FDA.reportPublic FDA data

Forticept Wounds and Burns Hydrogel

Product NDC
72127-0803
Requested package NDC
72127-0803-0
11-digit product format
721270803
Labeler code
72127
Product ID
72127-0803_3b775197-f88c-4e50-a12d-c44925706e8b
Type
HUMAN OTC DRUG
Nonproprietary name
BENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
Lidan, inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-06
Substance
BENZETHONIUM CHLORIDE; LIDOCAINE
Active strength
.001; .04 kg/kg; kg/kg
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Forticept Wounds and Burns Hydrogel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE.001 kg/kg
LIDOCAINE.04 kg/kg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PH41D05744Internal UNII lookup
98PI200987Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c6f58b63-9838-4ff4-8b1a-de2d41d6cf5fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
72127-0803-02025-03-25Forticept Wounds and Burns Hydrogel
72127-0803-12025-03-25Forticept Wounds and Burns Hydrogel
72127-0803-02025-01-30Forticept Wounds and Burns Hydrogel
72127-0803-12025-01-30Forticept Wounds and Burns Hydrogel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72127-0803-0Forticept Wounds and Burns Hydrogel0.114 kg in 1 TUBEGEL0.1145
72127-0803-1Forticept Wounds and Burns Hydrogel0.085 kg in 1 TUBEGEL0.0855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72127-0803FORTICEPT WOUNDS AND BURNS HYDROGEL (BENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) GEL [LIDAN, INC.]5Current NDC, Legacy NDC, 2 package rows20250327_c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f.zip

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 70 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aromalief Pain Relief Cream Orange GingerMENTHOLMarketites LLC9e8d3611-ef1b-4ac6-e053-2995a90af28a2025-10-29WarningsExact identifier
application number: M017
Aromalief Calming Pain Relief Cream LavenderMENTHOLMarketites LLCb8197d52-ccfb-b008-e053-2995a90a0a532025-10-29WarningsExact identifier
application number: M017
Aromalief Cozy Vanilla Pain Relief CreamMENTHOLMarketites LLC3634e55e-8c62-a782-e063-6394a90a65082025-10-29WarningsExact identifier
application number: M017
BENOVA PAIN AND ITCH RELIEFMENTHOL, 0.11%BENOVA RX LLC42513ee2-8b40-a9f3-e063-6394a90a93862025-10-29WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINECVS Pharmacy7e9285fd-26d5-3eac-e053-2991aa0ae2db2025-10-29WarningsExact identifier
application number: M017
Coralite Ultra Strength Pain ReliefCAMPHOR MENTHOLUnited Exchange Corp.44ecf959-cc07-4adc-a500-075b2ee695482025-10-29WarningsExact identifier
application number: M017
GoodSense Pain ReliefLIDOCAINEGeiss, Destin & Dunn, Inc826f8da4-8468-ea0a-e053-2991aa0a66cb2025-10-28WarningsExact identifier
application number: M017
CALMADOLCAMPHOR, MENTHOL, METHYL SALICYLATEGRANDALL DISTRIBUTING, LLC31b7f84e-8b66-4d31-8e9c-279d0af2fe642025-10-28WarningsExact identifier
application number: M017
XRay DOLCAMPHOR, MENTHOL, AND METHYL SALICYLATEGenomma Lab USA, Inc.e07fef46-68d9-769c-e053-2a95a90aa0652025-10-28WarningsExact identifier
application number: M017
CVS Medicated HeatCAPSICUM EXTRACTCVS Pharmacy81cd1019-93a6-311b-e053-2991aa0a79972025-10-28WarningsExact identifier
application number: M017
Foster and ThriveLIDOCAINESTRATEGIC SOURCING SERVICES, LLCf950b072-d978-b629-e053-6394a90abfaf2025-10-28WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
application number: M017
PRMENTHOLAmphp, Inc6f5b9e08-c445-4fac-e053-2a91aa0aa7372025-10-27WarningsExact identifier
application number: M017
LidocaineBURN RELIEFFoodhold USAb25dc0df-02d0-41ac-b36c-2c04baa77ef22025-10-27WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREEFSA Store Inc.fb3548c8-f202-dc50-e053-6394a90a5b302025-10-27WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE CONTINUOUS SPRAYPremier Brands of America, Inc.d344f68b-9b62-3029-e053-2995a90a16652025-10-27WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATE 1%Unifirst First Aid Corporationf2b46d69-1c21-5ae9-e053-2a95a90a60a92025-10-24WarningsExact identifier
application number: M017
Extra StrengthMENTHOL AND METHYL SALICYLATESaje Natural Business Inc.87d872b3-3231-d0f2-e053-2995a90a9d982025-10-24WarningsExact identifier
application number: M017
Coralite Muscle and Joint Pain ReliefCAMPHOR, MENTHOL, AND MEHTYL SALICYLATEUnited Exchange Corporation78edeeb8-3e3c-64bb-e053-2a91aa0a7bbc2025-10-24WarningsExact identifier
application number: M017
Coralite Odor Free Pain ReliefLIDOCAINEUnited Exchange Corporation7966d9f2-22f9-a900-e053-2991aa0aba552025-10-24WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72127-0803-072127080300.114 kg in 1 TUBE (72127-0803-0) 2020-05-060000-00-00NoNoCurrent