Forticept Wounds and Burns Hydrogel
- Product NDC
- 72127-0803
- 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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 72127-0803-0 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 72127-0803-1 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 72127-0803-0 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 72127-0803-1 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 72127-0803-0 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 72127-0803-1 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 72127-0803-0 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 72127-0803-1 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 72127-0803-1 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 72127-0803-0 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 72127-0803-1 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 72127-0803-0 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 72127-0803-1 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 72127-0803-0 | U | Excluded because listing certification expired | 0efc9e666f02… | 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 |
|---|---|
| BENZETHONIUM CHLORIDE | .001 kg/kg |
| LIDOCAINE | .04 kg/kg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| PH41D05744 | Internal UNII lookup |
| 98PI200987 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 72127-0803-0 | 2025-03-25 | Forticept Wounds and Burns Hydrogel |
| 72127-0803-1 | 2025-03-25 | Forticept Wounds and Burns Hydrogel |
| 72127-0803-0 | 2025-01-30 | Forticept Wounds and Burns Hydrogel |
| 72127-0803-1 | 2025-01-30 | Forticept Wounds and Burns Hydrogel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72127-0803-0 | Forticept Wounds and Burns Hydrogel | 0.114 kg in 1 TUBE | GEL | 0.114 | 5 | |
| 72127-0803-1 | Forticept Wounds and Burns Hydrogel | 0.085 kg in 1 TUBE | GEL | 0.085 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72127-0803 | FORTICEPT WOUNDS AND BURNS HYDROGEL (BENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) GEL [LIDAN, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250327_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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pain Relieving Cooling | MENTHOL, UNSPECIFIED FORM | J.R. Watkins, LLC. | 3574d48a-b546-4ea7-b470-071bb328de64 | 2024-02-08 | Warnings | M017 |
| Advil Targeted Relief | CAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATE | Haleon US Holdings LLC | 16e6be21-7b43-443a-89ec-3bdf0ec0dfc1 | 2024-02-08 | Warnings | M017 |
| POINT RELIEF COLD SPOT Pain Relieving | MENTHOL | FABRICATION ENTERPRISES | 96f1d592-6cec-412e-a5fd-cf3c4f68644f | 2024-02-07 | Warnings | M017 |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Safetec of America, Inc. | 1c5eb3b3-79b3-472a-ae36-ec6a7dc72925 | 2024-02-07 | Warnings | M017 |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Safetec of America, Inc. | 8eb3e7e2-26e5-430e-89aa-40a0367c637e | 2024-02-07 | Warnings | M017 |
| Nova Natura Topical Analgesic | CAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATE | SEYITLER KIMYA SANAYI ANONIM SIRKETI | abf00f73-f0b1-439e-85aa-bbce8a1ec920 | 2024-02-06 | Warnings | M017 |
| Leader Burn Relief | LIDOCAINE | Cardinal Health | f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2 | 2024-02-06 | Warnings | M017 |
| Pain Relieving Petro Carbo | PHENOL | J.R. Watkins, LLC. | 050cf17d-3be7-45b9-8524-ad82af309a0e | 2024-02-06 | Warnings | M017 |
| White Cream | CAMPHOR (NATURAL) AND TURPENTINE OIL | J.R. Watkins, LLC. | e4de0734-59d5-478c-86ea-66fc2ba003e7 | 2024-02-05 | Warnings | M017 |
| Pain Relieving Roll-On | MENTHOL, UNSPECIFIED FORM | Safetec of America, Inc. | 80118260-9c88-402d-9a90-ecfe62b4b54f | 2024-02-05 | Warnings | M017 |
| Pain Relieving | MENTHOL, UNSPECIFIED FORM | Safetec of America, Inc. | df512ce6-ce1b-434d-9571-fb2e1d76e1d0 | 2024-02-05 | Warnings | M017 |
| Pain Relieving | MENTHOL | Safetec of America, Inc. | 52ebf64d-095f-467e-bf51-dd8d33b58c7d | 2024-02-05 | Warnings | M017 |
| Itch Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Safetec of America, Inc. | 4f4c801b-d894-4fa3-b024-6ca41a5f2a95 | 2024-02-04 | Warnings | M017 |
| Analgesic | MENTHOL | Safetec of America, Inc. | 79e3b0e7-4ba5-4b9d-a980-5b6f18dba802 | 2024-02-04 | Warnings | M017 |
| HAV EZ Penetrating Pain Relief | MENTHOL | PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC | 70006efc-9cc8-4490-b28c-fcb23b1737c4 | 2024-02-01 | Warnings | M017 |
| Rugby Capsaicin External Analgesic | CAPSAICIN | Proficient Rx LP | 7c733a30-5002-49e7-a6bd-7737a1d2461e | 2024-02-01 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Proficient Rx LP | ccb62898-b614-45b9-95ea-23e5e31893a8 | 2024-02-01 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE | Proficient Rx LP | 0b26d92f-9d0e-46d4-a8bc-75d6da5f6199 | 2024-02-01 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Proficient Rx LP | c57d5f8e-5934-4cbb-999a-cdd55e5b105f | 2024-02-01 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Proficient Rx LP | 47e9fe84-bd0c-40ea-85de-e950bcacc557 | 2024-02-01 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72127-0803-0 | 72127080300 | .114 kg in 1 TUBE (72127-0803-0) | 2020-05-06 | 0000-00-00 | No | No | Current |
| 72127-0803-1 | 72127080301 | .085 kg in 1 TUBE (72127-0803-1) | 2021-02-18 | 0000-00-00 | No | No | Current |