FDA.reportPublic FDA data

REGRANEX 0.01 % Topical Gel

RxCUI
213197
RxNorm name
REGRANEX 0.01 % Topical Gel
Display name
REGRANEX 0.01 % Topical Gel
Full name
REGRANEX 0.01 % Topical Gel
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:54

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103691Regranexbecaplermin351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regranex Gel 0.01%BECAPLERMIN GEL 0.01%LRM Therapeutics, LLC377b3021-13d7-96d5-e063-6394a90a8ca32026-05-08Warnings, Adverse reactionsExact identifier
rxcui: 213197

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
377b3021-13d7-96d5-e063-6394a90a8ca3REGRANEX 0.01 % Topical GelPSN4These highlights do not include all the information needed to use REGRANEX ® gel safely and effectively. See full prescribing information for REGRANEX gel. REGRANEX (becaplermin) gel, for topical use Initial U.S. Approval: 199720260508
377b3021-13d7-96d5-e063-6394a90a8ca3Regranex 0.0001 MG/MG Topical GelSY4These highlights do not include all the information needed to use REGRANEX ® gel safely and effectively. See full prescribing information for REGRANEX gel. REGRANEX (becaplermin) gel, for topical use Initial U.S. Approval: 199720260508
377b3021-13d7-96d5-e063-6394a90a8ca3Regranex 100 MCG per GM Topical GelSY4These highlights do not include all the information needed to use REGRANEX ® gel safely and effectively. See full prescribing information for REGRANEX gel. REGRANEX (becaplermin) gel, for topical use Initial U.S. Approval: 199720260508
377b3021-13d7-96d5-e063-6394a90a8ca3Regranex 0.01 % Topical GelSY4These highlights do not include all the information needed to use REGRANEX ® gel safely and effectively. See full prescribing information for REGRANEX gel. REGRANEX (becaplermin) gel, for topical use Initial U.S. Approval: 199720260508
377b3021-13d7-96d5-e063-6394a90a8ca3becaplermin 0.0001 MG/MG Topical Gel [Regranex]SBD4These highlights do not include all the information needed to use REGRANEX ® gel safely and effectively. See full prescribing information for REGRANEX gel. REGRANEX (becaplermin) gel, for topical use Initial U.S. Approval: 199720260508