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
2026-09-25
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 AG2026-09-25HUMAN 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 3 of 42 · 835 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcohol 70 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLC57c496b3-10ab-4a72-8d8f-42a2256189dd2026-08-06WarningsExact identifier
unii: ND2M416302
PROHEAL ALCOHOL PREP PADSISOPROPYL ALCOHOLClick Industries LLCd272c1f6-e9c9-4099-9d24-f5aae44082ae2026-08-05WarningsExact identifier
unii: ND2M416302
Tazza Antiseptic Hand WipesISOPROPYL ALCOHOLTazza Brands East Inc.c37c7599-58b6-58bb-e053-2a95a90af1cf2026-08-04WarningsExact identifier
unii: ND2M416302
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADVOCATE Sterile Alcohol Prep PadsISOPROPYL ALCOHOLPHARMA SUPPLY, INCa87dd40d-a9b1-4bb5-acc2-2d00abc2034a2026-07-30WarningsExact identifier
unii: ND2M416302
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
70% Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions57ac6fef-21de-e214-e063-6394a90a6c9e2026-07-28WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions LLC57acc1ff-2564-1e61-e063-6394a90a3c912026-07-28WarningsExact identifier
unii: ND2M416302
Pharma care IPA WipesISOPROPYL ALCOHOLEnviro Specialty Chemicals Inc26ce919a-1765-4b44-9114-24ea7383a9872026-07-24WarningsExact identifier
unii: ND2M416302
DOCTOR INKS IPA WIPESISOPROPYL ALCOHOLEnviro Specialty Chemicals Incf65f0ec4-fa2c-487d-a8cc-41cbb8c140a42026-07-24WarningsExact identifier
unii: ND2M416302
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.5738a502-c5ab-21b0-e063-6294a90a20a72026-07-22WarningsExact identifier
unii: ND2M416302
KeepGoing Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJ&A Digital Inc.a630db1b-1674-4659-a60f-56994b0a15642026-07-22WarningsExact identifier
unii: ND2M416302
KeepGoing Alcohol Prep PadISOPROPYL ALCOHOLJ&A Digital Inc.5d1e776b-4027-4d05-b02f-8a2701d7bc7a2026-07-22WarningsExact identifier
unii: ND2M416302
PROVEN MEDICAL TESTING Alcohol Prep PadsISOPROPYL ALCOHOLProven Medical Testing, LLC21e0f7ea-e73e-4461-ab2b-50d456e1d70d2026-07-22WarningsExact identifier
unii: ND2M416302
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Biopure 70% Isopropyl Alcohol WipeISOPROPYL ALCOHOL, WIPEQUEST USA CORP3a7932c4-6f90-a008-e063-6294a90aa7692026-07-19WarningsExact identifier
unii: ND2M416302
Alcohol Cleansing WipeISOPROPYL ALCOHOLHubei Fanjian Medical Product Co.,Ltd1607fb06-826b-42bb-986e-0023a1b078f32026-07-10WarningsExact identifier
unii: ND2M416302
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLSave-A-Lot Food Stores Ltda592326c-c062-4ebf-b8dd-83f7e6f2f22b2026-07-07Warnings, Adverse reactionsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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