NDC 70621-101-01 - AMELUZ
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
- 70621-101
- Requested NDC
- 70621-101-01
- Package NDCs from labels
- 70621-101-01, 70621-101-10, 70621-101-03, 70621-101-30, 70621-101-20
- Manufacturer
- Biofrontera Inc. | Glaropharm AG
- Effective date
- 2026-10-13
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| AMELUZ - Biofrontera Inc. | Glaropharm AG | Biofrontera Inc. | Glaropharm AG | 2026-10-13 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70621-101-01 | AMELUZ | 2 g in 1 TUBE | GEL | 2 | 31 | |
| 70621-101-03 | AMELUZ | 2 g in 1 TUBE | GEL | 2 | 31 | |
| 70621-101-10 | AMELUZ | 1 in 1 PACKAGE | GEL | 1 | 31 | |
| 70621-101-20 | AMELUZ | 10 in 1 PACKAGE | GEL | 10 | 31 | |
| 70621-101-30 | AMELUZ | 1 in 1 PACKAGE | GEL | 1 | 31 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70621-101-01 | GM - Gram | 70621-101 | da1ef119-6658-4911-bd73-e37b1c7be8f3 | 1 | 2016-11-08 |
| 70621-101-10 | GM - Gram | 70621-101 | 9f3c1b6b-db39-4108-aef1-8f7eb907844b | 1 | 2019-05-02 |
| 70621-101-20 | GM - Gram | 70621-101 | d4402acc-5bb5-400e-9439-d3f05a9fea6f | 1 | 2022-04-06 |
| 70621-101-30 | GM - Gram | 70621-101 | 76350f04-0fd0-4a15-9c45-64d5b8b85a75 | 1 | 2019-05-02 |
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 |
|---|---|---|---|---|---|---|
| Medi-First Isopropyl Alcohol 70% | ISOPROPYL ALCOHOL | Unifirst First Aid Corporation | dbeac2f5-b897-5e71-e053-2995a90a7549 | 2024-01-17 | Warnings | ND2M416302 |
| American Safety First Aid Antispetic | ISOPROPYL ALCOHOL | Orazen Inc | ea302ba4-a63d-e713-e053-2995a90a3fc4 | 2024-01-15 | Warnings | ND2M416302 |
| Alcohol Prep Pad | ALCOHOL PREP PAD | BioMed Resource Inc. | 03be8a96-c163-0e22-e054-00144ff8d46c | 2024-01-10 | Warnings | ND2M416302 |
| Meijer 70 Isopropyl Alcohol Wipes First Aid Antiseptic | ISOPROPYL ALCOHOL | Meijer, Inc | 2046162f-cb70-416c-ae37-14999883a807 | 2024-01-09 | Warnings | ND2M416302 |
| F02 ANGR-FLX | ADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLE | Apex Energetics Inc. | bc7c2bf3-8b0d-766f-e053-2a95a90ad34c | 2024-01-08 | Warnings | 059QF0KO0R |
| F09 LTGO | ADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALIS | Apex Energetics Inc. | bd1e652f-b3a4-c5bd-e053-2995a90ae03f | 2024-01-08 | Warnings | 059QF0KO0R |
| N04 RAD-TOX | ALOE SOCOTRINA, BONE MARROW SUIS, BOS TAURUS PLACENTA, BOS TAURUS SKIN, DNA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, FERRUM METALLICUM, FUCUS VESICULOSUS, IODIUM, KALI PHOSPHORICUM, PHOSPHORUS, RIBES NIGRUM FLOWER BUD, SOY LECITHIN, VITAMIN A ACETATE, VITAMIN E ACETATE | Apex Energetics Inc. | bd08de24-ee4d-12bc-e053-2995a90a87b8 | 2024-01-08 | Warnings | 1DI56QDM62 |
| Fendall 2000 Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | b56ef662-fec2-4d94-e053-2995a90aba2b | 2024-01-06 | Warnings | 059QF0KO0R |
| Alcohol Prep | ISOPROPYL ALCOHOL | Topco Associates | 65270825-48b1-49e7-a14e-f73df9beb9dd | 2023-12-27 | Warnings | ND2M416302 |
| Ear Drops for Swimmers | ISOPROPYL ALCOHOL | Pharma Nobis, LLC | e42fd693-24ab-0fc0-e053-2995a90ab954 | 2023-12-26 | Warnings | ND2M416302 |
| Isopropyl Alcohol 70 Percent With Wintergreen Oil | ISOPROPYL ALCOHOL | Pharma Nobis, LLC | e42f6c6d-c4e1-02c6-e053-2995a90a3ace | 2023-12-26 | Warnings | ND2M416302 |
| Leader Eye Wash | PURIFIED WATER | Cardinal Health | 8d3ad11f-1945-f838-e053-2995a90a7aa5 | 2023-12-23 | Warnings | 059QF0KO0R |
| LEADER Ear Drops for Swimmers | LEADER EAR DROPS FOR SWIMMERS | Cardinal Health, 110 dba Leader | 874857eb-2a9d-6ef7-e053-2995a90af156 | 2023-12-22 | Warnings | ND2M416302 |
| Isopropyl Rubbing Alcohol 70 Percent | ISOPROPYL ALCOHOL | Pharma Nobis, LLC | e42f727c-beb0-fe9d-e053-2995a90aafea | 2023-12-22 | Warnings | ND2M416302 |
| Isopropyl Alcohol 91 Percent | ISOPROPYL ALCOHOL | Pharma Nobis, LLC | e42f6c6d-c4e0-02c6-e053-2995a90a3ace | 2023-12-22 | Warnings | ND2M416302 |
| NUMSTAT Antiseptic and Pain Relieving Prep Pad | ALCOHOL, MENTHOL, AND BENZOCAINE PREP PAD | Spectra Medical Devices, LLC | 07d20040-9dd9-0aba-e063-6294a90ab7cf | 2023-12-20 | Warnings | ND2M416302 |
| Health Mart Isopropyl Alcohol 91 Percent | ISOPROPYL ALCOHOL | Strategic Sourcing Services LLC | fbd2aa69-b1c7-4a28-9642-a436ae09faaf | 2023-12-20 | Warnings | ND2M416302 |
| Quality Choice Instant Ear Dry | ISOPROPYL ALCOHOL | Chain Drug Manufacturing Association | 9d3c681b-a941-6ddb-e053-2a95a90ad3bf | 2023-12-20 | Warnings | ND2M416302 |
| Premiere Value Ear Drops for Swimmers | ISOPROPYL ALCOHOL | Pharmacy Value Alliance; LLC | 9d606fe6-ae57-724f-e053-2a95a90abffe | 2023-12-20 | Warnings | ND2M416302 |
| CVS Ear Drops for Swimmers | ISOPROPYL ALCOHOL | CVS Pharmacy | cc4614ee-5d6e-4a07-9826-aff12cc35abd | 2023-12-20 | Warnings | ND2M416302 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.