000-0441-04 The 118 ml — — FDA listed —
HEB Stomach Relief Max Strength 1050 mg/30mL 37808-0770-08 HEB 236 ml — — FDA listed —
Equaline Maximum Strength Stomach Relief 1050 mg/30mL 41163-0937-04 UNITED 237 ml — — FDA listed —
Meijer Stomach Relief Regular Strength 525 mg/15mL 41250-0211-12 MEIJER 354 ml — — FDA listed —
PUBLIX Stomach Relief Ultra Strength 525 mg/15mL 41415-0707-12 PUBLIX 354 ml — — FDA listed —
Stomach Relief Ultra 525 mg/15mL 49035-0293-12 EQUATE 355 ml — — FDA listed —
Stomach Relief Ultra Strength 525 mg/15mL 49580-0842-08 P 237 ml — — FDA listed —
Goodsense maximum strength Stomach Relief 528 1050 mg/30mL 50804-0154-04 Good 236 ml — — FDA listed —
CVS Stomach Relief Ultra Strength 525 mg/15mL 51316-0707-12 CVS 354 ml — — FDA listed —
Maximum Strength Stomach Relief 1050 mg/30mL 53041-0528-04 Guardian 236 ml — — FDA listed —
Ultra Strength Stomach Relief 525 mg/15mL 53041-0529-04 Guardian 236 ml — — FDA listed —
Stomach Relief Maximum Strength 1050 mg/30mL 53942-0558-26 Demoulas 237 ml — — FDA listed —
Maximum Strength Pink Bismuth 1050 mg/30mL 53943-0528-05 Discount 354 ml — — FDA listed —
Stomach Relief Ultra 525 mg/15mL 55319-0948-08 Family 237 ml — — FDA listed —
Kaopectate Max Peppermint Flavor Anti Diarrheal 525 mg/15mL 55505-0200-36 Kramer 236 ml — — FDA listed —
Kaopectate 525 mg/15mL 55505-0229-64 KRAMER 325 ml — — FDA listed —
Ultra Bismuth 525 mg/15mL 55910-0637-04 Dolgencorp, 118 ml — — FDA listed —
Stomach Relief Ultra 525 mg/15mL 55910-0837-08 Dolgencorp, 237 ml — — FDA listed —
QC Stomach Relief Regular Strength 525 mg/15mL 63868-0304-08 QUALITY 236 ml — — FDA listed —
Stomach Relief Ultra Strength 525 mg/15mL 63868-0813-08 QUALITY 237 ml — — Discontinued —
Stomach Relief Ultra 525 mg/15mL 63941-0737-04 Best 118 ml — — FDA listed —
WinCo FOODS Ultra Strength Stomach Relief 525 mg/15mL 67091-0363-24 WINCO 236 ml — — FDA listed —
DRx Choice Stomach Relief Regular Strength 525 mg/15mL 68163-0707-12 RARITAN 354 ml — — FDA listed —
Stomach Relief, Ultra Strength 1050 mg/30mL 68998-0558-28 Marc 354 ml — — FDA listed —
Max Strength Stomach Relief 1050 mg/30mL 69256-0528-04 Harris 236 ml — — FDA listed —
Pepto Bismol Ultra 525 mg/15mL 69423-0966-12 The 354 ml — — FDA listed —
Stomach Relief Maximum Strength 525 mg/15mL 69842-0229-12 CVS 355 ml — — FDA listed —
Ultra Strength Stomach Relief 525 mg/15mL 72476-0528-04 Retail 236 ml — — FDA listed —
Stomach Relief Ultra Strength 525 mg/15mL 72476-0737-08 Care 237 ml — — FDA listed —
Topcare Ultra Strength Stomach Relief 525 mg/15mLthis 76162-0022-04 Topco 236 ml — — FDA listed —
Stomach Relief - Maximum Strength 1050 mg/30mL 76281-0538-26 AptaPharma 237 ml — — FDA listed —
Stomach Relief, Maximum Strength 1050 mg/30mL 76281-0558-25 AptaPharma 177 ml — — FDA listed —
Quality Choice Ultra Strength Stomach Relief 525 mg/15mL 83324-0337-08 QUALITY 236 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 Pink
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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII 1678RKX8RT
    A synthetic red dye used to color tablets, capsules, and liquid medicines. It helps make pills visually distinct and easier to identify.
  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII L605B5892V
    A plant-derived thickener made from cellulose. It increases the medicine's thickness and helps it spread evenly, commonly used in gels, creams, and eye drops to improve texture and how the product coats or clings to surfaces.
  • 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 SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII O414PZ4LPZ
    A beta hydroxy acid derived from willow bark or synthesized chemically. In topical medicines, it acts as a keratolytic agent that helps soften and shed dead skin cells, improving penetration of active ingredients.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesbenzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum

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

LabelerTopco Associates, LLC
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code76162
First marketedJan 2022
Product typeHuman Otc Drug
Portfolio59 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

USE(S) relieves: diarrhea heartburn indigestion nausea upset stomach associated with these symptoms

⏱️ Dosage and Administration 68 words ▾

DIRECTIONS shake well before use mL = milliliter TBSP = tablespoon adults and children 12 years and over: 1 dose (1 TBSP or 15 mL) every 1/2 hour as needed do not exceed 8 doses (120 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of fluids to help prevent dehydration caused by diarrhea

⚠️ Warnings 73 words ▾

WARNINGS Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a rare but serious illness. Allergy alert: Contains salicylate.

Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products

📦 Storage and Handling 35 words ▾

OTHER INFORMATION each 15 mL or 1 TBSP contains: potassium 15 mg salicylate 236 mg sodium 5 mg protect from freezing avoid excessive heat (over 104 o F or 40 o C) dosage cup provided

🧪 Active Ingredient 9 words ▾

ACTIVE INGREDIENT(in each 15 mL) Bismuth subsalicylate 525 mg

🧪 Inactive Ingredients 26 words ▾

INACTIVE INGREDIENTS benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum

🎯 Purpose 6 words ▾

PURPOSE Upset stomach reliever and anti-diarrheal

📄 Do Not Use 15 words ▾

DO NOT USE IF YOU HAVE an ulcer bloody or black stool a bleeding problem

📄 Ask a Doctor Before Use If 13 words ▾

ASK A DOCTOR BEFORE USE IF YOU HAVE fever mucus in the stool

📄 Ask a Doctor or Pharmacist Before Use If 22 words ▾

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis

📄 When Using This Product 16 words ▾

WHEN USING THIS PRODUCT a temporary, but harmless darkening of the stool and/or tongue may occur

📄 Stop Use and Ask a Doctor If 24 words ▾

STOP USE AND ASK DOCTOR IF symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days

🤰 If Pregnant or Breast-Feeding 10 words ▾

IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.

📄 Keep Out of Reach of Children 20 words ▾

KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center immediately.

📄 Package Label / Principal Display Panel 84 words ▾

PRINCIPAL DISPLAY PANEL NDC 76162-022-04 COMPARE TO PEPTO-BISMOL® ULTRA STRENGTH ACTIVE INGREDIENT* TopCare ULTRA STRENGTH Stomach Relief BISMUTH SUBSALICYLATE 525 mg per 15 mL UPSET STOMACH RELIEVER/ANTIDIARRHEAL 5 SYMPTOM DIGESTIVE RELIEF Heartburn Indigestion Nausea Upset stomach Diarrhea 8 FL OZ (236 mL) NDC 76162-022-05 COMPARE TO PEPTO-BISMOL ® ULTRA STRENGTH ACTIVE INGREDIENT* TopCare ULTRA STRENGTH Stomach Relief BISMUTH SUBSALICYLATE 525 mg per 15 mL UPSET STOMACH RELIEVER/ANTIDIARRHEAL 5 SYMPTOM DIGESTIVE RELIEF Heartburn Indigestion Nausea Upset stomach Diarrhea 12 FL OZ (354 mL) 528-08-topco.jpg 528.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 Topcare Ultra Strength Stomach Relief (this brand).

Top reported reactions

Nausea93
Vomiting76
Diarrhoea70
Abdominal Pain60
Pain53
Constipation48
Abdominal Distension43

Reporter sex

0 reports

Serious outcomes

Hospitalization264
Death125
Disabling39
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 45 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.

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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 354 ml (76162-0022-05). Each has its own NDC and its own page — see the package list near the top of this page.
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.
← 76162-0020-40 · TOPCO 76162-0024-01 · 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.