FDA.reportPublic FDA data

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 table
LabelManufacturerEffective dateType
AMELUZ - Biofrontera Inc. | Glaropharm AGBiofrontera Inc. | Glaropharm AG2026-10-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70621-101-01AMELUZ2 g in 1 TUBEGEL231
70621-101-03AMELUZ2 g in 1 TUBEGEL231
70621-101-10AMELUZ1 in 1 PACKAGEGEL131
70621-101-20AMELUZ10 in 1 PACKAGEGEL1031
70621-101-30AMELUZ1 in 1 PACKAGEGEL131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70621-101AMELUZ (AMINOLEVULINIC ACID HYDROCHLORIDE) GEL [BIOFRONTERA INC.]29Current NDC, Legacy NDC, 5 package rows20250418_650daa9f-aeec-49ce-95b9-5fa20b988afd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70621-101-01GM - Gram70621-101da1ef119-6658-4911-bd73-e37b1c7be8f312016-11-08
70621-101-10GM - Gram70621-1019f3c1b6b-db39-4108-aef1-8f7eb907844b12019-05-02
70621-101-20GM - Gram70621-101d4402acc-5bb5-400e-9439-d3f05a9fea6f12022-04-06
70621-101-30GM - Gram70621-10176350f04-0fd0-4a15-9c45-64d5b8b85a7512019-05-02

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.

Matched openFDA labels page 10 of 42 · 835 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IsopropylISOPROPYL ALCOHOLH E B25fea857-9ed8-49e7-b892-b24f639f83ca2026-02-24Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLH E B403e52e8-bac1-460a-81ef-bac5a7b5de102026-02-24Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLH E B28cd16f5-61c5-4943-9dd6-a9864fa358062026-02-24Warnings, Adverse reactionsExact identifier
unii: ND2M416302
50% Isopropyl AlcoholISOPROPYL ALCOHOLH E B0ed762dd-9432-45b4-9e75-c24fb28ff9562026-02-24Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Sunvine 70 Isopropyl Alcohol First Aid AntisepticISOPROPYL ALCOHOLMac Innovations, LLC8435ef45-5d2c-4bbb-b9e0-0b00c1ec8c762026-02-24WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLALCOVE BRANDS4bad1fee-b4fe-c518-e063-6294a90a03182026-02-24WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOL4 Visions LLC4b87d4cc-163e-1432-e063-6294a90af4832026-02-23WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions LLC4b88008f-fe78-4b7e-e063-6294a90ab9ae2026-02-23WarningsExact identifier
unii: ND2M416302
Universal Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC183efdc2-cf3e-4f06-b292-0cfd097418b32026-02-23WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLTarget Corporationb5455e53-2b86-48e7-a479-664f6601bab72026-02-18Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Travel Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCdd046146-fda7-438c-98ca-96ea1dd0ae0b2026-02-18WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLTarget Corporation4db7c9cb-021d-463a-9ff6-91ae42f0311d2026-02-18Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Companya631c976-cb9b-4099-8630-2a10c14bd3bd2026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLValu Merchandisers Companybe57aa83-f097-4ff8-81f8-13d731eea4e62026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Company81b5a92a-27a9-41d2-bc88-920833be66382026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLMedline Industries, LP26e10080-d389-4994-e054-00144ff8d46c2026-02-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMedline Industries, LPd980969d-694b-4c9e-a931-73beaceb51da2026-02-11WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLMedline Industries, LP2c85e3c0-2876-31c3-e054-00144ff88e882026-02-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMedline Industries, LP52a8b96e-dd4f-449e-b819-6f3ec5a27fb42026-02-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLTopco Associates LLCbe4f41bd-8a75-4fb6-8d28-67f6f853e6bd2026-02-11Warnings, Adverse reactionsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.