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Buscapina Acetaminophen, Caffeine, Pyrilamine Maleate 500 mg; 60 mg; 15 mg Tablet, Coated, 24-count — NDC 69729-0130-24 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Buscapina Acetaminophen, Caffeine, Pyrilamine Maleate 500 mg; 60 mg; 15 mg Tablet, Coated, 24-count — NDC 69729-130-24 (Billing 69729-0130-24)

by OPMX LLC · 24 TABLET, COATED in 1 BOTTLE

This is a package of 24 tablets of Buscapina Acetaminophen, Caffeine, Pyrilamine Maleate 500 mg; 60 mg; 15 mg Tablet, Coated from OPMX LLC, marketed since Jan 2018 and currently FDA-listed. It is this product's only package size.

NDC 69729-0130-24
🏷️ FDA NDC (as labeled) 69729-130-24 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 69729-130-24 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69729 labeler · 130 product · 24 package
Package marketed since
Jan 5, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0856828008007
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69729-130-24
Product NDC 69729-130
11-digit billing NDC 69729013024
RxCUI 1597298
UNII 362O9ITL9D, 3G6A5W338E, R35D29L3ZA
UPC 0856828008007
Application # M012
SPL Set ID 10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b
Established class (EPC) Central Nervous System Stimulant; Methylxanthine
Physiologic effect Central Nervous System Stimulation
Chemical class Xanthines
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-01-05
Route ORAL
Dosage form TABLET, COATED
Substance ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
Quick answers
  • RxCUI (RxNorm): 1597298
Why two NDCs? The FDA registers this code as 69729-130-24 — 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 → 69729-0130-24. 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 Anilides class.

Drug family (ATC) Anilides
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 is this product?

Buscapina is an over-the-counter coated tablet taken by mouth that combines three active ingredients. Acetaminophen is typically used to reduce pain and fever. Caffeine is a central nervous system stimulant commonly included in pain relief products to enhance their effects. Pyrilamine maleate is an antihistamine often added to cold and pain formulas. This combination is marketed as an OTC monograph product, meaning it follows established FDA guidelines for its drug category rather than undergoing individual approval.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
7
Nutrient depletion considerations

Acetaminophen, Caffeine, Pyrilamine may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen, Caffeine, Pyrilamine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 eachPer 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
69729-0130-24 You're viewing this Main listing 24 TABLET, COATED in 1 BOTTLE 2018-01-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Midol Complete 500 mg/1; 60 mg/1; 15 mg 00280-8005-16 Bayer 16 tablets — — FDA listed —
Midol Complete Gelcaps 60 mg/1; 15 mg/1; 500 mg 00280-8015-24 Bayer 24 tablets — — FDA listed —
Menstrual Relief Maximum Strength 500 mg/1; 60 mg/1; 15 mg 00363-0252-21 Walgreen 8 tablets — — Discontinued —
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg 500 mg/1; 60 mg/1; 15 mg 00363-2310-24 WALGREENS 24 tablets — — FDA listed —
Menstrual Pain Relief 500 mg/1; 60 mg/1; 15 mg 00363-3900-10 Walgreen 40 tablets — — Discontinued —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 00363-3909-21 Walgreen 8 tablets — — FDA listed —
Menstrual Complete Pain Relief 500 mg/1; 60 mg/1; 15 mg 00363-9390-10 Walgreen 40 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 00924-6010-02 Acme 100 tablets — — FDA listed —
Multi-Symptom Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 11673-0363-64 TARGET 40 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 11673-0390-10 Target 40 tablets — — FDA listed —
Menstrual Complete Maximum Strength 500 mg/1; 60 mg/1; 15 mg 11822-0390-01 Rite 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 11822-3900-01 Rite 40 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 21130-0930-10 Better 40 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 29485-7964-02 Lil' 50 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 30142-0390-10 Kroger 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 36800-0391-08 Topco 24 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 37808-0389-10 H 40 tablets — — FDA listed —
Menstrual Relief Maximum Strength 500 mg/1; 60 mg/1; 15 mg 41163-0390-10 United 40 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 41163-0391-10 United 40 tablets — — FDA listed —
Comfort-Time 500 mg/1; 60 mg/1; 15 mg 49483-0347-24 Time 24 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 50269-0007-06 JC 12 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 50269-0009-06 JC 24 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 50804-0990-08 Geiss, 24 tablets — — FDA listed —
Menstrual Complete Maximum Strength 500 mg/1; 60 mg/1; 15 mg 50844-0390-19 L.N.K. 8 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 50844-0399-08 L.N.K. 24 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 51316-0390-10 CVS 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 53943-0390-10 Discount 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 55319-0301-21 Family 8 tablets — — FDA listed —
Dolex Fem 500 mg/1; 60 mg/1; 15 mg 55758-0326-25 Pharmadel 24 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 55910-0123-10 DOLGENCORP, 40 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 59779-0930-08 CVS 8 tablets — — FDA listed —
Menstrual Complete Maximum Strength 500 mg/1; 60 mg/1; 15 mg 63868-0032-24 CHAIN 24 tablets — — FDA listed —
Midol Complete, Travel BASIX 500 mg/1; 60 mg/1; 15 mg 66715-6445-02 Lil' 4 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 66715-9745-02 Lil' 4 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 67091-0334-40 WinCo 40 tablets — — FDA listed —
Midol 500 mg/1; 60 mg/1; 15 mg 67751-0145-01 Navajo 4 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 69168-0470-06 Allegiant 120 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 69517-0130-20 Healthlife 20 tablets — — FDA listed —
Buscapina 500 mg/1; 60 mg/1; 15 mgthis 69729-0130-24 OPMX 24 tablets — — FDA listed —
Buscapina 500 mg/1; 60 mg/1; 15 mg 69729-0131-72 OPMX 2 tablets — — FDA listed —
Buscapina 15 mg/1; 500 mg/1; 60 mg 69729-0132-06 OPMX 2 tablets — — FDA listed —
Buscapina 15 mg/1; 500 mg/1; 60 mg 69729-0818-50 OPMX 2 tablets — — FDA listed —
Midol Complete 15 mg/1; 500 mg/1; 60 mg 70264-0012-01 R 100 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 70692-0131-24 Strive 24 tablets — — FDA listed —
Menstrual Complete 60 mg/1; 15 mg/1; 500 mg 72090-0026-02 Pioneer 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 79481-0390-01 Meijer 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 79903-0266-40 WALMART 40 tablets — — FDA listed —
FLO PMS Complete 500 mg/1; 60 mg/1; 15 mg 83049-0489-08 O 24 tablets — — FDA listed —
Menstrual Pain Relief Complete 500 mg/1; 60 mg/1; 15 mg 83059-0006-01 Shield 15 tablets — — Discontinued —
Menstrual Pain Relief Complete 500 mg/1; 60 mg/1; 15 mg 83059-0105-01 Shield 15 tablets — — FDA listed —
Menstrual Pain Relief Complete 500 mg/1; 60 mg/1; 15 mg 83059-0119-08 Shield 80 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 83324-0017-24 Chain 24 tablets — — FDA listed —
Syncol Max 500 mg/1; 60 mg/1; 15 mg 83393-0390-02 Laboratorios 12 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 85237-1841-01 Select 2 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 41226-0348-44 Kroger 40 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.

Availability & generic status

🏛️
2018
On the market since
Jan 2018
📍
2026
Currently FDA-listed
8 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 white
ShapeCapsule
Size17 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statesColloidal silicon dioxide Hypromellose Magnesium stearate Microcrystalline cellulose Polyethylene glycol Polyvinyl pyrrolidone Pregelatinized starch Titanium dioxide Talc

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

LabelerOPMX LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code69729
First marketedJan 2018
Product typeHuman Otc Drug
Portfolio87 products on file

More NDCs from OPMX LLC labeler code 69729

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 🧪 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 22 words ▾

Uses For the temporary relief of these symptoms associated with menstrual periods Cramps Bloating Water- weight gain Headache Backache Muscle aches Fatigue

⏱️ Dosage and Administration 38 words ▾

Directions Do not exceed recommended dosage. Adults and children 12 years and over: Take 2 tablets with water. Repeat every 6 hours, as needed. Do not exceed 6 tablets per day Children under 12 years: Consult a doctor

⚠️ Warnings 87 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 tablets in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy warning: Acetaminophen may cause severe skin or severe allergic reactions.

Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock If a skin or general allergic reaction occurs, stop use and seek medical help right away.

🧪 Active Ingredient 13 words ▾

Active Ingredients (in each caplet) Acetaminophen 500mg, Caffeine 60mg, and Pyrilamine maleate 15mg

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients Colloidal silicon dioxide Hypromellose Magnesium stearate Microcrystalline cellulose Polyethylene glycol Polyvinyl pyrrolidone Pregelatinized starch Titanium dioxide Talc

🎯 Purpose 7 words ▾

Purpose Pain Reliever, Diuretic, Antihistamine, Multi-Symptom Relief

📄 Do Not Use 43 words ▾

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients

📄 Ask a Doctor Before Use If 30 words ▾

Ask a doctor before use if you have Liver disease Glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis

📄 Ask a Doctor or Pharmacist Before Use If 20 words ▾

Ask a doctor or pharmacist before use if you are Taking the blood thinning drug warfarin Taking sedatives or tranquilizers

📄 When Using This Product 72 words ▾

When using this product you may get drowsy avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat. The recommended dose of this product contains aboout as much caffeine as a cup of coffee.

📄 Stop Use and Ask a Doctor If 35 words ▾

Stop use and ask a doctor if new symptoms appear redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 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 44 words ▾

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Questions or Comments 60 words ▾

Other Information Store at room temperature 68-77° F (20-25°C) TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Questions or comments? Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST PLEASE REFER TO LEAFLET FOR INSTRUCTIONS IN SPANISH CONSULTE EL FOLLETO PARA INSTRUCCIONES EN ESPAÑOL

📄 Package Label / Principal Display Panel 50 words ▾

Principal display panel 24 NDC 69729-130-24 Buscapina Acetaminophen 500 mg Caffeine 60 mg Pyrilamine Malete 15 mg Pain Reliever Cramps/ Cólicos Bloatinng/ Hinchazón Fatigue/ Fatiga Headache/ Dolor de cabeza Backache/ Dolor de espalda Licenced by: Gute Besserung Hauser LLC Exclusively distributed by: OPMX Chula Vista, CA 91910 Phone: 619-600-5632 24

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 Buscapina (this brand).

Top reported reactions

Abdominal Pain24
Vomiting21
Diarrhoea17
Nausea17
Asthenia16
Abdominal Pain Upper15
Mucosal Inflammation15

Age at onset

Infant1
Adolescent2
Adult7
Elderly7

Reporter sex

145 reports
Male · 37%
Female · 63%

Serious outcomes

Hospitalization88
Death41
Life-threatening11
Disabling4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13 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 OPMX LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
OPMX 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.
← 69729-0123-12 · OPMX 69729-0131-72 · OPMX →
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.