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.
| Captured / source date | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 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 |
|---|---|---|---|---|---|---|
| Calypxo Pain Relief | METHYL SALICYLATE, MENTHOL | Advanced Rx of Tennessee, LLC | 0b7736df-c7e0-7d00-e063-6294a90aa57e | 2024-12-31 | Warnings | M017 |
| New Terocin | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | Advanced Rx Pharmacy of Tennessee, LLC | f4bfc4a6-06ef-1f76-e053-2995a90a2b8f | 2024-12-31 | Warnings | M017 |
| Lidocaine | LIDOCAINE | Advanced Rx Pharmacy of Tennessee, LLC | 01cb19a4-ce22-144d-e063-6294a90a8aa3 | 2024-12-31 | Warnings | M017 |
| Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream | LIDOCAINE, MENTHOL | Sato Pharmaceutical Co., Ltd. | 2251e96b-d050-4ec2-a6b9-6659610885bf | 2024-12-30 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Safeway | af2e2ef3-0f3f-4592-8081-b6553ade2f5a | 2024-12-26 | Warnings | M017 |
| Comforte Menstrual Cramp Relief Cream | MENTHOL | PMS4PMS LLC | c121537e-3333-4f35-8c77-20086158dff4 | 2024-12-26 | Warnings | M017 |
| N-Labs Arcticzen Pain Relief Knee | CAMPHOR (SYNTHETIC), MENTHOL | NUTRIOMO LABS PTE. LTD | 05ee574a-854c-4a77-be77-082055075c4d | 2024-12-26 | Warnings | M017 |
| BiteMD External Analgesic First Aid Antiseptic | BENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOL | United Industries Corporation | 4c60db03-6d2b-4ae0-a200-718b3a50eb0f | 2024-12-23 | Warnings | M017 |
| GNP Anti Itch | CAMPHOR, MENTHOL | AMERISOURCEBERGEN DRUG CORPORATION | b4f2d6f7-2287-47d8-e053-2995a90ae335 | 2024-12-23 | Warnings | M017 |
| cool and heat pain relieving liquid | MENTHOL | Bionpharma Inc. | ec6f59d8-45c5-46a0-e053-2995a90a239f | 2024-12-23 | Warnings | M017 |
| FOOT WORKS MAXIMUM CRACKED HEEL | BENZALKONIUM CHLORIDE, LIDOCAINE | COSMAX USA, CORPORATION | 29f92230-d1d4-5e94-e063-6294a90af812 | 2024-12-23 | Warnings | M017 |
| pain relief roll-on | LIDOCAINE 4% | Bionpharma Inc. | f607b6dc-8d13-604a-e053-2995a90a59ab | 2024-12-23 | Warnings | M017 |
| Veneno de Abeja Aceite De Vibora Brand | METHYL SALICYLATE | Miramar Cosmetics, Inc DBA Miramar Lab | a6c4889c-e7a9-44b9-bd9a-70fd6e8c4825 | 2024-12-23 | Warnings | M017 |
| Itch Relief | HYDROCORTISONE 1% | Trifecta Pharmaceuticals USA LLC | af5daf6c-bcad-8ebf-e053-2a95a90af1b0 | 2024-12-20 | Warnings | M017 |
| Pain Itch Relief | LIDOCAINE HCI | Trifecta Pharmaceutical USA LLC | f40b19a8-795c-f514-e053-2a95a90a6d15 | 2024-12-20 | Warnings | M017 |
| Muscle Rub Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Trifecta Pharmaceuticals USA, LLC. | 44d3638d-f29b-0e01-e054-00144ff88e88 | 2024-12-20 | Warnings | M017 |
| Rhuli Gel | CAMPHOR, MENTHOL | Trifecta Pharmaceuticals USA, LLC. | 4fbb3c23-ed47-336e-e054-00144ff8d46c | 2024-12-20 | Warnings | M017 |
| Hydrocortisone Cream with Aloe | HYDROCORTISONE | Rugby Laboratories | 132982ea-cce6-687c-e063-6294a90a4632 | 2024-12-20 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Pharmacy Value Alliance LLC | 9bb98452-a605-5c20-e053-2995a90a1ea7 | 2024-12-20 | Warnings | M017 |
| DCH Cooling Pain Relief | MENTHOL 10.5% | Derma Care Research Labs, LLC | 00dcdae0-c744-8402-e063-6294a90a12f8 | 2024-12-20 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72127-0803-1 | 72127080301 | .085 kg in 1 TUBE (72127-0803-1) | 2021-02-18 | 0000-00-00 | No | No | Current |