Burn Jel
- Product NDC
- 59898-200
- Requested package NDC
- 59898-200-17
- 11-digit product format
- 598980200
- Labeler code
- 59898
- Product ID
- 59898-200_2b0a5dfa-c7dd-d8e6-e063-6294a90ac37c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lidocaine Hydrochloride
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Water-Jel Technologies
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-04-17
- Substance
- LIDOCAINE HYDROCHLORIDE
- Active strength
- 2 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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 59898-200 | 59898-200-17 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 59898-200 | 59898-200-17 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 59898-200 | 59898-200-17 | I | Inactivated by FDA | excluded / ndc_excluded.zip | bd6a592717d7… | 303034d00443… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Burn Jel
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIDOCAINE HYDROCHLORIDE | 2 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V13007Z41A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1011852 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ff621b46-2342-41db-994d-851a09796d08 | 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 59898-200-11 | 2023-03-14 | Burn Jel |
| 59898-200-13 | 2023-03-14 | Burn Jel |
| 59898-200-15 | 2023-03-14 | Burn Jel |
| 59898-200-16 | 2023-03-14 | Burn Jel |
| 59898-200-17 | 2023-03-14 | Burn Jel |
| 59898-200-35 | 2023-03-14 | Burn Jel |
| 59898-200-49 | 2023-03-14 | Burn Jel |
| 59898-200-11 | 2022-01-28 | Burn Jel |
| 59898-200-13 | 2022-01-28 | Burn Jel |
| 59898-200-15 | 2022-01-28 | Burn Jel |
| 59898-200-16 | 2022-01-28 | Burn Jel |
| 59898-200-17 | 2022-01-28 | Burn Jel |
| 59898-200-35 | 2022-01-28 | Burn Jel |
| 59898-200-49 | 2022-01-28 | Burn Jel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59898-200-10 | Burn Jel | 59 mL in 1 BOTTLE, PLASTIC | GEL | 59 | 5 | |
| 59898-200-11 | Burn Jel | 24 in 1 CARTON | GEL | 24 | 5 | |
| 59898-200-12 | Burn Jel | 118 mL in 1 BOTTLE, PLASTIC | GEL | 118 | 5 | |
| 59898-200-13 | Burn Jel | 24 in 1 CARTON | GEL | 24 | 5 | |
| 59898-200-15 | Burn Jel | 3.5 mL in 1 PACKET | GEL | 3.5 | 5 | |
| 59898-200-15 | Burn Jel | 25 in 1 BOX | GEL | 25 | 5 | |
| 59898-200-16 | Burn Jel | 6 in 1 BOX | GEL | 6 | 5 | |
| 59898-200-16 | Burn Jel | 3.5 mL in 1 PACKET | GEL | 3.5 | 5 | |
| 59898-200-17 | Burn Jel | 3.5 mL in 1 PACKET | GEL | 3.5 | 5 | |
| 59898-200-17 | Burn Jel | 1728 in 1 CARTON | GEL | 1728 | 5 | |
| 59898-200-35 | Burn Jel | 3.5 mL in 1 PACKET | GEL | 3.5 | 5 | |
| 59898-200-49 | Burn Jel | 10 in 1 KIT | GEL | 10 | 5 | |
| 59898-200-49 | Burn Jel | 3.5 mL in 1 PACKET | GEL | 3.5 | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59898-200 | IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES] | 8 | Current NDC, Legacy NDC | 20171212_f291841e-ccbd-4f5a-b1de-4cf596a167e3.zip |
| 59898-200 | BURN JEL (LIDOCAINE HYDROCHLORIDE) GEL [WATER-JEL TECHNOLOGIES] | 5 | Current NDC, Legacy NDC, 13 package rows | 20250108_ff621b46-2342-41db-994d-851a09796d08.zip |
| 59898-200 | EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES] | 5 | Current NDC, Legacy NDC | 20171208_7e21b96a-3d89-4d1c-9ec6-0611f6c9c625.zip |
| 59898-200 | FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES] | 5 | Current NDC, Legacy NDC | 20171212_4c62196a-9f94-4823-b95f-447f012f10bf.zip |
| 59898-200 | EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES] | 3 | Current NDC, Legacy NDC | 20171212_0d2631c1-93fc-478c-afed-0f175a7e8555.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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1011852 | lidocaine HCl 2 % Topical Gel | PSN | f291841e-ccbd-4f5a-b1de-4cf596a167e3 | 8 |
| 1011852 | lidocaine hydrochloride 0.02 MG/MG Topical Gel | SCD | f291841e-ccbd-4f5a-b1de-4cf596a167e3 | 8 |
| 1011852 | lidocaine hydrochloride 2 % Topical Jelly | SY | f291841e-ccbd-4f5a-b1de-4cf596a167e3 | 8 |
| 1011852 | lidocaine HCl 2 % Topical Gel | PSN | 4c62196a-9f94-4823-b95f-447f012f10bf | 5 |
| 1011852 | lidocaine HCl 2 % Topical Gel | PSN | 7e21b96a-3d89-4d1c-9ec6-0611f6c9c625 | 5 |
| 1011852 | lidocaine HCl 2 % Topical Gel | PSN | ff621b46-2342-41db-994d-851a09796d08 | 5 |
| 1011852 | lidocaine hydrochloride 0.02 MG/MG Topical Gel | SCD | 4c62196a-9f94-4823-b95f-447f012f10bf | 5 |
| 1011852 | lidocaine hydrochloride 0.02 MG/MG Topical Gel | SCD | 7e21b96a-3d89-4d1c-9ec6-0611f6c9c625 | 5 |
| 1011852 | lidocaine hydrochloride 0.02 MG/MG Topical Gel | SCD | ff621b46-2342-41db-994d-851a09796d08 | 5 |
| 1011852 | lidocaine hydrochloride 2 % Topical Jelly | SY | 4c62196a-9f94-4823-b95f-447f012f10bf | 5 |
| 1011852 | lidocaine hydrochloride 2 % Topical Jelly | SY | 7e21b96a-3d89-4d1c-9ec6-0611f6c9c625 | 5 |
| 1011852 | lidocaine hydrochloride 2 % Topical Jelly | SY | ff621b46-2342-41db-994d-851a09796d08 | 5 |
| 1011852 | lidocaine HCl 2 % Topical Gel | PSN | 0d2631c1-93fc-478c-afed-0f175a7e8555 | 3 |
| 1011852 | lidocaine hydrochloride 0.02 MG/MG Topical Gel | SCD | 0d2631c1-93fc-478c-afed-0f175a7e8555 | 3 |
| 1011852 | lidocaine hydrochloride 2 % Topical Jelly | SY | 0d2631c1-93fc-478c-afed-0f175a7e8555 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59898-200-17 | 59898020017 | 1728 PACKET in 1 CARTON (59898-200-17) / 3.5 mL in 1 PACKET | 1728 packet | 2010-04-17 | 0000-00-00 | No | No | Current |