Lidozen
- Product NDC
- 63187-892
- 11-digit product format
- 631870892
- Labeler code
- 63187
- Product ID
- 63187-892_de5d688d-8c71-4bf5-999c-17a3f323f854
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LIDOCAINE HYDROCHLORIDE, MENTHOL
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Proficient Rx LP
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-07-22
- Substance
- LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
- Active strength
- 40; 10 mg/mL; mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 63187-892 | 63187-892-64 | D | Discontinued by firm | 2026-10-16 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Lidozen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIDOCAINE HYDROCHLORIDE | 40 mg/mL |
| MENTHOL, UNSPECIFIED FORM | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V13007Z41A | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1ebb45e5-4541-4c95-abe1-661ef763a610 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 070fbed5-7088-434a-a7ce-f2a64d8d40ac | Product name | 2 | 20260107 |
| bee66ce1-adb7-9d3b-67d9-582e4c54e80f | Product name | 5 | 20250819 |
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 7d755fa1-1087-4dcd-98f0-6d4bba479a57 | Product name | 3 | 20210602 |
| aed701d5-9c75-dfaf-7154-cde46179faea | Product name | 9 | 20200313 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 49fa150c-f0de-cce7-3d9c-993ed81c5698 | Product name | 1 | 20140508 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63187-892-64 | Lidozen | 120 mL in 1 BOTTLE | GEL | 120 | 8 | |
| 63187-892-64 | Lidozen | 2 in 1 BOX | GEL | 2 | 8 | |
| 63187-892-72 | Lidozen | 120 mL in 1 BOTTLE | GEL | 120 | 8 | |
| 63187-892-72 | Lidozen | 1 in 1 BOX | GEL | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63187-892-64 | ML - Milliliter | 63187-892 | 25d9fcac-9517-4481-a303-b53caae753b7 | 1 | 2021-02-05 |
| 63187-892-72 | ML - Milliliter | 63187-892 | d8290353-b1db-4b54-9b2d-5642f12be407 | 1 | 2017-10-13 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| BLT 2 | LIDOCAINE HCL | CENTURA PHARMACEUTICALS INC | 41dc85ec-d79b-0a32-e054-00144ff8d46c | 2026-01-12 | Warnings | M017 |
| Mineral Ice Pain Relieving | MENTHOL | Crown Laboratories | 7b30076a-0af6-2f74-e053-2a91aa0ae08d | 2026-01-12 | Warnings | M017 |
| Sarna | PRAMOXINE HYDROCHLORIDE | Crown Laboratories | 19b0ce1b-e147-01a1-e063-6394a90af808 | 2026-01-12 | Warnings | M017 |
| Sarna | PRAMOXINE HYDROCHLORIDE, MENTHOL | Crown Laboratories, Inc | 19c41e75-a654-90cf-e063-6394a90a7e97 | 2026-01-12 | Warnings | M017 |
| Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | HY-VEE, INC | 48350b54-8d9a-48c4-e063-6394a90ac040 | 2026-01-12 | Warnings | M017 |
| LidoPlus Pain Relief | LIDOCAINE HYDROCHLORIDE | Centura Pharmaceuticals, Inc | 07bacc6c-60a6-4297-8663-904a22bdc040 | 2026-01-12 | Warnings | M017 |
| BlueStop Max | EXTERNAL ANALGESIC | Clavel Corporation | f1efb51c-5217-4cb2-e053-2a95a90a7f95 | 2026-01-12 | Warnings | M017 |
| BlueStop Max | EXTERNAL ANALGESIC | Clavel Corporation | f2277e27-868b-57ef-e053-2a95a90abf28 | 2026-01-12 | Warnings | M017 |
| BLT 3 | TETRACAINE | CENTURA PHARMACEUTICALS INC | 401a0d22-1181-02ac-e054-00144ff88e88 | 2026-01-12 | Warnings | M017 |
| Sting Relief Prep Pad | BENZOCAINE | NINGBO TIANBO FIRST AID PRODUCT CO., LTD. | 0c901f64-6890-45c0-9ca7-ee9de87903c4 | 2026-01-12 | Warnings | M017 |
| Goodsense Oral Pain Relief | BENZOCAINE | Geiss, Destin and Dunn, Inc. | eb461b70-d10f-4e11-8374-e43713f3504d | 2026-01-12 | Warnings | M017 |
| Extra Strength Balm | CAPSICUM AND MENTHOL | Saje Natural Business Inc | f516e416-446b-8f21-e053-2a95a90afd88 | 2026-01-12 | Warnings | M017 |
| Pain Release | MENTHOL | Saje Natural Business Inc. | 3df0e56a-7651-42dc-8ed8-f68836a63c61 | 2026-01-12 | Warnings | M017 |
| Trauma Less | MENTHOL | Saje Natural Business Inc. | 650cba4c-6aba-48c3-9c41-841f19905548 | 2026-01-12 | Warnings | M017 |
| Mamisan | LIDOCAINE HYDROCHLORIDE, MENTHOL | Miramar Cosmetics, Inc DBA Miramar Lab | 4402e900-c6e9-4f32-8cc4-c84014384a9f | 2026-01-12 | Warnings | M017 |
| Curist Lidocaine Patch | LIDOCAINE 4% PATCH | Little Pharma, Inc. | 1a8fe44e-7a21-c2ab-e063-6394a90a6100 | 2026-01-11 | Warnings | M017 |
| DG Health Pain Relieving | LIDOCAINE HCL | DOLGENCORP, LLC | 923aeb4c-049f-4ecc-a77e-9ffa0e236d4e | 2026-01-11 | Warnings | M017 |
| Campho-Phenique Antiseptic | CAMPHOR (SYNTHETIC) AND PHENOL | Foundation Consumer Healthcare | 46b84e0b-78a9-4cde-9f90-e165b5419162 | 2026-01-09 | Warnings | M017 |
| MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-On | MENTHOL | Inspec Solutions | 12ff9b9a-73e5-ce31-e063-6294a90aeaf8 | 2026-01-09 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), WHITE PETROLATUM | Carma Laboratories, Inc. | bb0278c9-eaff-d435-e053-2995a90a202a | 2026-01-09 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1373137 | lidocaine HCl 4 % / menthol 1 % Topical Gel | PSN | 1ebb45e5-4541-4c95-abe1-661ef763a610 | 8 |
| 1939340 | LidozenGel 4 % / 1 % Topical Gel | PSN | 1ebb45e5-4541-4c95-abe1-661ef763a610 | 8 |
| 1939340 | lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen] | SBD | 1ebb45e5-4541-4c95-abe1-661ef763a610 | 8 |
| 1373137 | lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel | SCD | 1ebb45e5-4541-4c95-abe1-661ef763a610 | 8 |
| 1373137 | lidocaine hydrochloride 4 % / menthol 1 % Topical Gel | SY | 1ebb45e5-4541-4c95-abe1-661ef763a610 | 8 |
| 1939340 | Lidozen 4 % / 1 % Topical Gel | SY | 1ebb45e5-4541-4c95-abe1-661ef763a610 | 8 |
| 1939340 | LidozenGel 4 % / 1 % Topical Gel | SY | 1ebb45e5-4541-4c95-abe1-661ef763a610 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63187-892-64 | 63187089264 | 2 BOTTLE in 1 BOX (63187-892-64) > 120 mL in 1 BOTTLE | 2 bottle | 2020-11-13 | 0000-00-00 | No | No | Current |
| 63187-892-72 | 63187089272 | 1 BOTTLE in 1 BOX (63187-892-72) / 120 mL in 1 BOTTLE | 1 bottle | 2017-08-01 | 0000-00-00 | No | No | Current |