Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
DOLONEURO-TROPAS Acetaminophen, Caffeine 500 mg; 65 mg Tablet, Film Coated — NDC 69729-795-80 (Billing 69729-0795-80)
by OPMX LLC · 20 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK
This is a package of DOLONEURO-TROPAS Acetaminophen, Caffeine 500 mg; 65 mg Tablet, Film Coated from OPMX LLC, marketed since Jan 2026 and currently FDA-listed.
NDC 69729-0795-80
🏷️ FDA NDC (as labeled)
69729-795-80
billing pads the product segment with a zero
This package
Contains4 tablet, film coated in 1 blister pack
Pack sizes2 compare ↓
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 69729-795-80 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 69729 labeler · 795 product · 80 package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 6972979580 3
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
69729-795-80
Product NDC
69729-795
11-digit billing NDC
69729079580
Application #
M013
SPL Set ID
4c4b0d8c-3195-7d7b-e063-6294a90a8c42
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
2026-01-29
Route
ORAL
Dosage form
TABLET, FILM COATED
Substance
ACETAMINOPHEN; CAFFEINE
Why two NDCs?
The FDA registers this code as 69729-795-80 — 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 → 69729-0795-80. 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
🧪 What is this product?
This is an over-the-counter tablet taken by mouth that combines acetaminophen and caffeine. Acetaminophen is commonly used to reduce fever and relieve mild to moderate pain. Caffeine is a stimulant typically included in such products to enhance alertness and to work alongside pain relievers in combination formulas. This is an OTC monograph drug, meaning it is marketed under FDA's established rules for its category rather than through an individual product application.
Patient education
Supplement & herbal interactions
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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about Acetaminophen, Caffeine?
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.
Try another pack size:
12 tablets
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 8, 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 |
|---|---|---|---|---|
| 69729-0795-80 You're viewing this | 20 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK | 2026-01-29 | — | Active |
| 69729-0795-24 69729-795-24 Main listing | 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2025-04-01 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 20 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of DOLONEURO-TROPAS Acetaminophen, Caffeine 500 mg; 65 mg Tablet, Film Coated?
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 |
|---|---|---|---|---|---|---|
| Tension Headache 500 mg/1; 65 mg 70000-0159-01 | Cardinal | 24 tablets | $0.062 | — | Availability likely | — |
| Excedrin Tension Headache 500 mg/1; 65 mg 00067-8139-01 | Haleon | 24 tablets | — | — | FDA listed | — |
| PANADOL Extra 500 mg/1; 65 mg 00135-0620-01 | Haleon | 24 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 00363-0572-31 | Walgreen | 80 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 00363-7213-10 | WALGREENS | 100 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 11673-0839-01 | TARGET | 100 tablets | — | — | FDA listed | — |
| Tension Headache Aspirin-Free 500 mg/1; 65 mg 11822-0428-02 | Rite | 100 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 49483-0373-01 | TIME | 100 tablets | — | — | FDA listed | — |
| DoloDent Toothache For adults 65 mg/1; 500 mg 55758-0435-24 | Pharmadel | 24 tablets | — | — | FDA listed | — |
| Tension Headache Aspirin Free 500 mg/1; 65 mg 59779-0824-06 | CVS | 200 tablets | — | — | FDA listed | — |
| DRX CHOICE Tension Headache 500 mg/1; 65 mg 68163-0506-15 | Raritan | 15 tablets | — | — | FDA listed | — |
| Sed-Max 500 mg/1; 65 mg 69197-0029-20 | Command | 20 tablets | — | — | FDA listed | — |
| Cafizetamol Forte 500 mg/1; 65 mg 69729-0147-40 | OPMX | 40 tablets | — | — | FDA listed | — |
| Migrafein FORTE 500 mg/1; 65 mg 69729-0148-40 | OPMX | 40 tablets | — | — | FDA listed | — |
| Neo-Lubrina Fuerte 500 mg/1; 65 mg 69729-0149-24 | OPMX | 12 tablets | — | — | FDA listed | — |
| Mejoral 500 mg/1; 65 mg 69729-0154-24 | OPMX | 12 tablets | — | — | FDA listed | — |
| KORTRIBION Pain Reliever 500 mg/1; 65 mg 69729-0793-24 | OPMX | 12 tablets | — | — | FDA listed | — |
| Doloneuro-Tropas 500 mg/1; 65 mgthis 69729-0795-80 | OPMX | 4 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 69732-0007-01 | Hi-Tech | 100 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 72090-0004-02 | Pioneer | 200 tablets | — | — | FDA listed | — |
| Tension Headache Pain Relieving Aid 500 mg/1; 65 mg 79903-0373-01 | WAL-MART | 100 tablets | — | — | FDA listed | — |
| NOTTS - Tension Headache 500 mg/1; 65 mg 82706-0010-01 | VIVUNT | 24 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 84324-0002-01 | NUVICARE | 100 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 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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
red
ShapeOval
Imprint5431
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.
- FDA label on DailyMed · label index refreshed Oct 8, 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII 2LRS185U6K
D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
-
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
-
UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
-
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 RDH86HJV5Z
Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
-
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 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
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.
13 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescolloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #1, FD&C yellow #6, magnesium stearate, microcrystaline cellulose, polyethylene glycol, pregelatinized starch, polyvinyl pyrolidone, stearic acid, tale, titanium dioxide
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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
LabelerOPMX LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code69729
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio87 products on file
More NDCs from OPMX LLC labeler code 69729
- TESALON Tesaperlas Severe Cold Max Relief Dextromethorphan HBr, Guaifenesin 20 mg; 400 mg Capsule, Liquid Filled NDC 69729-788-20
- Pentrexcilina Children TOTAL RELIEF Multi-Symptom Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin USP, Phenylephrine Hydrochloride 5 mg/10mL; 250 mg/10mL; 13.33 mg/10mL; 200 mg/10mL Syrup NDC 69729-789-06
- Pentrexcilina Adult TOTAL RELIEF Multi-Symptom Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin USP, Phenylephrine Hydrochloride 10 mg/20mL; 500 mg/20mL; 26.66 mg/20mL; 400 mg/20mL Syrup NDC 69729-790-06
- RIOPAN Esomeprazole 20 mg Capsule, Delayed Release NDC 69729-791-14
- KORTRIBION Pain Reliever Acetaminophen, Caffeine 500 mg; 65 mg Tablet, Film Coated NDC 69729-793-24
- DIPROSPAN Hydrocortisone 10 mg/g Cream NDC 69729-794-02
- ATAMEL Forte Acetaminophen 650 mg Tablet, Coated NDC 69729-800-24
- Crocin MAX Acetaminophen 650 mg Capsule, Gelatin Coated NDC 69729-801-24
- AGRIFEN Acetaminophen, Dextomethorphan Hydrobromide, Phenylephrine Hydrochloride 325 mg; 5 mg; 10 mg Capsule, Liquid Filled NDC 69729-802-10
- Lombrix PYRANTEL PAMOATE 180 mg Tablet NDC 69729-807-10
- Coldtac Severe Cold Max Relief Acetaminohpen, Dextromethorphan Hydrobromide 325 mg; 10 mg Capsule, Liquid Filled NDC 69729-808-10
- tabcin ACTIVE Acetaminophen, Dextromethorphan Hydrobromide 10 mg; 325 mg Capsule, Liquid Filled NDC 69729-809-10
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 8, 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Do Not Use
📄 Ask a Doctor Before Use If
📄 Ask a Doctor or Pharmacist Before Use If
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Other Information
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses temporarily relief minor aches and pains due to: headache muscular aches
⏱️ Dosage and Administration ▾
Directions do not exceed recommended dosage. adults and children 12 years and over: take 2 tablets every 6 hours; do not take more than 6 tablets in 24 hours children under 12 years: ask a doctor
⚠️ Warnings ▾
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 with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing metications, foods, or beverages while taking this product because too much cafeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
Do not use with anyother drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. Ask a doctor before use if you have liver disease Ask a doctor or pharmacist if you are taking the blood thinning drug warfarin Stop use and ask a doctor if any new symptoms appear symptoms do not get better or worsen painful area is red or swollen 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, 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 (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.
🧪 Active Ingredient ▾
Drug Facts Active Ingredient (in each tablet) Acetaminophen 500mg Caffeine 65 mg
🧪 Inactive Ingredients ▾
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #1, FD&C yellow #6, magnesium stearate, microcrystaline cellulose, polyethylene glycol, pregelatinized starch, polyvinyl pyrolidone, stearic acid, tale, titanium dioxide
🎯 Purpose ▾
Purpose Pain reliever Pain reliever aid
📄 Do Not Use ▾
Do not use with anyother drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have liver disease
📄 Ask a Doctor or Pharmacist Before Use If ▾
Ask a doctor or pharmacist if you are taking the blood thinning drug warfarin
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if any new symptoms appear symptoms do not get better or worsen painful area is red or swollen 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 ▾
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 (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.
📄 Other Information ▾
Other information store at controlled room temperatur 20° -25°C (68° -77°F) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
📄 Questions or Comments ▾
Questions or coments? Call for free 619-600-5632 Monday through Friday 9AM -5PM EST PLEASE REFER TO LEAFLET FOR INSTRUCTION IN SPANISH. CONSULTE EL FOLLETO PARA LAS INTRUCCIONES EN ESPAÑOL.
📄 Package Label / Principal Display Panel ▾
NDC 69729-795-80 DOLONEURO-TROPAS NUEVAFORMULA NEW FORMULA Treat Pain or Inframation caused by conditions such as: Alivio temporal de dolores leves y malestares debidos a: Reumatismo Artritis Inflamacion Dolor Rheumatism Arthritis Inflamation Pain 20 Sachets of 4 Caplets Analgesico/Pain Reliever PDP1 sachet
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 DOLONEURO-TROPAS (this brand).
Top reported reactions
Age at onset
Reporter sex
Female · 100%
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) | ✓ 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 12 tablets (69729-0795-24). 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?
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.
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.