NDC 31722-676-35 - Roflumilast
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 31722-676
- Requested NDC
- 31722-676-35
- Package NDCs from labels
- 31722-676-31, 31722-676-32, 31722-676-35, 31722-676-36
- Manufacturer
- Camber Pharmaceuticals, Inc. | Hetero Labs Limited Unit III
- Effective date
- 2023-04-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Roflumilast - Camber Pharmaceuticals, Inc. | Hetero Labs Limited Unit III | Camber Pharmaceuticals, Inc. | Hetero Labs Limited Unit III | 2023-04-28 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 31722-676-31 | Roflumilast | 10 in 1 BLISTER PACK | TABLET | 10 | 2 | |
| 31722-676-32 | Roflumilast | 2 in 1 CARTON | TABLET | 2 | 2 | |
| 31722-676-35 | Roflumilast | 28 in 1 BLISTER PACK | TABLET | 28 | 2 | |
| 31722-676-36 | Roflumilast | 1 in 1 CARTON | TABLET | 1 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 31722-676-31 | EA - Each | 31722-676 | 9eed0415-5967-49fa-9c2e-a7e02956044b | 1 | 2023-05-05 |
| 31722-676-32 | EA - Each | 31722-676 | bbf33867-e182-4032-bc82-c658e3406305 | 1 | 2023-05-05 |
| 31722-676-35 | EA - Each | 31722-676 | 26dcc3c3-f74a-4057-94b0-775b636b1eae | 1 | 2023-05-05 |
| 31722-676-36 | EA - Each | 31722-676 | 92a5f15d-a359-4dbe-aeaf-5ce1716ee794 | 1 | 2023-05-05 |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Muscle Ice | PHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS) | Peaceful Mountain, Inc. | 03b6e2a9-f335-4ae2-9011-80bd019afb72 | 2026-07-30 | Warnings | ETJ7Z6XBU4 |
| Headache | MELILOTUS OFFICINALIS, SPIGELIA ANTHELMIA, ALLIUM CEPA, BELLADONNA, BRYONIA (ALBA), CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, SANGUINARIA CANADENSIS, SILICEA, TARENTULA CUBENSIS | BioActive Nutritionals, Inc. | 918bc478-78a2-41e1-b123-f5350cf8f43a | 2026-07-30 | Warnings | ETJ7Z6XBU4 |
| Prid | ICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFUR | Hyland's Inc. | 49689eeb-7790-07f1-e063-6294a90a2df2 | 2026-07-16 | Warnings | ETJ7Z6XBU4 |
| Leg Cramps PM | OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFUR | Hyland's Inc. | b0574a7e-88fa-417e-b6d5-60ced59eba47 | 2026-07-15 | Warnings | ETJ7Z6XBU4 |
| Roflumilast | ROFLUMILAST | Jubilant Cadista Pharmaceuticals Inc. | aaa81c1b-f63d-4e61-8bfa-9d42d92043c7 | 2026-07-14 | Warnings, Adverse reactions | 2001319 1091839 0P6C6ZOP5U |
| Jacksons Cell Salts SILICA 12X 12 | SILICEA | Zettl Health Inc. | 5647dafc-1fff-6a25-e063-6294a90a8b4f | 2026-07-10 | ETJ7Z6XBU4 | |
| ZORYVE | ROFLUMILAST | Arcutis Biotherapeutics, Inc. | ec1bb0d1-f38a-4080-831a-68791d1d1fdb | 2026-07-02 | Adverse reactions | 0P6C6ZOP5U |
| The Cell Salt Co. Daily Blend 12 in 1 | CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA | The Cell Salt Company LLC | 55826f59-acf4-7370-e063-6394a90afed7 | 2026-07-01 | Warnings | ETJ7Z6XBU4 |
| Bambusa Stannum | BAMBUSA STANNUM | Uriel Pharmacy Inc. | a0d4d0ac-e2d2-4381-8f93-e41719521859 | 2026-06-30 | Warnings | ETJ7Z6XBU4 |
| roflumilast | ROFLUMILAST | AvKARE | 55009549-3f0c-1f58-e063-6294a90a6c03 | 2026-06-24 | Warnings, Adverse reactions | 2001319 1091839 0P6C6ZOP5U |
| ZORYVE | ROFLUMILAST | Arcutis Biotherapeutics, Inc. | f9e0b4a9-a227-4947-b00c-41fb18d16589 | 2026-06-22 | Warnings, Adverse reactions | 0P6C6ZOP5U |
| H-Scars Formula | CALENDULA OFFICINALLIS, SILICEA | Healing Natural Oils LLC | 8433ff00-d815-45e0-b0ec-1448668dd8f8 | 2026-06-16 | Warnings | ETJ7Z6XBU4 |
| E-Z-GAS II | ANTACID/ANTIFLATULENT | E-Z-EM, INC. | 4e12e1cb-b033-076d-e054-00144ff8d46c | 2026-06-15 | Warnings | ETJ7Z6XBU4 |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 544b66c4-49df-556f-e063-6394a90af3ed | 2026-06-15 | Warnings | ETJ7Z6XBU4 |
| BM Tooth Remineralization | CALC PHOS, CALC FLUOR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 543bc298-ec32-38e9-e063-6394a90aac15 | 2026-06-14 | Warnings | ETJ7Z6XBU4 |
| Nail Fungus Control Extra Strength | CALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUM | Forces of Nature | d02b88a6-1999-4dcd-91b5-fad88a664fcb | 2026-06-14 | Warnings | ETJ7Z6XBU4 |
| Nerve Pain | ARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUM | Forces of Nature | a9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb7 | 2026-06-14 | Warnings | ETJ7Z6XBU4 |
| Scar Control | CALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDE | Forces of Nature | 595c3423-6b52-48fc-8a95-00b53c1ecc7b | 2026-06-14 | Warnings | ETJ7Z6XBU4 |
| BM BM186 DROPS | ARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 54243745-bd67-19c1-e063-6394a90a4b72 | 2026-06-13 | Warnings | ETJ7Z6XBU4 |
| BM BM186 DROPS | ARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICA | BM Private Limited | 540d8fbe-3bdb-1b54-e063-6394a90a114d | 2026-06-12 | Warnings | ETJ7Z6XBU4 |