Prosanca
- Product NDC
- 77838-116
- 11-digit product format
- 778380116
- Labeler code
- 77838
- Product ID
- 77838-116_d3b31d41-fec4-52a6-e053-2995a90ad3fd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- 70% Ethanol
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- proem group
- Application
- part333A
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2021-01-15
- Marketing end
- 0000-00-00
- Substance
- ALCOHOL
- Active strength
- 70 mL/100mL
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 77838-116 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 77838-116 | 77838-116-15 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 77838-116 | 77838-116-16 | 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 | 77838-116-15 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 77838-116-16 | 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 | 77838-116-15 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 77838-116-16 | 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 | 77838-116-15 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 77838-116-16 | 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 | 77838-116-15 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 77838-116-16 | 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 | 77838-116-15 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 77838-116-16 | 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 | 77838-116-15 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 77838-116-16 | 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 | 77838-116-15 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 77838-116-16 | 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 | 77838-116-15 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 77838-116-16 | 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 | 77838-116-15 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 77838-116-16 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 77838-116-15 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 77838-116-16 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 77838-116-15 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 77838-116-16 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 77838-116-15 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 77838-116-16 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 77838-116-15 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 77838-116-16 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 77838-116-15 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 77838-116-16 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 77838-116-15 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 77838-116-16 | 1332a3947898… | d4bfe170f9cd… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 77838-116-15 | 2023-01-30 | C162847 | 48780-1 | f386c649-aeb4-0266-e053-dadaa90a7c1a | Hand Sanitizer and Rubbing Alcohol |
| 77838-116-16 | 2023-01-30 | C162847 | 48780-1 | f386c649-aeb4-0266-e053-dadaa90a7c1a | Hand Sanitizer and Rubbing Alcohol |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77838-116-15 | Prosanca | 500 mL in 1 BOTTLE | SPRAY | 500 | 5 | |
| 77838-116-16 | Prosanca | 1000 mL in 1 BOTTLE | SPRAY | 1000 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 77838-116 | PROSANCA (ETHYL 70% ALOE VERA) GEL PROSANCA (ETHANOL ALCOHOL) GEL PROSANCA (ISOPROPYL 70% ISOPROPYL) SPRAY PROSANCA (ISOPROPYL 91% ISOPROPYL) SPRAY PROSANCA (ETHANOL 91% ETHANOL APPLICATOR) SPRAY PROSANCA (70% ETHANOL) SPRAY PROSANCA (ISOPROPYL 99% ISOPROPYL) SPRAY [PROEM GROUP] | 5 | Legacy NDC, 2 package rows | 20211222_a67e56ed-ac51-6446-e053-2995a90ac063.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 581662 | ethanol 70 % Topical Gel | PSN | a67e56ed-ac51-6446-e053-2995a90ac063 | 5 |
| 1041849 | ethanol 70 % Topical Spray | PSN | a67e56ed-ac51-6446-e053-2995a90ac063 | 5 |
| 2473848 | ethanol 91 % Topical Spray | PSN | a67e56ed-ac51-6446-e053-2995a90ac063 | 5 |
| 581662 | ethanol 0.7 ML/ML Topical Gel | SCD | a67e56ed-ac51-6446-e053-2995a90ac063 | 5 |
| 1041849 | ethanol 0.7 ML/ML Topical Spray | SCD | a67e56ed-ac51-6446-e053-2995a90ac063 | 5 |
| 2473848 | ethanol 0.91 ML/ML Topical Spray | SCD | a67e56ed-ac51-6446-e053-2995a90ac063 | 5 |
| 581662 | ethanol 70 % Topical Gel | SY | a67e56ed-ac51-6446-e053-2995a90ac063 | 5 |
| 1041849 | ethanol 70 % Topical Spray | SY | a67e56ed-ac51-6446-e053-2995a90ac063 | 5 |
| 2473848 | ethanol 91 % Topical Spray | SY | a67e56ed-ac51-6446-e053-2995a90ac063 | 5 |
| 581662 | ethyl alcohol 70 % Topical Gel | SY | a67e56ed-ac51-6446-e053-2995a90ac063 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 77838-116-15 | 77838011615 | 500 mL in 1 BOTTLE (77838-116-15) | 500 ml | 2021-01-15 | 0000-00-00 | No | No | Current |
| 77838-116-16 | 77838011616 | 1000 mL in 1 BOTTLE (77838-116-16) | 1000 ml | 2021-01-15 | 0000-00-00 | No | No | Current |