Alocane Emergency Burn
- Product NDC
- 68229-201
- 11-digit product format
- 682290201
- Labeler code
- 68229
- Product ID
- 68229-201_ed344191-2420-26fb-e053-2a95a90a0d7b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lidocaine Hydrochloride
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Quest Products, LLC.
- Application
- part348
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2019-03-01
- Marketing end
- 0000-00-00
- Substance
- LIDOCAINE HYDROCHLORIDE
- Active strength
- 4 g/100mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 product | product | 68229-201 | D | Discontinued by firm | 2026-11-10 | ||
| excluded package | package | 68229-201 | 68229-201-02 | D | Discontinued by firm | 2026-11-10 | |
| excluded package | package | 68229-201 | 68229-201-03 | D | Discontinued by firm | 2026-11-10 | |
| excluded package | package | 68229-201 | 68229-201-05 | D | Discontinued by firm | 2026-11-10 | |
| excluded package | package | 68229-201 | 68229-201-07 | D | Discontinued by firm | 2026-11-10 | |
| excluded package | package | 68229-201 | 68229-201-08 | D | Discontinued by firm | 2026-11-10 | |
| excluded package | package | 68229-201 | 68229-201-10 | D | Discontinued by firm | 2026-11-10 | |
| excluded package | package | 68229-201 | 68229-201-11 | D | Discontinued by firm | 2026-11-10 | |
| excluded package | package | 68229-201 | 68229-201-12 | D | Discontinued by firm | 2026-11-10 | |
| excluded package | package | 68229-201 | 68229-201-13 | D | Discontinued by firm | 2026-11-10 | |
| excluded package | package | 68229-201 | 68229-201-14 | D | Discontinued by firm | 2026-11-10 | |
| excluded package | package | 68229-201 | 68229-201-16 | D | Discontinued by firm | 2026-11-10 | |
| excluded package | package | 68229-201 | 68229-201-18 | D | Discontinued by firm | 2026-11-10 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 68229-201-12 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 68229-201-14 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 68229-201-12 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 68229-201-14 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 68229-201-12 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 68229-201-14 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 68229-201-12 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 68229-201-14 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 68229-201-12 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 68229-201-14 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 68229-201-12 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 68229-201-14 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 68229-201-12 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 68229-201-14 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 68229-201-12 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 68229-201-14 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 68229-201-12 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 68229-201-14 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 68229-201-12 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 68229-201-12 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 68229-201-12 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|---|---|---|---|---|---|
| 68229-201-01 | Alocane Emergency Burn | 110 mL in 1 TUBE | GEL | 110 | 14 | |
| 68229-201-02 | Alocane Emergency Burn | 1 in 1 CARTON | GEL | 1 | 14 | |
| 68229-201-03 | Alocane Emergency Burn | 110 mL in 1 BOTTLE, SPRAY | GEL | 110 | 14 | |
| 68229-201-04 | Alocane Emergency Burn | 3.4 mL in 1 PACKET | GEL | 3.4 | 14 | |
| 68229-201-05 | Alocane Emergency Burn | 24 in 1 CARTON | GEL | 24 | 14 | |
| 68229-201-06 | Alocane Emergency Burn | 3.4 mL in 1 PACKET | GEL | 3.4 | 14 | |
| 68229-201-07 | Alocane Emergency Burn | 45 in 1 CARTON | GEL | 45 | 14 | |
| 68229-201-08 | Alocane Emergency Burn | 103.507 mL in 1 BOTTLE, SPRAY | GEL | 103.507 | 14 | |
| 68229-201-09 | Alocane Emergency Burn | 118.294 mL in 1 TUBE | GEL | 118.294 | 14 | |
| 68229-201-10 | Alocane Emergency Burn | 1 in 1 CARTON | GEL | 1 | 14 | |
| 68229-201-11 | Alocane Emergency Burn | 133.081 mL in 1 BOTTLE, SPRAY | GEL | 133.081 | 14 | |
| 68229-201-12 | Alocane Emergency Burn | 1 in 1 KIT | GEL | 1 | 14 | |
| 68229-201-13 | Alocane Emergency Burn | 1 in 1 CARTON | GEL | 1 | 14 | |
| 68229-201-14 | Alocane Emergency Burn | 946 mL in 1 BOTTLE, PUMP | GEL | 946 | 14 | |
| 68229-201-15 | Alocane Emergency Burn | 800 mL in 1 BAG | GEL | 800 | 14 | |
| 68229-201-16 | Alocane Emergency Burn | 124 mL in 1 BOTTLE, SPRAY | GEL | 124 | 14 | |
| 68229-201-17 | Alocane Emergency Burn | 22 mL in 1 TUBE | GEL | 22 | 14 | |
| 68229-201-18 | Alocane Emergency Burn | 1 in 1 CARTON | GEL | 1 | 14 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1875237 | Alocane 4 % Topical Gel | PSN | 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 | 14 |
| 1010077 | lidocaine HCl 4 % Topical Gel | PSN | 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 | 14 |
| 1875237 | lidocaine hydrochloride 0.04 MG/MG Topical Gel [Alocane] | SBD | 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 | 14 |
| 1010077 | lidocaine hydrochloride 0.04 MG/MG Topical Gel | SCD | 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 | 14 |
| 1875237 | Alocane 0.04 MG/MG Topical Gel | SY | 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 | 14 |
| 1875237 | Alocane 4 % Topical Gel | SY | 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 | 14 |
| 1010077 | lidocaine hydrochloride 4 % Topical Gel | SY | 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68229-201-01 | 68229020101 | 110 mL in 1 TUBE | 110 ml | Historical | ||||
| 68229-201-02 | 68229020102 | 1 TUBE in 1 CARTON (68229-201-02) > 110 mL in 1 TUBE (68229-201-01) | 1 tube | 2019-03-01 | 0000-00-00 | No | No | Current |
| 68229-201-03 | 68229020103 | 110 mL in 1 BOTTLE, SPRAY (68229-201-03) | 110 ml | 2020-03-01 | 0000-00-00 | No | No | Current |
| 68229-201-04 | 68229020104 | 3.4 mL in 1 PACKET | 3.4 ml | Historical | ||||
| 68229-201-05 | 68229020105 | 24 PACKET in 1 CARTON (68229-201-05) > 3.4 mL in 1 PACKET (68229-201-04) | 24 packet | 2020-03-01 | 0000-00-00 | No | No | Current |
| 68229-201-06 | 68229020106 | 3.4 mL in 1 PACKET | 3.4 ml | Historical | ||||
| 68229-201-07 | 68229020107 | 45 PACKET in 1 CARTON (68229-201-07) > 3.4 mL in 1 PACKET (68229-201-06) | 45 packet | 2020-03-01 | 0000-00-00 | No | No | Current |
| 68229-201-08 | 68229020108 | 103.507 mL in 1 BOTTLE, SPRAY (68229-201-08) | 103.507 ml | 2020-03-01 | 0000-00-00 | No | No | Current |
| 68229-201-09 | 68229020109 | 118.294 mL in 1 TUBE | 118.294 ml | Historical | ||||
| 68229-201-10 | 68229020110 | 1 TUBE in 1 CARTON (68229-201-10) > 118.294 mL in 1 TUBE (68229-201-09) | 1 tube | 2019-03-01 | 0000-00-00 | No | No | Current |
| 68229-201-11 | 68229020111 | 133.081 mL in 1 BOTTLE, SPRAY (68229-201-11) | 133.081 ml | 2020-03-01 | 0000-00-00 | No | No | Current |
| 68229-201-12 | 68229020112 | 1 BAG in 1 KIT (68229-201-12) > 800 mL in 1 BAG (68229-201-15) | 1 bag | 2019-03-01 | 0000-00-00 | No | No | Current |
| 68229-201-13 | 68229020113 | 1 BAG in 1 CARTON (68229-201-13) > 800 mL in 1 BAG (68229-201-15) | 1 bag | 2019-03-01 | 0000-00-00 | No | No | Current |
| 68229-201-14 | 68229020114 | 946 mL in 1 BOTTLE, PUMP (68229-201-14) | 946 ml | 2019-03-01 | 0000-00-00 | No | No | Current |
| 68229-201-15 | 68229020115 | 800 mL in 1 BAG | 800 ml | Historical | ||||
| 68229-201-16 | 68229020116 | 124 mL in 1 BOTTLE, SPRAY (68229-201-16) | 124 ml | 2022-11-11 | 0000-00-00 | No | No | Current |
| 68229-201-17 | 68229020117 | 22 mL in 1 TUBE | 22 ml | Historical | ||||
| 68229-201-18 | 68229020118 | 1 TUBE in 1 CARTON (68229-201-18) > 22 mL in 1 TUBE (68229-201-17) | 1 tube | 2021-12-09 | 0000-00-00 | No | No | Current |