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 20 of 42 · 835 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadsISOPROPYL ALCOHOLHenry Schein, Inc.b9826baa-b976-14c6-e053-2995a90a7d092025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc9261c7f-9f8f-6476-e053-2a95a90a0e932025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLRugby Laboratoriesea28b27a-456e-4042-b769-f060727599332025-10-23WarningsExact identifier
unii: ND2M416302
School Health Sterile Alcohol Prep PadISOPROPYL ALCOHOLSchool Health Corporation718640e1-826b-4b65-a021-3f82cd4c983a2025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLHenry Schein, Inc.215fa8ac-c9b6-42b6-ae9d-a08d7ff0900f2025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health5459a0b4-65ca-455e-80b2-3fe1b24e01372025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa7d77afc-588d-47d7-be2f-686ff3d75da22025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC50b24287-4c91-43d2-9c2e-42d3c086b3b32025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC51b707c6-df09-441b-a3d1-3f0c1b0886cc2025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9c34be37-b6e2-4c08-96a5-d9bb0e738f2d2025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Swab SticksISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC91a9d6f7-d16c-46bf-8389-a6771e3ebfba2025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9d79480c-ceef-49f7-a830-171c2a2629392025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health 200, Inc.a1bccbf5-9cee-46c0-890c-02eb3577c1932025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol WipesISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC04c2ac54-1f44-a5d2-e063-6394a90a99cc2025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC2a160c89-c438-455d-910d-ac359d46786f2025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe917b371-3ca9-94f0-e053-2a95a90af8ad2025-10-23WarningsExact identifier
unii: ND2M416302
CareTouch Alcohol Prep PadISOPROPYL ALCOHOLFuture Diagnostics Llc91cfd7bf-9f42-49d5-b20d-281779d5272d2025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol WipeISOPROPYL ALCOHOLWalmart Inc.067c3983-d450-e86b-e063-6294a90ab7582025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC24337cc6-98fe-ca0b-e063-6394a90a8b7b2025-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa225426a-c4d5-459c-bc11-2b521e08e5102025-10-23WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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