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.
| 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 |
|---|---|---|---|---|---|---|
| Westlake Anti-itch | HYDROCORTISONE | Westlake Pharma LLC | 0c53c982-3f23-a2d5-e063-6394a90acd55 | 2023-12-12 | Warnings | M017 |
| Rite Aid Anti-itch | HYDROCORTISONE | Rite Aid | 0c540422-1579-9217-e063-6294a90ad06a | 2023-12-12 | Warnings | M017 |
| Anti-itch Paraben Free | HYDROCORTISONE | Weeks & Leo Co., Inc. | 0c5419c5-0929-7ca6-e063-6294a90ac0a7 | 2023-12-12 | Warnings | M017 |
| Rite Aid Hydrocortisone | HYDROCORTISONE 1% | Rite Aid | 0c580f96-7fe9-19df-e063-6394a90a5a22 | 2023-12-12 | Warnings | M017 |
| Anti itch | HYDROCORTISONE | Weeks & Leo Co., Inc. | 0c58b750-d3a6-5ed1-e063-6294a90a4321 | 2023-12-12 | Warnings | M017 |
| Greencaine Blast | LIDOCAINE | ALMA Laboratories, Inc. | 031e0065-4c8a-43d8-bc69-3efa3c6c0ae3 | 2023-12-12 | Warnings | M017 |
| Ageless Pain Relief | METHYL SALICYLATE, MENTHOL | Isagenix International, LLC | 3c7e493b-923d-44b1-9076-46c7894308d4 | 2023-12-12 | Warnings, Adverse reactions | M017 |
| CVS Extra Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | CVS | 857af609-9dd7-a07a-e053-2991aa0ab6ba | 2023-12-11 | Warnings | M017 |
| Rite Aid Extra Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Rite Aid | 0c4170dd-e1fa-d549-e063-6394a90a5c23 | 2023-12-11 | Warnings | M017 |
| Westlake Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | Westlake HB Pharma LLC | 0c416ba6-b01f-0609-e063-6294a90ae2a1 | 2023-12-11 | Warnings | M017 |
| CVS Regular Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | CVS | 87473ace-d834-e43f-e053-2a95a90a819c | 2023-12-11 | Warnings | M017 |
| Katinko External Analgesic Oil | CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE | Greenstone Pharmaceutical Inc. | 5881fc35-3293-4f0b-801a-afcd6feb9496 | 2023-12-08 | Warnings | M017 |
| Katinko Pain And Itch Relieving | CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE | Greenstone Pharmaceutical Inc. | fe907fa4-4a01-4974-b71f-9cd980b4eaa2 | 2023-12-08 | Warnings, Adverse reactions | M017 |
| Cycle | MENTHOL | La Mend, Inc. | cfc0bcde-ef91-1e6c-e053-2a95a90ab79e | 2023-12-07 | Warnings | M017 |
| Hemorrhoidal Pain Relief Cream | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | WALGREENS | 03bbe146-f185-bcfa-e063-6394a90a85bf | 2023-12-04 | Warnings | M017 |
| Quatriderm Anti-itch | HYDROCORTISONE | OPMX LLC | 83e59e10-9878-e5c2-e053-2a91aa0af25e | 2023-12-04 | Warnings | M017 |
| TACT | DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL | Sato Pharmaceutical Inc., Ltd. | b6e2ee24-69de-4dfd-9081-b9537b7a7bad | 2023-12-04 | Warnings | M017 |
| Overnight Cold Therapy Pain Relief | MENTHOL, UNSPECIFIED FORM | Walgreen Co. | 2cbd0966-4cf9-4271-bd53-6672b1ed2a99 | 2023-12-04 | Warnings | M017 |
| Prolayed Lidocaine Male Genital Desensitizer | LIDOCAINE | ViaDerma Distribution, Inc. | 9c5ad0d0-ca7a-4321-9334-f06f3f6be18f | 2023-12-02 | Warnings | M017 |
| Liberdol Topical Analgesic | METHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC) | ViaDerma Distribution, Inc | ab52cd0e-34fa-41c7-9ce7-1183c2aff8d8 | 2023-12-01 | 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 |