Safety First 70% Ethanol Hand Sanitizer Gel
- Product NDC
- 78346-010
- 11-digit product format
- 783460010
- Labeler code
- 78346
- Product ID
- 78346-010_e7024adf-2fbd-3e1c-e053-2a95a90af361
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- 70% Ethanol Hand Sanitizer
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Otto Solutions LLC
- Application
- part333A
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2020-11-09
- Marketing end
- 0000-00-00
- Substance
- ALCOHOL
- Active strength
- 70 mL/100mL
- 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 | 78346-010 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 78346-010 | 78346-010-01 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 78346-010 | 78346-010-02 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 78346-010 | 78346-010-03 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 78346-010 | 78346-010-04 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 78346-010 | 78346-010-05 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 78346-010 | 78346-010-06 | I | Inactivated by FDA | 2026-10-05 |
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 78346-010-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 78346-010-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 78346-010-03 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 78346-010-06 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 78346-010-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 78346-010-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 78346-010-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 78346-010-05 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 78346-010-03 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 78346-010-06 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 78346-010-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 78346-010-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 78346-010-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 78346-010-05 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 78346-010-03 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 78346-010-06 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 78346-010-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 78346-010-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 78346-010-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 78346-010-05 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 78346-010-03 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 78346-010-06 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 78346-010-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 78346-010-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 78346-010-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 78346-010-05 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 78346-010-03 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 78346-010-06 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 78346-010-04 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 78346-010-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 78346-010-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 78346-010-05 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 78346-010-03 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 78346-010-06 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 78346-010-04 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 78346-010-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 78346-010-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 78346-010-05 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 78346-010-03 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 78346-010-06 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 78346-010-04 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 78346-010-02 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 78346-010-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 78346-010-05 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 78346-010-03 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 78346-010-06 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 78346-010-04 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 78346-010-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 78346-010-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 78346-010-05 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 78346-010-03 | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78346-010-01 | Safety First 70% Ethanol Hand Sanitizer Gel | 3785 mL in 1 BOTTLE | GEL | 3785 | 14 | |
| 78346-010-02 | Safety First 70% Ethanol Hand Sanitizer Gel | 15142 mL in 1 CASE | GEL | 15142 | 14 | |
| 78346-010-03 | Safety First 70% Ethanol Hand Sanitizer Gel | 473 mL in 1 BOTTLE | GEL | 473 | 14 | |
| 78346-010-04 | Safety First 70% Ethanol Hand Sanitizer Gel | 5678 mL in 1 CASE | GEL | 5678 | 14 | |
| 78346-010-05 | Safety First 70% Ethanol Hand Sanitizer Gel | 208000 mL in 1 DRUM | GEL | 208000 | 14 | |
| 78346-010-06 | Safety First 70% Ethanol Hand Sanitizer Gel | 250000 mL in 1 DRUM | GEL | 250000 | 14 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 78346-010 | DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH ROSE (70% ETHANOL HAND SANITIZER) GEL KIRANEX 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS (70% ETHANOL HAND SANITIZER) GEL COMPASS 70% ETHANOL HAND SANITIZER GEL WITH CITRUS (70% ETHANOL HAND SANITIZER) GEL COMPASS 70% ETHANOL HAND SANITIZER GEL WITH LAVENDER (70% ETHANOL HAND SANITIZER) GEL DR LUCID 70% ETHANOL HAND SANITIZER GEL (70% ETHANOL HAND SANITIZER) GEL DR LUCID 70% ETHANOL HAND SANITIZER (70% ETHANOL HAND SANITIZER) LIQUID DR LUCID HAND SANITIZER (65% ETHANOL) GEL DR LUCID 70% IPA SANITIZER (70% ISOPROPANOL) LIQUID DR LUCID 91% IPA SANITIZER (91% ISOPROPANOL) LIQUID SAFETY FIRST 70% ETHANOL HAND SANITIZER GEL (70% ETHANOL HAND SANITIZER) GEL DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS (70% ETHANOL HAND SANITIZER) GEL DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH ROSE (70% ETHANOL HAND SANITIZER) GEL DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH EUCALYPTUS (70% ETHANOL HAND SANITIZER) GEL [OTTO SOLUTIONS LLC] | 14 | Legacy NDC, 6 package rows | 20220826_a6b82bf2-2362-38f2-e053-2995a90a31ed.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 581662 | ethanol 70 % Topical Gel | PSN | a6b82bf2-2362-38f2-e053-2995a90a31ed | 14 |
| 581662 | ethanol 0.7 ML/ML Topical Gel | SCD | a6b82bf2-2362-38f2-e053-2995a90a31ed | 14 |
| 581662 | ethanol 70 % Topical Gel | SY | a6b82bf2-2362-38f2-e053-2995a90a31ed | 14 |
| 581662 | ethyl alcohol 70 % Topical Gel | SY | a6b82bf2-2362-38f2-e053-2995a90a31ed | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 78346-010-01 | 78346001001 | 3785 mL in 1 BOTTLE (78346-010-01) | 3785 ml | 2020-11-09 | 0000-00-00 | No | No | Current |
| 78346-010-02 | 78346001002 | 15142 mL in 1 CASE (78346-010-02) | 15142 ml | 2020-11-09 | 0000-00-00 | No | No | Current |
| 78346-010-03 | 78346001003 | 473 mL in 1 BOTTLE (78346-010-03) | 473 ml | 2020-11-09 | 0000-00-00 | No | No | Current |
| 78346-010-04 | 78346001004 | 5678 mL in 1 CASE (78346-010-04) | 5678 ml | 2020-11-09 | 0000-00-00 | No | No | Current |
| 78346-010-05 | 78346001005 | 208000 mL in 1 DRUM (78346-010-05) | 208000 ml | 2020-11-17 | 0000-00-00 | No | No | Current |
| 78346-010-06 | 78346001006 | 250000 mL in 1 DRUM (78346-010-06) | 250000 ml | 2020-11-17 | 0000-00-00 | No | No | Current |