FDA.reportPublic FDA data

Forticept Wounds and Burns Hydrogel

Product NDC
72127-0803
Requested package NDC
72127-0803-1
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 3 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINECardinal Health, 110 dba LEADER025d508b-ec4f-466c-b3e8-ba9b18d07b462026-08-26WarningsExact identifier
application number: M017
Inknows Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.59eb9c12-9e00-0171-e063-6394a90a83422026-08-25WarningsExact identifier
application number: M017
LidomarLIDOMAROncora Pharma, LLC215bfdca-60bf-480b-b02e-902de52fe5e82026-08-25WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAmazon.com Services LLC5f87d7fb-f258-48b0-8b60-1055e22ebd712026-08-25WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c7e13f-b9ea-023a-e063-6294a90a79e02026-08-24WarningsExact identifier
application number: M017
KNEE PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c8b33a-7d4f-2c6e-e063-6394a90a79292026-08-24WarningsExact identifier
application number: M017
Bovonte Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5958cc29-c449-56a7-e063-6394a90a960b2026-08-24WarningsExact identifier
application number: M017
HUSTLE BUTTER NUMBINGLIDOCAINE HYDROCHLORIDEH.B.D. D.I.S.T. INC.d7dfb312-6c80-4a2d-b8b2-d9891cb0b74e2026-08-24WarningsExact identifier
application number: M017
JELVOXA NECK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.59a3d60a-26b5-e6a6-e063-6294a90a42bd2026-08-22WarningsExact identifier
application number: M017
JELVOXA DMSOCAMPHOR CAPSAICIN MENTHOLWuhan Ruihengjie Technology Co., Ltd.59a43e2c-d258-34b5-e063-6394a90a09bf2026-08-22WarningsExact identifier
application number: M017
Capsaicin 0.035 PercentCAPSAICINPreferred Pharmaceuticals Inc.0fabc025-4208-45f5-b3c2-543ae3a2df412026-08-21WarningsExact identifier
application number: M017
ClaravieHYDROCORTISONE ACETATEGentell LLC598d224b-d12e-89bf-e063-6394a90a84dc2026-08-21WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVINGMENTHOL, CAMPHORWorldwide Cosmetics, Inc3b8c2419-7a78-2731-e054-00144ff8d46c2026-08-21WarningsExact identifier
application number: M017
PARCHE FRIOMETHYL SALICYLATE, MENTHOL, AND CAMPHOR PATCHDW SUPPORT LLC5970a6f7-b273-9bb1-e063-6394a90afc792026-08-21WarningsExact identifier
application number: M017
Enokon Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.5976e667-e506-1d11-e063-6394a90a68092026-08-20WarningsExact identifier
application number: M017
MQUPIN TIGER PatchTIGER PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5977cbb5-94c7-cb24-e063-6294a90a2e072026-08-20WarningsExact identifier
application number: M017
MQUPIN Nicotine PatchesNICOTINE PATCHESZhengzhou Miaoqi Medical Technology Co., Ltd.5978258a-549e-50e6-e063-6394a90a3d862026-08-20WarningsExact identifier
application number: M017
ClaravieCAMPHORGentell LLC5978bdab-5359-be9a-e063-6394a90a5a322026-08-20WarningsExact identifier
application number: M017
Rugby PAIN RELIEF PATCHESLIDOCAINERUGBY LABORATORIESb34e40c8-a257-46cf-9399-f55df9b4102d2026-08-20WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72127-0803-172127080301.085 kg in 1 TUBE (72127-0803-1) 2021-02-180000-00-00NoNoCurrent