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Equaline Stomach Relief Bismuth subsalicylate 525 mg/30mL Liquid, 236 mL — NDC 41163-0535-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Equaline Stomach Relief Bismuth subsalicylate 525 mg/30mL Liquid, 236 mL — NDC 41163-535-04 (Billing 41163-0535-04)

by UNITED NATURAL FOODS, INC. DBA UNFI · 236 mL in 1 BOTTLE

This is a package of 236 mL of Equaline Stomach Relief Bismuth subsalicylate 525 mg/30mL Liquid from UNITED NATURAL FOODS, INC. DBA UNFI, marketed since May 2024 and currently FDA-listed. It is this product's only package size.

NDC 41163-0535-04
🏷️ FDA NDC (as labeled) 41163-535-04 billing pads the product segment with a zero
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) 41163-535-04
Product NDC 41163-535
11-digit billing NDC 41163053504
NCPDP billing unit ML — per mL (volume)
RxCUI 308762
UNII 62TEY51RR1
UPC 0041163471368
Application # part335
SPL Set ID f2ef3cc3-4628-4e55-ad55-4887b203c5b2
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 2024-05-13
Route ORAL
Dosage form LIQUID
Substance BISMUTH SUBSALICYLATE

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

GPI-14 47300010001805
GCN Seq No 002858
GCN 26970
HICL code 001246
Ingredient (HICL) Bismuth Subsalicylate
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6D
Therapeutic class — specific (HIC3) Antidiarrheals
AHFS code 56:04.00.00
AHFS class Antacids And Adsorbents
FDB label name EQL STOMACH RLF 262 MG/15 ML
FDB brand name Stomach Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 002858
  • GCN: 26970
  • GPI-14 (Medi-Span): 47300010001805
  • HICL (First Databank): 001246
  • AHFS class code: 56:04.00.00
  • RxCUI (RxNorm): 308762
Why two NDCs? The FDA registers this code as 41163-535-04 — 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 → 41163-0535-04. 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

Label name EQL STOMACH RLF 262 MG/15 ML Ingredient Bismuth Subsalicylate
📗 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.
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
41163-0535-04 You're viewing this Main listing 236 mL in 1 BOTTLE 2024-05-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Stomach Relief Regular Strength 525 mg/30mL 62011-0435-01 Strategic 237 ml $0.011 — Discontinued —
Stomach Relief Regular Strength 525 mg/30mL 70677-0094-01 Strategic 237 ml $0.011 — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 00536-1286-36 Rugby 237 ml $0.012 — Availability likely —
Stomach Relief Regular Strength 525 mg/30mL 70000-0698-01 CARDINAL 236 ml $0.013 — Availability likely —
Foster and Thrive Regular Strength Stomach Relief 527 525 mg/30mL 70677-1191-01 Strategic 236 ml $0.013 — Availability likely —
Quality Choice Regular Strength Stomach Relief 525 mg/30mL 83324-0020-08 Chain 236 ml $0.013 — Availability likely —
QCH Stomach Relief 535 525 mg/30mL 83324-0022-08 Chain 236 ml $0.013 — Availability likely —
GNP Stomach Relief 525 mg/30mL 46122-0703-26 Amerisource 118 ml $0.017 — Availability likely —
Stomach Relief Original Strength 525 mg/30mL 70000-0044-01 Cardinal 118 ml $0.017 — Availability likely —
Soothe 525 mg/30mL 00363-0073-08 Walgreens 237 ml — — FDA listed —
Soothe 525 mg/30mL 00363-0736-16 Walgreens 473 ml — — FDA listed —
Stomach Relief 525 mg/30mL 00363-7024-16 Walgreens 473 ml — — FDA listed —
Soothe 525 mg/30mL 00363-7240-08 Walgreens 237 ml — — FDA listed —
5-Symptom Digestive Relief 525 mg/30mL 11673-0291-06 TARGET 236 ml — — FDA listed —
Digestive Relief Regular Strength 525 mg/30mL 11673-0372-08 TARGET 236 ml — — FDA listed —
up and up digestive relief 525 mg/30mL 11673-0706-08 Target 236 ml — — FDA listed —
Digestive Relief Regular Strength 525 mg/30mL 11673-0724-16 TARGET 473 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 11822-2910-07 Rite 473 ml — — FDA listed —
Rite Aid Regular Strngth Pink Bismuth 525 mg/30mL 11822-7016-06 RITE 473 ml — — FDA listed —
RITE AID Regular Strength Pink Bismuth 525 mg/30mL 11822-7060-03 RITE 2 bottles — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 17856-1286-01 ATLANTIC 50 cups — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 17856-8286-01 Atlantic 50 cups — — FDA listed —
SIGNATURE CARE Regular Strength 525 mg/30mL 21130-0182-12 SAFEWAY 354 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 21130-0624-08 Safeway, 237 ml — — FDA listed —
Kroger Regular Strength Pink Bismuth 525 mg/30mL 30142-0608-08 KROGER 236 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 30142-0624-08 The 237 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 30142-0680-01 The 2 bottles — — FDA listed —
TopCare Stomach Relief Regular Strength 525 mg/30mL 36800-0338-08 TOPCO 236 ml — — FDA listed —
TopCare Regular Strength 525 mg/30mL 36800-0661-08 TOPCO 236 ml — — FDA listed —
Topcare Stomach Relief cherry 525 mg/30mL 36800-0769-04 Topco 236 ml — — FDA listed —
Pepto-Bismol 525 mg/30mL 37000-0438-04 The 118 ml — — FDA listed —
Pepto-Bismol Cherry 525 mg/30mL 37000-0439-08 The 236 ml — — FDA listed —
HEB Stomach Relief Regular Strength 525 mg/30mL 37808-0607-08 H 236 ml — — FDA listed —
Equaline Stomach Relief 525 mg/30mLthis 41163-0535-04 UNITED 236 ml — — FDA listed —
Equaline Stomach Relief 525 mg/30mL 41163-0936-04 UNITED 237 ml — — FDA listed —
meijer stomach relief regular strength 525 mg/30mL 41250-0670-12 MEIJER 354 ml — — FDA listed —
meijer stomach relief regular strength 525 mg/30mL 41250-0671-16 MEIJER 473 ml — — FDA listed —
PUBLIX Regular Strength Pink Bismuth 525 mg/30mL 41415-0706-08 PUBLIX 236 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 49035-0725-08 EQUATE 237 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 49580-0624-06 P 473 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 49580-0724-01 P 473 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 49580-0736-08 P 237 ml — — Discontinued —
GS Stomach Relief 525 mg/30mL 50804-0122-04 Good 236 ml — — FDA listed —
Pink-Bismuth 262 mg/15mL 53041-0527-03 Guardian 118 ml — — FDA listed —
Bismutina 525 mg/30mL 53145-0475-08 Menper 240 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 53942-0557-28 Demoulas 354 ml — — FDA listed —
Pink Bismuth Original 525 mg/30mL 53943-0529-06 Discount 473 ml — — FDA listed —
Pink Bismuth Regular Strength 525 mg/30mL 53943-0535-06 Discount 473 ml — — FDA listed —
Stomach Relief 525 mg/30mL 55319-0560-08 Family 237 ml — — FDA listed —
Stomach Relief 525 mg/30mL 55319-0951-08 Family 237 ml — — FDA listed —
Kaopectate Vanilla Flavor Anti Diarrheal 262 mg/15mL 55505-0198-36 Kramer 236 ml — — FDA listed —
Kaopectate Peppermint Flavor Anti Diarrheal 262 mg/15mL 55505-0199-36 Kramer 236 ml — — FDA listed —
Rapidol Stomach Relief 525 mg/30mL 55758-0331-08 Pharmadel 240 ml — — Discontinued —
Stomach Relief Regular Strength 525 mg/30mL 55910-0436-08 Dolgencorp, 237 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 55910-0624-04 Dolgencorp, 118 ml — — FDA listed —
Stomach Relief 525 mg/30mL 57243-0557-26 Consumer 237 ml — — FDA listed —
CVS Health Anti-Diarrheal Vanilla 262 mg/15mL 59779-0883-12 CVS 355 ml — — FDA listed —
QC Stomach Relief Cherry Flavor 525 mg/30mL 63868-0305-08 QUALITY 236 ml — — FDA listed —
QC Anti Diarrheal Vanilla Regular Flavor 262 mg/15mL 63868-0339-12 QUALITY 355 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 63868-0907-08 QUALITY 237 ml — — Discontinued —
Stomach Relief Regular Strength 525 mg/30mL 63941-0724-04 Best 118 ml — — FDA listed —
Stomach Circle K 525 mg/30mL 66715-5555-04 Lil' 237 ml — — FDA listed —
Stomach Lil Drug Store Products 525 mg/30mL 66715-6855-04 Lil' 237 ml — — FDA listed —
Stomach Relief, Caseys 4good 525 mg/30mL 66715-8355-04 Lil' 237 ml — — FDA listed —
Stomach Relief, 24-7 Life 525 mg/30mL 66715-8554-02 Lil' 237 ml — — FDA listed —
WinCo FOODS Stomach Relief 525 mg/30mL 67091-0362-23 WINCO 236 ml — — FDA listed —
Premier Value Diarrhea Relief Vanilla Flavor 262 mg/15mL 68016-0317-12 PHARMACY 355 ml — — FDA listed —
Regular Strength Pink Bismuth 525 mg/30mL 68163-0706-04 Raritan 118 ml — — FDA listed —
Stomach Relief 525 mg/30mL 69256-0527-04 Harris 236 ml — — FDA listed —
Stomach Relief regular strength 525 mg/30mL 69842-0227-04 CVS 118 ml — — FDA listed —
Maximum strength Stomach Relief 525 mg/30mL 69842-0528-04 CVS 236 ml — — FDA listed —
regular strength pink bismuth 525 mg/30mL 69842-0766-12 CVS 354 ml — — FDA listed —
AMAZON Regular Strength 525 mg/30mL 72288-0706-16 AMAZON.COM 473 ml — — FDA listed —
Regular Strength Stomach Relief 525 mg/30mL 72476-0527-06 Retail 473 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 72476-0724-08 Care 237 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 72476-0736-08 Care 237 ml — — FDA listed —
Stomach Relief - Regular Strength 525 mg/30mL 76281-0537-25 AptaPharma 177 ml — — FDA listed —
Bismuth Subsalicylate Suspension Regular Strength 525 mg/30mL 76281-0557-28 AptaPharma 354 ml — — FDA listed —
Stomach Relief 525 mg/30mL 79903-0311-16 WALMART 473 ml — — FDA listed —
Dye Free Regular Strength Stomach Relief 525 mg/30mL 79903-0427-16 Walmart 473 ml — — FDA listed —
Bismuth Subsalicylate Suspension Regular Strength 525 mg/30mL 81522-0557-28 FSA 354 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 82501-7240-08 Gobrands, 237 ml — — FDA listed —
Revasol Peptic Relief 525 mg/30mL 84379-0283-04 Rnv 118 ml — — FDA listed —
Dr. Simi Stomach Relief 525 mg/30mL 85786-0802-12 Farmacias 354 ml — — FDA listed —
Stomach Relief 525 mg/30mL 85828-0791-07 Grocery 473 ml — — FDA listed —
Medique Diotame Instydose 525 mg/30mL 47682-0670-69 Unifirst 180 ml — — FDA listed —
Green Guard Instydose Upset Stomach Relief 525 mg/30mL 47682-0770-69 Unifirst 180 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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 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.

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.

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

LabelerUNITED NATURAL FOODS, INC. DBA UNFI
FDA applicationpart335 (OTC MONOGRAPH DRUG)
Labeler code41163
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio211 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 associate with these symptoms

⏱️ Dosage and Administration 73 words ▾

DIRECTIONS shake well before use mL = milliliter TBSP = tablespoon adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as needed do not exceed 8 doses (16 TBSP or 240 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 30 mL or 2 TBSP contains: potassium 25 mg salicylate 260 mg sodium 8 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 30 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 37 words ▾

PRINCIPAL DISPLAY PANEL NDC 41163-535 Compare to cherry Pepto-Bismol® active ingredient* EQUALINE stomach relief Liquid bismuth subsalicylate (Upset stomach reliever/Anti-diarrheal) soothing relief for: heartburn indigestion nausea upset stomach diarrhea Cherry Flavor 16 FL OZ (473 mL) 520-equ.jpg

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) — 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

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 UNITED NATURAL FOODS, INC. DBA UNFI. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
UNITED NATURAL FOODS, INC. DBA UNFI 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.
← 41163-0529-08 · United 41163-0536-30 · United →
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.