WelAhead by Welmate Lidocaine 5% Roll-on
- Product NDC
- 83833-101
- 11-digit product format
- 838330101
- Labeler code
- 83833
- Product ID
- 83833-101_35a93f2b-396d-1532-e063-6394a90a7c83
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lidocaine 5%
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- OTC PHARM LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-12-01
- Substance
- LIDOCAINE HYDROCHLORIDE ANHYDROUS
- Active strength
- 5 g/100mL
- 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 | 83833-101-03 | 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 | 83833-101-03 | 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 | 83833-101-03 | 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 | 83833-101-03 | 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 | 83833-101-03 | 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 | 83833-101-03 | 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 | 83833-101-03 | 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
- WelAhead by Welmate Lidocaine 5% Roll-on
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIDOCAINE HYDROCHLORIDE ANHYDROUS | 5 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| EC2CNF7XFP | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2670601 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0b75e83e-8c7b-6247-e063-6294a90ac413 | 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 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 83833-101-03 | 2025-05-21 | C162847 | 48780-1 | 2cef2736-9cff-d83d-e063-dadaa90ab31f | WelAhead by Welmate Lidocaine 5% Roll-on 83833-101 |
| 83833-101-03 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9cff-d83d-e063-dadaa90ab31f | WelAhead by Welmate Lidocaine 5% Roll-on 83833-101 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83833-101-03 | WelAhead by Welmate Lidocaine 5% Roll-on | 90 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION | 90 | 2 |
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 |
|---|---|---|---|---|---|---|
| Lidocaine Pain Relief Roll-On | LIDOCAINE 4% | Humco Holding Group, Inc. | a8be9e46-1616-40a9-e053-2a95a90ac3bc | 2023-12-15 | Warnings | M017 |
| Hot/Cold Menthol 16% Roll-On | HOT/COLD MENTHOL 16% ROLL-ON | Humco Holding Group, Inc | a8bf9744-9979-13c1-e053-2a95a90a30aa | 2023-12-15 | Warnings | M017 |
| Freds Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | Discount Drug Mart | 8697b932-da5a-717e-e053-2a91aa0afcae | 2023-12-12 | Warnings | M017 |
| CVS Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | CVS | 86972218-31fe-6942-e053-2991aa0a8850 | 2023-12-12 | Warnings | M017 |
| Best Choice Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | value merchandisers | 869631f8-aa1e-8ea4-e053-2a91aa0a5c57 | 2023-12-12 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Weeks & Leo Co., Inc. | 0c5325e3-4796-856c-e063-6394a90a1f90 | 2023-12-12 | Warnings | M017 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2670601 | lidocaine HCl 5 % Topical Solution | PSN | 0b75e83e-8c7b-6247-e063-6294a90ac413 | 2 |
| 2670601 | lidocaine hydrochloride 50 MG/ML Topical Solution | SCD | 0b75e83e-8c7b-6247-e063-6294a90ac413 | 2 |
| 2670601 | lidocaine hydrochloride 5 % Topical Solution | SY | 0b75e83e-8c7b-6247-e063-6294a90ac413 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83833-101-03 | 83833010103 | 90 mL in 1 BOTTLE, WITH APPLICATOR (83833-101-03) | 90 ml | 2023-12-01 | No | No | Current |