NDC 80425-0478-04 - BACLOFEN
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
- 80425-0478
- Requested NDC
- 80425-0478-04
- Package NDCs from labels
- 80425-0478-1, 80425-0478-3, 80425-0478-2, 80425-0478-4, 80425-0478-04
- Manufacturer
- Advanced Rx of Tennessee, LLC
- Effective date
- 2025-01-30
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| BACLOFEN - Advanced Rx of Tennessee, LLC | Advanced Rx of Tennessee, LLC | 2025-01-30 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0478-1 | BACLOFEN | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 80425-0478-2 | BACLOFEN | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 80425-0478-3 | BACLOFEN | 90 in 1 BOTTLE | TABLET | 90 | 1 | |
| 80425-0478-4 | BACLOFEN | 120 in 1 BOTTLE | TABLET | 120 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0478 | BACLOFEN TABLET [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 4 package rows | 20250201_2cf71f5f-6d46-7506-e063-6294a90a186f.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0478-1 | EA - Each | 80425-0478 | a3061446-53e2-452e-9c62-cd6d5a2cd80d | 1 | 2025-03-04 |
| 80425-0478-2 | EA - Each | 80425-0478 | 53d819e7-51e2-4bbd-980e-976cd5a42095 | 1 | 2025-03-04 |
| 80425-0478-3 | EA - Each | 80425-0478 | 28f6c518-c4cd-4f0e-8106-1030f3b3fabe | 1 | 2025-03-04 |
| 80425-0478-4 | EA - Each | 80425-0478 | d8ff5408-5a1e-480e-b317-c22da0aa0605 | 1 | 2025-03-04 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 |
| Baclofen | BACLOFEN | Cardinal Health 107, LLC | 3c87e116-871d-46b8-897b-fc27a17b988d | 2026-07-24 | Warnings, Adverse reactions | 430902 H789N3FKE8 |
| Baclofen | BACLOFEN | Preferred Pharmaceuticals Inc. | 3047613d-006b-4011-b5fe-098588f474aa | 2026-07-22 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| 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 |
| Baclofen | BACLOFEN | REMEDYREPACK INC. | 6274e70a-fb57-461b-b1bc-39d4ff916b2a | 2026-07-14 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Baclofen | BACLOFEN | Atlantic Biologicals Corp. | 50b3e7be-832b-313d-e063-6394a90a5ab4 | 2026-07-14 | Warnings, Adverse reactions | H789N3FKE8 |
| Jacksons Cell Salts SILICA 12X 12 | SILICEA | Zettl Health Inc. | 5647dafc-1fff-6a25-e063-6294a90a8b4f | 2026-07-10 | ETJ7Z6XBU4 | |
| 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 |
| Baclofen | BACLOFEN | REMEDYREPACK INC. | ebbfec9e-621c-4d04-8a1c-81d2eb9e9c74 | 2026-06-30 | Warnings, Adverse reactions | 197392 H789N3FKE8 |
| Bambusa Stannum | BAMBUSA STANNUM | Uriel Pharmacy Inc. | a0d4d0ac-e2d2-4381-8f93-e41719521859 | 2026-06-30 | Warnings | ETJ7Z6XBU4 |
| Baclofen | BACLOFEN | AvPAK | c21095a9-17b1-555a-e053-2a95a90a51fd | 2026-06-29 | Warnings, Adverse reactions | 430902 H789N3FKE8 |
| BACLOFEN | BACLOFEN | NuCare Pharmaceuticals, Inc. | 2517f71f-f452-1f56-e063-6394a90a6ef1 | 2026-06-25 | Warnings, Adverse reactions | ANDA214374 197391 H789N3FKE8 |
| 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 |