Inactive ingredients by manufacturer

Roflumilast inactive ingredients by manufacturer

Wondering whether your Roflumilast 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 Roflumilast 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 labels of 28 of the 33 current Roflumilast products on the market today, from 17 companies listing it with the FDA, and lined them up side by side. 5 are still being read and will appear on a later visit.

Ask about your bottle

Is there something in your Roflumilast? 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 Roflumilast products list lactose, a gluten source, soy, dyes or gelatin?

  1. LactoseDiffers by manufacturer

    22 of 28 checked products list lactose; 6 do not. See the products

    Does not list it Arcutis Biotherapeutics Camber
    Lists it Amici Ascend AstraZeneca Aurobindo AvKARE Bryant Ranch Prepack Golden State Medical Supply Jubilant Cadista Major Micro Novadoz Solco Healthcare Zydus Zydus Lifesciences
  2. Wheat or gluten sourceNo checked product

    No checked Roflumilast product lists a wheat or gluten source.

  3. SoyNo checked product

    No checked Roflumilast product lists soy.

  4. Synthetic dyesNo checked product

    No checked Roflumilast product lists synthetic dyes.

  5. GelatinNo checked product

    No checked Roflumilast product lists gelatin.

Also listed by some products: Corn 22 of 28 PEG or polysorbate 9 of 28 Sorbitol or mannitol 2 of 28

Find a version without it

Every current Roflumilast product and what its label lists

Hide products that list:

ProductListsInactive ingredients on the label
American Health Packaging 1 product
500 mcg tabletNDC 60687-0786-21 Still being read Not read yet
Amici Pharma Inc. 2 products
250 mcg tabletNDC 69292-0630-10 Lactose Corn-derived
Show 4 ingredients

FERRIC OXIDE YELLOW, LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, STARCH, CORN
500 mcg tabletNDC 69292-0631-30 Lactose Corn-derived
Show 3 ingredients

LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, STARCH, CORN
Arcutis Biotherapeutics, Inc. 4 products
3 mg/g inhalerNDC 80610-0430-60 None of these listed
Show 15 ingredients

BUTANE, CETEARETH-10 PHOSPHATE, CETEARYL PHOSPHATE, CETOSTEARYL ALCOHOL, DIETHYLENE GLYCOL MONOETHYL ETHER, HEXYLENE GLYCOL, HYDROCHLORIC ACID, ISOBUTANE, ISOPROPYL PALMITATE, METHYLPARABEN, PROPANE, PROPYLPARABEN, SODIUM HYDROXIDE, WATER, WHITE PETROLATUM
0.5 mg/g ointment or gel topical creamNDC 80610-0105-60 None of these listed
Show 12 ingredients

CETEARETH-10 PHOSPHATE, CETEARYL PHOSPHATE, CETOSTEARYL ALCOHOL, DIETHYLENE GLYCOL MONOETHYL ETHER, HEXYLENE GLYCOL, HYDROCHLORIC ACID, ISOPROPYL PALMITATE, METHYLPARABEN, PROPYLPARABEN, SODIUM HYDROXIDE, WATER, WHITE PETROLATUM
1.5 mg/g ointment or gel topical creamNDC 80610-0115-60 None of these listed
Show 12 ingredients

CETEARETH-10 PHOSPHATE, CETEARYL PHOSPHATE, CETOSTEARYL ALCOHOL, DIETHYLENE GLYCOL MONOETHYL ETHER, HEXYLENE GLYCOL, HYDROCHLORIC ACID, ISOPROPYL PALMITATE, METHYLPARABEN, PROPYLPARABEN, SODIUM HYDROXIDE, WATER, WHITE PETROLATUM
3 mg/g ointment or gel topical creamNDC 80610-0130-60 None of these listed
Show 12 ingredients

CETEARETH-10 PHOSPHATE, CETEARYL PHOSPHATE, CETOSTEARYL ALCOHOL, DIETHYLENE GLYCOL MONOETHYL ETHER, HEXYLENE GLYCOL, HYDROCHLORIC ACID, ISOPROPYL PALMITATE, METHYLPARABEN, PROPYLPARABEN, SODIUM HYDROXIDE, WATER, WHITE PETROLATUM
Ascend Laboratories, LLC 2 products
250 mcg tabletNDC 67877-0730-05 Lactose Corn-derived
Show 4 ingredients

HYPROMELLOSE 2910 (3 MPA.S), LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, STARCH, CORN
500 mcg tabletNDC 67877-0480-05 Lactose Corn-derived
Show 4 ingredients

HYPROMELLOSE 2910 (3 MPA.S), LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, STARCH, CORN
AstraZeneca Pharmaceuticals LP 2 products
250 mcg tabletNDC 00310-0088-28 Lactose Corn-derived
Show 4 ingredients

lactose monohydrate, magnesium stearate, POVIDONE, UNSPECIFIED, starch, corn
500 mcg tabletNDC 00310-0095-30 Lactose Corn-derived
Show 4 ingredients

lactose monohydrate, magnesium stearate, POVIDONE, UNSPECIFIED, starch, corn
Aurobindo Pharma Limited 2 products
250 mcg tabletNDC 59651-0801-20 Lactose Corn-derived Polyethylene glycol or polysorbate
Show 5 ingredients

HYPROMELLOSE 2910 (5 MPA.S), LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, POLOXAMER 188, STARCH, CORN
500 mcg tabletNDC 59651-0275-30 Lactose Corn-derived Polyethylene glycol or polysorbate
Show 5 ingredients

HYPROMELLOSE 2910 (5 MPA.S), LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, POLOXAMER 188, STARCH, CORN
AvKARE 2 products
250 mcg tabletNDC 73190-0086-28 Still being read Not read yet
500 mcg tabletNDC 73190-0087-30 Lactose Corn-derived
Show 4 ingredients

HYDROXYPROPYL CELLULOSE (110000 WAMW), LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, STARCH, CORN
Bryant Ranch Prepack 1 product
500 mcg tabletNDC 72162-2385-03 Lactose Corn-derived
Show 4 ingredients

HYDROXYPROPYL CELLULOSE (1600000 WAMW), LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, STARCH, CORN
Camber Pharmaceuticals, Inc. 2 products
250 mcg tabletNDC 31722-0676-32 Sorbitol or mannitol
Show 5 ingredients

MAGNESIUM STEARATE, MANNITOL, METHYLENE CHLORIDE, MICROCRYSTALLINE CELLULOSE 102, SILICON DIOXIDE
500 mcg tabletNDC 31722-0623-30 Sorbitol or mannitol
Show 5 ingredients

MAGNESIUM STEARATE, MANNITOL, METHYLENE CHLORIDE, MICROCRYSTALLINE CELLULOSE 102, SILICON DIOXIDE
Golden State Medical Supply, Inc. 1 product
500 mcg tabletNDC 51407-0975-90 Lactose Corn-derived
Show 4 ingredients

HYPROMELLOSE 2910 (3 MPA.S), LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, STARCH, CORN
Jubilant Cadista Pharmaceuticals Inc. 2 products
250 mcg tabletNDC 59746-0801-70 Lactose Corn-derived
Show 3 ingredients

LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, STARCH, CORN
500 mcg tabletNDC 59746-0802-05 Lactose Corn-derived
Show 3 ingredients

LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, STARCH, CORN
Major Pharmaceuticals 3 products
250 mcg tabletNDC 00904-7493-71 Lactose Corn-derived Polyethylene glycol or polysorbate
Show 4 ingredients

LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, POLYSORBATE 80, STARCH, CORN
500 mcg tabletNDC 00904-7399-46 Lactose Corn-derived Polyethylene glycol or polysorbate
Show 4 ingredients

LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, POLYSORBATE 80, STARCH, CORN
500 mcg tabletNDC 00904-7483-03 Lactose Corn-derived Polyethylene glycol or polysorbate
Show 4 ingredients

LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, POLYSORBATE 80, STARCH, CORN
Micro Labs Limited 2 products
250 mcg tabletNDC 42571-0369-05 Lactose Corn-derived
Show 4 ingredients

HYDROXYPROPYL CELLULOSE (1600000 WAMW), LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, STARCH, CORN
500 mcg tabletNDC 42571-0259-05 Still being read Not read yet
Novadoz Pharmaceuticals LLC 2 products
250 mcg tabletNDC 72205-0201-24 Lactose Corn-derived Polyethylene glycol or polysorbate
Show 4 ingredients

LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, POLYSORBATE 80, STARCH, CORN
500 mcg tabletNDC 72205-0200-06 Lactose Corn-derived Polyethylene glycol or polysorbate
Show 4 ingredients

LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, POLYSORBATE 80, STARCH, CORN
Solco Healthcare US, LLC. 1 product
500 mcg tabletNDC 43547-0005-03 Lactose Corn-derived
Show 5 ingredients

COPOVIDONE K25-31, HYDROXYPROPYL CELLULOSE (1600000 WAMW), LACTOSE MONOHYDRATE, SODIUM STEARYL FUMARATE, STARCH, CORN
Zydus Pharmaceuticals USA Inc. 2 products
250 mcg tabletNDC 68382-0624-31 Still being read Not read yet
500 mcg tabletNDC 68382-0969-06 Lactose Corn-derived Polyethylene glycol or polysorbate
Show 7 ingredients

CELLULOSE, MICROCRYSTALLINE, HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED, LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, POLOXAMER 407, SILICON DIOXIDE, STARCH, CORN
Zydus Lifesciences Limited 2 products
250 mcg tabletNDC 70771-1673-03 Lactose Corn-derived Polyethylene glycol or polysorbate
Show 7 ingredients

CELLULOSE, MICROCRYSTALLINE, HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED, LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, POLOXAMER 407, SILICON DIOXIDE, STARCH, CORN
500 mcg tabletNDC 70771-1674-03 Still being read Not read yet

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.

Roflumilast without lactose

Lactose: milk sugar; a concern with lactose intolerance or a milk allergy. 22 of 28 checked products list lactose; 6 do not.

Does not list lactose

Lists lactose

Roflumilast without corn-derived ingredients

Corn-derived: corn starch, maize or corn syrup; a concern with corn allergy. 22 of 28 checked products list corn-derived ingredients; 6 do not.

Does not list corn-derived ingredients

Lists corn-derived ingredients

Roflumilast without polyethylene glycol or polysorbate

Polyethylene glycol or polysorbate: PEG, macrogol or polysorbate; a rare cause of allergic reactions. 9 of 28 checked products list polyethylene glycol or polysorbate; 19 do not.

Does not list polyethylene glycol or polysorbate

Lists polyethylene glycol or polysorbate

Roflumilast without sorbitol or mannitol

Sorbitol or mannitol: sugar alcohols that can cause bloating or diarrhea in larger amounts. 2 of 28 checked products list sorbitol or mannitol; 26 do not.

Does not list sorbitol or mannitol

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 Roflumilast product suits you →

Common questions about Roflumilast inactive ingredients

Is Roflumilast gluten-free?
This page cannot certify any Roflumilast product gluten-free; it reports what each label declares. Of the 28 products 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 Roflumilast contain lactose?
22 of 28 checked Roflumilast products list lactose; 6 do not: Arcutis Biotherapeutics (3 mg/g inhaler, 0.5 mg/g ointment or gel topical cream and 1.5 mg/g ointment or gel topical cream and 1 more) and Camber (250 mcg tablet and 500 mcg tablet). 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 Roflumilast contain soy?
No checked Roflumilast 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 Roflumilast?
No checked Roflumilast 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 Roflumilast contain gelatin?
No checked Roflumilast 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 Roflumilast 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 5, 2026, and each inactive-ingredient list is the manufacturer's FDA label as our label sync last read it. 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 Roflumilast products in the FDA's current NDC directory (openFDA), as of October 5, 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 Roflumilast guide