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 26 of 42 · 835 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HCS Alcohol Prep Pad LargeISOPROPYL ALCOHOLConcordance Healthcare Solutions, LLC.2cbe0c4c-440d-4f6c-88e8-363d3c798fba2025-05-27WarningsExact identifier
unii: ND2M416302
VLITEPRO First Aid WipesISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co., Ltd.35a7873a-e340-aae3-e063-6294a90a767f2025-05-26WarningsExact identifier
unii: ND2M416302
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: OJ245FE5EU
Isopropyl AlcoholISOPROPYL ALCOHOLSafeway, Inc.29e5c152-15d7-4080-abf0-f76f8e9cbf5a2025-05-16WarningsExact identifier
unii: ND2M416302
Isopropyl Alcohol WintergreenISOPROPYL ALCOHOLSafeway, Inc.14a22d1e-e498-4661-ab30-6696b8b914d72025-05-16WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLSafeway, Inc.69295fa8-0f0f-495c-a2ef-1414c6fa93a42025-05-16WarningsExact identifier
unii: ND2M416302
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOmnivium Pharmaceuticals LLC8fafc39b-69db-40f3-8a09-ee859e8cef192025-05-15Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Maokang Alcohol Prep Pad Saturated with 70% Isopropyl AlcoholISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltda13a971c-769a-4909-8980-9e8bec4a03612025-05-09WarningsExact identifier
unii: ND2M416302
ALCOHOL PREP PADS LARGE STERILEISOPROPYL ALCOHOL CLOTHHUZHOU JUNDA INDUSTRY CO., LTD.367ab42b-46fe-90f7-e063-6394a90ad2032025-05-01WarningsExact identifier
unii: ND2M416302
Germ Attack 70% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375d44e-5af6-8c7f-e063-6394a90abb4b2025-04-25WarningsExact identifier
unii: ND2M416302
Germ Attack 91% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375e0d7-07fa-6489-e063-6294a90a91ec2025-04-25WarningsExact identifier
unii: ND2M416302
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.3347184c-ae72-bec2-e063-6294a90a2d052025-04-23WarningsExact identifier
unii: ND2M416302
Dukal Sterile Alcohol Prep PadISOPROPYL ALCOHOLDukal LLC00b2c444-8601-4d8f-b6bb-91b864fd90412025-04-23WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTARGET Corporation126ec829-c54c-4927-bbd5-a8156d2f6eea2025-04-14WarningsExact identifier
unii: ND2M416302
Be Smart Get Prepared Alcohol Prep PadISOPROPYL ALCOHOLTotal Resources International, Inc6f2a4cb9-eea9-4894-b774-759f27b6f9a82025-04-14WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC9c85129b-29fa-4393-a9b4-b8ea1ba5be542025-04-14WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLTARGET Corporationf4ea4aa4-42c6-456b-9908-24f256d4a7692025-04-14WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol WintergreenISOPROPYL ALCOHOLStrategic Sourcing Services LLC8dac7168-0140-470f-bf66-fd0aed519b382025-04-14WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC227b9292-0be7-47ef-ac8e-a9a8cc2fb4162025-04-14WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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