Inactive ingredients by manufacturer

Naldemedine inactive ingredients by manufacturer

Wondering whether your Naldemedine has lactose, gluten, soy, a dye or gelatin in it? The medicine is the same, but the fillers, coatings and colors differ from one company to the next. This page shows what each Naldemedine product's FDA label lists, so you can find a version that leaves out what you avoid and ask your pharmacist for it by its NDC.

We have read the FDA label of 1 of the 1 current Naldemedine product on the market today, from 1 company listing it with the FDA, and lined them up side by side.

Dr. Brian Staiger, PharmD, BCPS
Curated and coded by Dr. Brian Staiger, PharmD, BCPS, clinical pharmacist. The ingredient groups this page checks for (what counts as a gluten source, a synthetic dye, soy and so on) are his classification; the lists themselves are the manufacturers' own FDA labels. Updated October 6, 2026. Rebuilt daily from the FDA directory; labels re-read when the FDA publishes a new version.

Ask about your bottle

Is there something in your Naldemedine? Ask in plain words.

Name the company, strength or the NDC on your bottle and the ingredient you avoid. The answer comes only from the FDA labels on this page.

Answers are drawn from the FDA label data on this page and checked against it. They are not medical advice: confirm with your pharmacist before relying on them.

The short answer

Which Naldemedine products list lactose, a gluten source, soy, dyes or gelatin?

  1. LactoseNo checked product

    No checked Naldemedine product lists lactose.

  2. Wheat or gluten sourceNo checked product

    No checked Naldemedine product lists a wheat or gluten source.

  3. SoyNo checked product

    No checked Naldemedine product lists soy.

  4. Synthetic dyesNo checked product

    No checked Naldemedine product lists synthetic dyes.

  5. GelatinNo checked product

    No checked Naldemedine product lists gelatin.

Also listed by some products: Sorbitol or mannitol 1 of 1

Find a version without it

Every current Naldemedine product and what its label lists

Hide products that list:

Naldemedine 0.2 mg tablet 1 company Sorbitol or mannitol 1
CompanyListsInactive ingredients on the label
BioDelivery SciencesNDC 59385-0041-07 Sorbitol or mannitol
Show 6 ingredients

Croscarmellose Sodium, Ferric Oxide Yellow, Hypromellose, Unspecified, Magnesium Stearate, Mannitol, Talc

A product with none of these listed is not certified to be without them: the label says what the manufacturer declared, and the source of a starch or a flavor is often not stated. The companies are the FDA's labelers, which include repackagers and distributors selling another company's product under their own label. The NDC opens the product's own page, with the full label and its inactive-ingredient notes.

Naldemedine and sorbitol or mannitol

Sorbitol or mannitol: sugar alcohols that can cause bloating or diarrhea in larger amounts. Every checked Naldemedine product (1) lists sorbitol or mannitol.

Show which Naldemedine products list sorbitol or mannitol and which do not, by product and company

Lists sorbitol or mannitol

At the pharmacy counter

How to use this at the pharmacy counter

  1. Pick the company whose list suits you and copy the NDC from the table. Many pharmacies order from wholesalers that carry several companies' versions and can request a particular one if you ask before the prescription is filled; some buy from one contracted source only, and a few insurance plans cover only certain NDCs, so ask the pharmacist to check.
  2. Treat "does not list" as exactly that. The label is what the manufacturer declared; a flavor or a starch may have an unstated source, and lines change. For celiac disease or a serious allergy, ask the manufacturer's medical information line for a written statement about the lot you have.
  3. Check the bottle each refill. A different company usually means a different shape, color and inactive-ingredient list; the pharmacist can tell you who made it, and the two-NDC comparison shows the difference line by line.
  4. If you need one company's version kept constant, ask your prescriber to write that company or the NDC on the prescription and tell the pharmacy you need it held. Rules vary by state and plan, so confirm with the pharmacist.
Ask Dr. Staiger which Naldemedine product suits you →

Common questions about Naldemedine inactive ingredients

Is Naldemedine gluten-free?
This page cannot certify any Naldemedine product gluten-free; it reports what each label declares. Of the 1 product checked, none lists a wheat, barley, rye or gluten ingredient, and none lists a starch without a stated source. If you have celiac disease, ask the manufacturer's medical information line for a written gluten statement for the lot you have.
Does Naldemedine contain lactose?
No checked Naldemedine product lists lactose on its label. The lactose in a tablet or capsule is a small amount, but people with a milk allergy or a strong intolerance often prefer a version that does not list it.
Does Naldemedine contain soy?
No checked Naldemedine product lists a soy ingredient (soybean oil or soy lecithin) on its label. Soy lecithin is the usual form and the amount is small, but people with a soy allergy often prefer a version that does not list it.
Is there a dye-free Naldemedine?
No checked Naldemedine product lists a synthetic dye (an FD&C or D&C colorant) on its label. Colorants often differ by strength within one company's line, so compare the lists above strength by strength.
Does Naldemedine contain gelatin?
No checked Naldemedine product lists gelatin on its label. Gelatin is usually bovine or porcine and the label rarely says which; for kosher, halal or vegetarian needs, ask the manufacturer.
Why do the inactive ingredients differ between manufacturers?
A generic must match the brand's active ingredient, strength, dose form and how it is absorbed; its fillers, binders, coatings and colorants are the manufacturer's own choice. That is why one Naldemedine product can list lactose and a dye while another from a different company lists neither.
Can my pharmacy give me a specific manufacturer's version?
Often, if you ask before the prescription is filled: many pharmacies order from wholesalers that carry several companies' versions and can request a particular one. Some pharmacies buy a generic from one contracted source only, and a few insurance plans cover only certain NDCs, so ask the pharmacist to check. Give them the NDC from this page; the company name alone is often enough.
How current is this list?
The products are the ones in the FDA's current NDC directory as of October 6, 2026. The list is rebuilt every day, the FDA directory is re-imported every week, and each inactive-ingredient list is the manufacturer's FDA label as our label sync last read it, re-read when the FDA publishes a new version. Formulations change, so check the label on your own bottle and ask your pharmacist if a refill looks different.

Sources: the products are the finished Naldemedine products in the FDA's current NDC directory (openFDA), as of October 6, 2026; each inactive-ingredient list is the manufacturer's FDA Structured Product Label via DailyMed, as our label sync last read it. The concern groups are HelloPharmacist's classification of the names the label declares. Educational information only, not medical advice; confirm with your pharmacist before relying on a list. ← Back to the Naldemedine guide