Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Cough Suppressant Adult Dextromethorphan Hydrobromide 15 mg Capsule, Liquid Filled, 20-count — NDC 0536-1480-34 (Billing 00536-1480-34)
by Rugby Laboratories · 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
This is a package of 20 capsules of Cough Suppressant Adult Dextromethorphan Hydrobromide 15 mg Capsule, Liquid Filled from Rugby Laboratories, marketed since May 2026 and currently FDA-listed. It is this product's only package size.
NDC 00536-1480-34
🏷️ FDA NDC (as labeled)
0536-1480-34
billing pads the labeler segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 0536-1480-34 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0536 labeler · 1480 product · 34 package
- Package marketed since
- May 8, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0305361480349
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
0536-1480-34
Product NDC
0536-1480
11-digit billing NDC
00536148034
RxCUI
1090487
UNII
9D2RTI9KYH
UPC
0305361480349
Application #
M012
SPL Set ID
47b713bd-4c1e-f44a-e063-6294a90a63d3
Established class (EPC)
Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action
Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-05-08
Route
ORAL
Dosage form
CAPSULE, LIQUID FILLED
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Quick answers
- RxCUI (RxNorm): 1090487
Why two NDCs?
The FDA registers this code as 0536-1480-34 — a 4-4-2 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 labeler segment → 00536-1480-34. 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
RxNorm drug class
This medicine belongs to the Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.
Pharmacologic class
Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC)
Other antidepressants, Opium alkaloids and derivatives
How it works
Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists
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
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- It's a cough suppressant. It temporarily relieves cough from minor throat and bronchial irritation, like with a cold or inhaled irritants. Some products also help you sleep by calm...
- It depends on the product. Extended-release suspensions like Delsym are labeled for every 12 hours, while Giltuss Honey DM Cough is every 6 to 8 hours with a 4-dose daily limit. Ch...
- Be careful. Don't use it if you take a prescription MAOI, or within 2 weeks of stopping one. If you're not sure whether your medicine is an MAOI, ask me or your doctor before takin...
- Nighttime products can cause marked drowsiness, and children may become excitable. Avoid alcohol and be careful driving.
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 Dextromethorphan Hydrobromide?
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 mL | 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 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 |
|---|---|---|---|---|
| 00536-1480-34 You're viewing this Main listing | 20 CAPSULE, LIQUID FILLED in 1 BOTTLE | 2026-05-08 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dextromethorphan HBr 15 mg Liquid Gels 00536-1334-34 | RUGBY | 20 capsules | $0.122 | — | Availability likely | — |
| QUALITY CHOICE Long Acting Cough Softgel 15 mg 83324-0303-20 | Chain | 20 capsules | $0.122 | — | Availability likely | — |
| Robitussin Long-Acting Coughgels 15 mg 00031-8743-20 | Haleon | 20 capsules | — | — | FDA listed | — |
| Robitussin Direct Cough 15 mg 00031-9302-01 | Haleon | 18 capsules | — | — | FDA listed | — |
| Cough Relief 15 mg 00363-8990-20 | WALGREEN | 20 capsules | — | — | FDA listed | — |
| Cough Suppressant Adult 15 mgthis 00536-1480-34 | Rugby | 20 capsules | — | — | FDA listed | — |
| Dextromethorphan Hydrobromide 15 mg 35916-0461-01 | Softgel | 20 capsules | — | — | FDA listed | — |
| Long Acting Cough Softgels 15 mg 51316-0778-23 | CVS | 20 capsules | — | — | FDA listed | — |
| CVS Health COUGH SUPPRESSANT SOFTGEL 15 mg 51316-0877-23 | CVS | 20 capsules | — | — | FDA listed | — |
| Dextromethorphan HBr 15 mg 53345-0011-01 | Humanwell | 12000 capsules | — | — | FDA listed | — |
| Dextromethorphan HBr 15 mg 53345-0028-01 | Humanwell | 12000 capsules | — | — | FDA listed | — |
| Right Remedies Adult Long Lasting Cough Relief Softgel 15 mg 70692-0778-06 | Strive | 60 capsules | — | — | FDA listed | — |
| Gencare Long-Acting Cough Relief 15 mg 72090-0063-01 | PIONEER | 120 capsules | — | — | FDA listed | — |
| Dextromethorphan Hbr 15 Mg 73629-0005-10 | AMZ789 | 100 capsules | — | — | FDA listed | — |
| Cough Relief 15 mg 80513-0311-06 | Advanced | 60 capsules | — | — | FDA listed | — |
| ValuMeds Cough Relief, Dextromethorphan Hbr 15 mg 82725-1010-01 | Cabinet | 120 capsules | — | — | FDA listed | — |
| Goodmeds Non-Drowsy Cough Relief 15 mg 82725-4010-01 | Cabinet | 120 capsules | — | — | FDA listed | — |
| Goodmeds Cough Relief Dextromethorphan HBr 15 mg 82725-4110-01 | Cabinet | 120 capsules | — | — | FDA listed | — |
| Adult Long Lasting Cough Relief 15 mg 83059-0027-01 | Shield | 15 capsules | — | — | Discontinued | — |
| Adult Long Lasting Cough Relief 15 mg 83059-0110-08 | Shield | 15 capsules | — | — | Discontinued | — |
| Nuvicare Long-Acting Cough Relief 15 mg 84324-0037-01 | NUVICARE | 60 capsules | — | — | FDA listed | — |
| QUALITY CHOICE Adult Long-Acting Cough Softgel 15 mg 83324-0346-20 | Chain | 20 capsules | — | — | 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
May 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
ImprintT
Size14 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.
🧪 Avoiding an ingredient? See Dextromethorphan 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
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 WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
-
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
-
UNII 8D4SNN7V92
Propyl gallate is a synthetic antioxidant derived from gallic acid. It prevents oils and fats in the medicine from oxidizing and spoiling, helping the product stay stable and effective during storage.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII 6O92ICV9RU
A waxy substance derived from sorbitol that helps mix oil and water together in medicines. It's used as an emulsifier to keep ingredients evenly blended and stable.
-
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
11 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesFD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propyl gallate, propylene glycol, purified water, Polyvinylpyrrolidone, sorbitol sorbitan solution
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
LabelerRugby Laboratories
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedMay 2026
Product typeHuman Otc Drug
Portfolio149 products on file
More NDCs from Rugby Laboratories labeler code 00536
- Rugby Benzoyl Peroxide Acne Medication 25 mg/g Gel NDC 0536-1466-25
- Rugby Benzoyl Peroxide Acne Medication 50 mg/g Gel NDC 0536-1467-25
- Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g Lotion NDC 0536-1474-42
- Lubricant Eye Carboxymethylcellulose Sodium 5 mg/mL Solution/ Drops NDC 0536-1476-92
- Rugby Pain Relieving Analgesic Menthol, Unspecified Form and Methyl Salicylate 12.5 mg/g; 150 mg/g Cream NDC 0536-1477-45
- Olopatadine HCl olopatadine hydrochloride 7 mg/mL Solution/ Drops NDC 0536-1478-23
- Rugby Antifungal tolnaftate aerosol, powder 10 mg/g Aerosol, Spray NDC 0536-1481-01
- Senna 8.8 mg/5mL Solution NDC 0536-1483-59
- Rugby Mucus Relief ER guaifenesin 600 mg Tablet, Multilayer, Extended Release NDC 0536-1489-20
- Rugby Allergy Relief D fexofenadine hydrochloride, pseudoephedrine hydrochloride 60 mg; 120 mg Tablet, Film Coated, Extended Release NDC 0536-1491-07
- Sebex Antidandruff, anti-seborrheic dermatitis, anti-psoriasis Salicylic Acid, Sulfur 20 mg/1000mL; 20 mg/1000mL Shampoo NDC 0536-1962-97
- Rugby Anti-Dandruff Selenium Sulfide 10 mg/mL Shampoo NDC 0536-1995-53
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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
⏱️ Dosage and Administration ▾
Directions • do not take more than 8 softgels in any 24-hour period • this adult product is not intended for use in children under 12 years of age adults and children 12 years and older take 2 softgels every 6 to 8 hours, as needed children under 12 years do not use
⚠️ Warnings ▾
Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAΟΙ drug. If you do not know if your prescription drug contains an MAΟΙ, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • a cough that occurs with too much phlegm (mucus) • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
📦 Storage and Handling ▾
Other information • store below 25°C (77°F) • avoid excessive heat above 40°C(104°F) • protect from light
🧪 Active Ingredient ▾
Active ingredient (in each softgel) Dextromethorphan HBr, USP 15 mg
🧪 Inactive Ingredients ▾
Inactive ingredients FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propyl gallate, propylene glycol, purified water, Polyvinylpyrrolidone, sorbitol sorbitan solution
🎯 Purpose ▾
Purpose Cough Suppressant
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
📄 Questions or Comments ▾
Questions or comments? Call 1-888-577-8033 Monday-Friday 8AM-4PM EST
📄 Package Label / Principal Display Panel ▾
Packaging Cough Suppressant
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 Cough Suppressant Adult (this brand).
Top reported reactions
Reporter sex
Male · 51%
Female · 49%
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) | ✓ 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 Rugby Laboratories. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rugby Laboratories 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.