Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Pepto-Bismol Bismuth subsalicylate 262 mg Tablet, 40-count — NDC 58933-476-03 (Billing 58933-0476-03)
by Procter & Gamble Manufactura S de RL de CV · 1 BOTTLE in 1 CARTON / 40 TABLET in 1 BOTTLE
This is a package of 40 tablets of Pepto-Bismol Bismuth subsalicylate 262 mg Tablet from Procter & Gamble Manufactura S de RL de CV, marketed since Jun 2004 and currently FDA-listed.
NDC 58933-0476-03
🏷️ FDA NDC (as labeled)
58933-476-03
billing pads the product segment with a zero
This package
Contains40-count
Pack sizes4 compare ↓
Product page 58933-0476-01
Also comes in:
2 tablets 58933-476-01
24 tablets 58933-476-02
17852 tablets 58933-476-12
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 58933-476-03 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 58933 labeler · 476 product · 03 package
- Package marketed since
- Jun 30, 2004
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 5893347603 5
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
58933-476-03
Product NDC
58933-476
11-digit billing NDC
58933047603
UNII
62TEY51RR1
Application #
M008
SPL Set ID
66d9d631-ba73-3ce4-e053-2a91aa0a1cc4
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
2004-06-30
Route
ORAL
Dosage form
TABLET
Substance
BISMUTH SUBSALICYLATE
Quick answers
- RxCUI (RxNorm): 308760
Why two NDCs?
The FDA registers this code as 58933-476-03 — 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 → 58933-0476-03. 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 5, 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 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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📖 What it is MedlinePlus · NLM
Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.
Read the full MedlinePlus article ↗📗 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Bismuth Subsalicylate (OTC drug) — 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 5, 2026
💬 Questions about Bismuth subsalicylate?
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 5, 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 |
|---|---|---|---|---|
| 58933-0476-01 58933-476-01 Main listing | 1 BLISTER PACK in 1 POUCH / 2 TABLET in 1 BLISTER PACK | 2004-06-30 | — | Active |
| 58933-0476-02 58933-476-02 | 1 BOTTLE in 1 CARTON / 24 TABLET in 1 BOTTLE | 2004-06-30 | — | Active |
| 58933-0476-03 You're viewing this | 1 BOTTLE in 1 CARTON / 40 TABLET in 1 BOTTLE | 2004-06-30 | — | Active |
| 58933-0476-12 58933-476-12 | 17852 TABLET in 1 BAG | 2004-06-30 | — | Active |
Pack size FAQ
What quantity is in this package?
This is a 40-count package — 1 bottle in 1 carton / 40 tablet in 1 bottle.
How does this package differ from NDC 58933-0476-01?
Both are Pepto-Bismol Bismuth subsalicylate 262 mg Tablet — the drug itself is identical. This page's package is the 40-count one, while NDC 58933-0476-01 is the 2 tablets package.
What NDC number is used to bill for this package of Pepto-Bismol Bismuth subsalicylate 262 mg Tablet?
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| GNP Pink Bismuth 262 mg 24385-0017-58 | Amerisource | 40 tablets | $0.093 | — | Availability likely | — |
| Bismuth Subsalicylate 262 mg 70000-0594-01 | LEADER/ | 24 tablets | $0.093 | — | Availability likely | — |
| Foster and Thrive Stomach Relief 262 mg 70677-1082-01 | Strategic | 40 tablets | $0.093 | — | Availability likely | — |
| Stomach Relief 262 mg 83324-0060-40 | Chain | 40 tablets | $0.093 | — | Availability likely | — |
| Walgreen 262 mg 00363-9125-40 | WALGREEN | 40 tablets | — | — | FDA listed | — |
| up and up 5-symptom digestive relief 262 mg 11673-0122-48 | Target | 48 tablets | — | — | FDA listed | — |
| up and up 5-symptom digestive relief 262 mg 11673-0125-20 | Target | 40 tablets | — | — | FDA listed | — |
| 5-Symptom Digestive Relief 262 mg 11673-0880-44 | TARGET | 40 tablets | — | — | FDA listed | — |
| Rite Aid Digestive Relief 262 mg 11822-1254-00 | RITE | 40 tablets | — | — | FDA listed | — |
| Digestive Relief 262 mg 21130-0125-40 | SAFEWAY | 40 tablets | — | — | FDA listed | — |
| Kroger Digestive Relief 262 mg 30142-0524-24 | KROGER | 24 tablets | — | — | FDA listed | — |
| Topco Stomach Relief 262 mg 36800-0104-28 | Topco | 40 tablets | — | — | FDA listed | — |
| Stomach Relief 262 mg 37808-0346-08 | H | 24 tablets | — | — | FDA listed | — |
| Equaline Stomach Relief 262 mg 41163-0123-28 | UNITED | 40 tablets | — | — | FDA listed | — |
| meijer stomach relief 262 mg 41250-0324-40 | Meijer | 40 tablets | — | — | FDA listed | — |
| Stomach reliever 262 mg 42507-0707-28 | Hyvee | 40 tablets | — | — | FDA listed | — |
| Stomach Relief 262 mg 49035-0346-10 | Wal-Mart | 40 tablets | — | — | FDA listed | — |
| Kaopectate 262 mg 55505-0197-07 | Kramer | 28 tablets | — | — | FDA listed | — |
| POCKET PEPTO Pepto Bismol 262 mg 58933-0017-12 | Procter | 12 tablets | — | — | FDA listed | — |
| Pepto-Bismol 262 mgthis 58933-0476-03 | Procter | 40 tablets | — | — | FDA listed | — |
| QC Pink Bismuth 262 mg 63868-0171-40 | QUALITY | 40 tablets | — | — | FDA listed | — |
| Stomach Relief 262 mg 63868-0691-40 | CHAIN | 40 tablets | — | — | Discontinued | — |
| Anti-Diarrheal 262 mg 66715-6841-04 | Lil' | 24 tablets | — | — | FDA listed | — |
| Stomach relief 262 mg 69842-0172-12 | CVS | 24 tablets | — | — | FDA listed | — |
| Bismuth Subsalicylate 262 mg 69842-0346-12 | CVS | 24 tablets | — | — | FDA listed | — |
| AMAZON Digestive Relief 262 mg 72288-0125-40 | AMAZON.COM | 40 tablets | — | — | FDA listed | — |
| Pepto-Bismol 262 mg 76420-0490-24 | ASCLEMED | 24 tablets | — | — | FDA listed | — |
| Stomach Relief 262 mg 63868-0622-30 | CDMA- | 30 tablets | — | — | FDA listed | — |
| Topcare Stomach Relief Original Strength 262 mg 76162-0001-85 | TopCo | 30 tablets | — | — | FDA listed | — |
| CVS Stomach Relief 262 mg 51316-0124-48 | CVS | 48 tablets | — | — | FDA listed | — |
| Bismuth 262 mg 69168-0046-69 | Allegiant | 12 tablets | — | — | FDA listed | — |
| Stomach Relief 262 mg 41226-0475-42 | Kroger | 24 tablets | — | — | FDA listed | — |
| Stomach Relief 262 mg 37835-0207-48 | Bi-Mart | 48 tablets | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2004
On the market since
Jun 2004
📍
2026
Currently FDA-listed
22 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.
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Color
pink
ShapeOval
ImprintPeptoBismol
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.
- FDA label on DailyMed · label index refreshed Oct 5, 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.
🧪 Avoiding an ingredient? See Bismuth Subsalicylate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
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 5, 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
LabelerProcter & Gamble Manufactura S de RL de CV
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code58933
First marketedJun 2004
Product typeHuman Otc Drug
Portfolio17 products on file
More NDCs from Procter & Gamble Manufactura S de RL de CV labeler code 58933
- Crest Bubblegum Sodium Fluoride 1.5 mg/g Paste, Dentifrice NDC 58933-047-42
- Crest Strawberry Sodium Fluoride 1.5 mg/g Paste, Dentifrice NDC 58933-048-42
- Kids Crest Cavity Protection Sparkle Fun Sodium Fluoride 1.5 mg/g Paste, Dentifrice NDC 58933-049-01
- Crest Strawberry Sodium Fluoride 1.5 mg/g Paste, Dentifrice NDC 58933-171-42
- Pepto-Bismol Diarrhea Bismuth subsalicylate 525 mg Tablet NDC 58933-391-12
- Pepto Kids Calcium Carbonate 400 mg Tablet, Chewable NDC 58933-446-24
- Pepto-Bismol ULTRA Bismuth subsalicylate 525 mg Tablet NDC 58933-478-12
- Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Phenylephrine HCl Kit NDC 58933-542-16
- Vicks VapoRub Camphor (synthetic), Eucalyptus oil, and Menthol .048 g/g; .012 g/g; .026 g/g Ointment NDC 58933-544-01
- Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl 500 mg/5g; 10 mg/5g; 20 mg/5g Powder, For Solution NDC 58933-550-01
- Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl 10 mg/5g; 650 mg/5g; 25 mg/5g Powder, For Solution NDC 58933-551-01
- Vicks DayQuil HOT REMEDY Cold and Flu Acetaminophen, Dextromethorphan HBr 500 mg/5g; 20 mg/5g Powder, For Solution NDC 58933-552-01
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 ▾
Uses relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness
⏱️ Dosage and Administration ▾
Directions • swallow with water, do not chew • adults and children 12 years and over: 2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea 2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 caplets) in 24 hours • use until diarrhea stops but not more than 2 days • children under 12 years: ask a doctor • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
⚠️ Warnings ▾
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 Do not use if you have an ulcer a bleeding problem bloody or black stool Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur Stop use and ask a doctor if symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days If pregnant or breast feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information each caplet contains: calcium 27 mg salicylate 99 mg low sodium avoid excessive heat (over 104°F or 40°C)
🧪 Active Ingredient ▾
Active ingredient (in each caplet) Bismuth subsalicylate 262 mg
🧪 Inactive Ingredients ▾
Inactive ingredients calcium carbonate, D&C red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate
🎯 Purpose ▾
Purpose Upset stomach reliever and antidiarrheal
📄 Do Not Use ▾
Do not use if you have an ulcer a bleeding problem bloody or black stool
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have fever mucus in the stool
📄 Ask a Doctor or Pharmacist Before Use If ▾
Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis
📄 When Using This Product ▾
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days
🤰 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.
📄 Questions or Comments ▾
Questions? 1-800-717-3786
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 24 Caplet Carton Pepto Bismol ® Bismuth Subsalicylate Upset Stomach Reliever/ Antidiarrheal 5 SYMPTOM RELIEF NAUSEA HEARTBURN INDIGESTION UPSET STOMACH DIARRHEA 24 CAPLETS 476
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 ↗
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 Bismuth subsalicylate — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 38%
Female · 62%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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) | — 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 Procter & Gamble Manufactura S de RL de CV. 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 3 other package presentations of this same product, including 2 tablets (58933-0476-01), 24 tablets (58933-0476-02), 17852 tablets (58933-0476-12). 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?
Procter & Gamble Manufactura S de RL de CV 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.