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dolene

Pharmaranks rates Dolene 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Dolene (Propoxyphene Hydrochloride) is a medication used to treat Pain.

Propoxyphene Hydrochloride · by Heritage Pharma

Generic of Darvon

72/100Limited · 1 source

Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →

Rated against independent regulatory sources·Last updated October 11, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass

Key facts

Form
Capsule
Strength
Propoxyphene Hydrochloride 65MG
Type
Prescription (Rx)
Brand or generic
Generic
May treat
pain
Manufacturer
Heritage Pharma
FDA application
ANDA080530
Availability
Discontinued (per FDA)

May treat (source: NIH RxClass)

Dosage forms

Capsule

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

Ask for the generic

Same active ingredient, far cheaper. Is there a generic? →

Request a 90-day supply

Bulk fills usually lower the per-dose price vs monthly refills.

Use copay cards

Manufacturer copay cards & patient-assistance programs — especially for brand drugs.

Compare alternatives

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Frequently asked questions

What does Dolene treat?
Dolene (Propoxyphene Hydrochloride) may be used to treat pain, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
How is Dolene rated?
pharmaranks gives Dolene a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
Is there a coupon or discount for Dolene?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Dolene. To pay less, Dolene is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Dolene?
Dolene is marketed by Heritage Pharma. You can see Heritage Pharma's full profile, rating, and other products on pharmaranks.
Is Dolene a brand-name or generic drug?
Dolene is a generic medication; its active ingredient is Propoxyphene Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
Is Dolene available over the counter?
No. Dolene is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Dolene come in?
Dolene is currently marketed as capsule, per the FDA's National Drug Code Directory.
Is Dolene FDA-registered?
Dolene is on record with the U.S. FDA under application number ANDA080530. You can verify this on its official FDA label.
Has Dolene been recalled by the FDA?
Dolene has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
Is Dolene safe?
There's no single safe-or-not verdict. pharmaranks gives Dolene a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.

Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

What people report to the FDA about PROPOXYPHENE HYDROCHLORIDE

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 5,659 reports naming PROPOXYPHENE HYDROCHLORIDE — the active ingredient in Dolene, and the FDA flagged 99% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • cardiac disorder1,300 reports
  • back pain447 reports
  • cardiovascular disorder314 reports
  • back injury245 reports
  • headache194 reports
  • nausea188 reports
  • arthralgia175 reports
  • abdominal pain153 reports

Read these as a signal, not a rate. A report does not mean PROPOXYPHENE HYDROCHLORIDE caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.

Source: openFDA drug/event (FAERS), retrieved September 26, 2026.

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