Hygenize Original Hand Sanitizer
- Product NDC
- 80808-002
- 11-digit product format
- 808080002
- Labeler code
- 80808
- Product ID
- 80808-002_b4421d7d-8613-e55f-e053-2a95a90acb4a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Alcohol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Hygenize Corp.
- Application
- part333A
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2020-10-04
- Marketing end
- 0000-00-00
- Substance
- ISOPROPYL ALCOHOL
- Active strength
- 70 mL/100mL
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 80808-002 | I | Inactivated by FDA | 2026-10-12 | ||
| excluded package | package | 80808-002 | 80808-002-14 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 80808-002 | 80808-002-18 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 80808-002 | 80808-002-19 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 80808-002 | 80808-002-26 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 80808-002 | 80808-002-92 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 80808-002 | 80808-002-93 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 80808-002 | 80808-002-98 | I | Inactivated by FDA | 2026-10-12 |
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 | 80808-002-18 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 80808-002-26 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 80808-002-14 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 80808-002-92 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 80808-002-93 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 80808-002-98 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 80808-002-19 | 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 | 80808-002-18 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 80808-002-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 80808-002-14 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 80808-002-92 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 80808-002-93 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 80808-002-98 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 80808-002-19 | 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 | 80808-002-18 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 80808-002-26 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 80808-002-14 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 80808-002-92 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 80808-002-93 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 80808-002-98 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 80808-002-19 | 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 | 80808-002-18 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 80808-002-26 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 80808-002-14 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 80808-002-92 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 80808-002-93 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 80808-002-98 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 80808-002-19 | 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 | 80808-002-18 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 80808-002-26 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 80808-002-14 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 80808-002-92 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 80808-002-93 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 80808-002-98 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 80808-002-19 | 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 | 80808-002-18 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 80808-002-26 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 80808-002-14 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 80808-002-92 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 80808-002-93 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 80808-002-98 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 80808-002-19 | 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 | 80808-002-18 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 80808-002-26 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 80808-002-14 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 80808-002-92 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 80808-002-93 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 80808-002-98 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 80808-002-19 | 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 | 80808-002-18 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 80808-002-26 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 80808-002-14 | ed331223b511… | 672a5bd82f5f… |
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 |
|---|---|---|---|---|---|---|
| 80808-002-02 | Hygenize Original Hand Sanitizer | 60 mL in 1 BOTTLE, DISPENSING | GEL | 60 | 6 | |
| 80808-002-04 | Hygenize Original Hand Sanitizer | 118 mL in 1 BOTTLE, DISPENSING | GEL | 118 | 6 | |
| 80808-002-08 | Hygenize Original Hand Sanitizer | 237 mL in 1 BOTTLE, DISPENSING | GEL | 237 | 6 | |
| 80808-002-09 | Hygenize Original Hand Sanitizer | 237 mL in 1 BOTTLE, PUMP | GEL | 237 | 6 | |
| 80808-002-14 | Hygenize Original Hand Sanitizer | 48 in 1 CARTON | GEL | 48 | 6 | |
| 80808-002-16 | Hygenize Original Hand Sanitizer | 500 mL in 1 BOTTLE, PUMP | GEL | 500 | 6 | |
| 80808-002-18 | Hygenize Original Hand Sanitizer | 48 in 1 CARTON | GEL | 48 | 6 | |
| 80808-002-19 | Hygenize Original Hand Sanitizer | 48 in 1 CARTON | GEL | 48 | 6 | |
| 80808-002-26 | Hygenize Original Hand Sanitizer | 32 in 1 CARTON | GEL | 32 | 6 | |
| 80808-002-28 | Hygenize Original Hand Sanitizer | 3785 mL in 1 BOTTLE | GEL | 3785 | 6 | |
| 80808-002-32 | Hygenize Original Hand Sanitizer | 946 mL in 1 BOTTLE, PUMP | GEL | 946 | 6 | |
| 80808-002-92 | Hygenize Original Hand Sanitizer | 48 in 1 CARTON | GEL | 48 | 6 | |
| 80808-002-93 | Hygenize Original Hand Sanitizer | 12 in 1 CARTON | GEL | 12 | 6 | |
| 80808-002-98 | Hygenize Original Hand Sanitizer | 4 in 1 CARTON | GEL | 4 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80808-002 | HYGENIZE ORIGINAL HAND SANITIZER (ISOPROPYL ALCOHOL) SPRAY HYGENIZE ORIGINAL HAND SANITIZER (ALCOHOL) GEL HYGENIZE ALCOHOL WIPES (ALCOHOL) PATCH [HYGENIZE CORP.] | 6 | Legacy NDC, 14 package rows | 20201019_b0cf6932-c303-5cf9-e053-2995a90a0c37.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1598066 | isopropyl alcohol 75 % Topical Spray | PSN | b0cf6932-c303-5cf9-e053-2995a90a0c37 | 6 |
| 1598066 | isopropyl alcohol 0.75 ML/ML Topical Spray | SCD | b0cf6932-c303-5cf9-e053-2995a90a0c37 | 6 |
| 1598066 | isopropyl alcohol 75 % Topical Spray | SY | b0cf6932-c303-5cf9-e053-2995a90a0c37 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 80808-002-02 | 80808000202 | 60 mL in 1 BOTTLE, DISPENSING | 60 ml | Historical |
| 80808-002-04 | 80808000204 | 118 mL in 1 BOTTLE, DISPENSING | 118 ml | Historical |
| 80808-002-08 | 80808000208 | 237 mL in 1 BOTTLE, DISPENSING | 237 ml | Historical |
| 80808-002-09 | 80808000209 | 237 mL in 1 BOTTLE, PUMP | 237 ml | Historical |
| 80808-002-14 | 80808000214 | 48 in 1 CARTON | Historical | |
| 80808-002-16 | 80808000216 | 500 mL in 1 BOTTLE, PUMP | 500 ml | Historical |
| 80808-002-18 | 80808000218 | 48 in 1 CARTON | Historical | |
| 80808-002-19 | 80808000219 | 48 in 1 CARTON | Historical | |
| 80808-002-26 | 80808000226 | 32 in 1 CARTON | Historical | |
| 80808-002-28 | 80808000228 | 3785 mL in 1 BOTTLE | 3785 ml | Historical |
| 80808-002-32 | 80808000232 | 946 mL in 1 BOTTLE, PUMP | 946 ml | Historical |
| 80808-002-92 | 80808000292 | 48 in 1 CARTON | Historical | |
| 80808-002-93 | 80808000293 | 12 in 1 CARTON | Historical | |
| 80808-002-98 | 80808000298 | 4 in 1 CARTON | Historical |