NDC 10122-310-01 - FILSUVEZ

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
10122-310
Requested NDC
10122-310-01
Package NDCs from labels
10122-310-01, 10122-310-02
Manufacturer
Chiesi USA, Inc. | Eurofins BioPharma Product Testing Hamburg GmbH | Amryt GmbH | BioChem Labor für biologische und chemische Analytik GmbH | Nuvisan GmbH | Lichtenheldt GmbH | Synergy Health Radeberg GmbH | Pharma Packaging Solutions (Carton Service, Inc.) | CIT SRL
Effective date
2026-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FILSUVEZChiesi USA, Inc. | Eurofins BioPharma Product Testing Hamburg GmbH | Amryt GmbH | BioChem Labor für biologische und chemische Analytik GmbH | Nuvisan GmbH | Lichtenheldt GmbH | Synergy Health Radeberg GmbH | Pharma Packaging Solutions (Carton Service, Inc.) | CIT SRL2026-07-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10122-310-01FILSUVEZ23.4 g in 1 TUBEGEL23.41
10122-310-02FILSUVEZ1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10122-310FILSUVEZ (BIRCH TRITERPENES) GEL [CHIESI USA, INC.]1Current NDC, 2 package rows20240522_32ba9194-734c-47d4-84e1-b21e28a85ec5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10122-310-01GM - Gram10122-310abb317f9-237a-4585-9eb6-4a42536a3bf212024-06-10
10122-310-02GM - Gram10122-310ca5c32e7-de34-4524-9ce2-a7699709438412024-06-10

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 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FILSUVEZBIRCH TRITERPENESChiesi USA, Inc.32ba9194-734c-47d4-84e1-b21e28a85ec52026-07-24Warnings, Adverse reactionsExact identifier
application number: NDA215064
ndc (package): 10122-310-01
ndc (package): 10122-310-02
ndc (product): 10122-310
ndc11 (package): 10122031001
rxcui: 2675587
rxcui: 2675592
spl id: 14e5440b-aa04-4c95-92f6-c7f1ed9f7252
spl set id: 32ba9194-734c-47d4-84e1-b21e28a85ec5
unii: BX09B0RQR0
Body Oil for Stretch MarksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILDongguan Xiaogoubeige trading company Ltd.496af9a1-7249-622f-e063-6394a90aa2842026-01-27WarningsExact identifier
unii: 3W1JG795YI
FILSUVEZBIRCH TRITERPENESAmryt Pharmaceuticals DACda793f2d-0a3d-4792-8c22-982f9f8cdd972026-01-20Warnings, Adverse reactionsExact identifier
application number: NDA215064
rxcui: 2675587
rxcui: 2675592
unii: BX09B0RQR0
EELHOE Airy SunstickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.45328c13-31ae-3bd2-e063-6394a90a814f2025-12-05WarningsExact identifier
unii: 3W1JG795YI
HOEGOA Hair Scalp Sunscreen MineralTITANIUM DIOXIDEGuangzhou Hoegoa Biotechnology Co., Ltd.44b37930-b302-338c-e063-6394a90a5f7f2025-11-28WarningsExact identifier
unii: 3W1JG795YI
HOUKEA Bee Venom Joint CreamGLYCERINGuangzhou Houkea Biotechnology Co., Ltd.322cb8b6-981b-0146-e063-6294a90a57852025-11-27WarningsExact identifier
unii: 3W1JG795YI
Tattoo careTATTOO CARE CREAMPerfso (HK) Co., Limited42d0f56f-9cb1-8e19-e063-6394a90aa3e02025-11-04WarningsExact identifier
unii: 3W1JG795YI
OrgaPlus Super Care Balm for combination and oi ly skin type 14gSUNFLOWERBLUEZONWIDE CO.,LTD10b39828-8a9c-44b0-aa2a-925a5593e8ab2025-02-05WarningsExact identifier
unii: 3W1JG795YI
OrgaPlus Super Care Balm for combination and oi ly skin type 20gSUNFLOWERBLUEZONWIDE CO.,LTD676e4d9f-62bc-4983-81fe-0d314ef468742025-02-05WarningsExact identifier
unii: 3W1JG795YI
Body Milk for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,THEOBROMA CACAO (COCOA) SEED BUTTERGuangzhou Senmai Biotechnology Co.1dcd94dc-214d-de72-e063-6294a90a695f2025-01-08WarningsExact identifier
unii: 3W1JG795YI
Body oil for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILGuangzhou Senmai Biotechnology Co.1daeb2e8-f18c-06c3-e063-6294a90a63852025-01-08WarningsExact identifier
unii: 3W1JG795YI
Massage cream for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL,BUTYROSPERMUM PARKII (SHEA) BUTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,CERAMIDE NP,SOLUBLE COLLAGEN,HYDROLYZED ELASTIN,PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OILGuangzhou Senmai Biotechnology Co.1dce7cf1-1fb8-e14e-e063-6394a90ae34a2025-01-08WarningsExact identifier
unii: 3W1JG795YI

Reported adverse events (FAERS/openFDA)#

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