Isopropyl Alcohol
- Product NDC
- 61010-5500
- 11-digit product format
- 610105500
- Labeler code
- 61010
- Product ID
- 61010-5500_3bdedf7b-d99b-fa9e-e063-6294a90aa631
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Isopropyl Alcohol
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- Safetec of America, Inc.
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-02-16
- Substance
- ISOPROPYL ALCOHOL
- Active strength
- 70 mL/100mL
- 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 | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 61010-5500-2 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 61010-5500-2 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isopropyl Alcohol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ISOPROPYL ALCOHOL | 70 mL/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| ND2M416302 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1014638 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 89310a64-c4cc-46c6-8294-c4d28cd88118 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-08-08 | Isopropyl alcohol, 70% 2oz. Bottle |
| 2022-01-28 | Isopropyl alcohol, 70% 2oz. Bottle |
| 2021-02-04 | Isopropyl alcohol, 70% 2oz. Bottle |
| 2020-01-31 | Isopropyl alcohol, 70% 2oz. Bottle |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61010-5500-2 | Isopropyl Alcohol | 59.1 mL in 1 BOTTLE, SPRAY | SPRAY | 59.1 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| isopropyl alcohol | ACTIVE INGREDIENT | ND2M416302 | ISOPROPYL ALCOHOL SPRAY [SAFETEC OF AMERICA, INC.] | 1 | |
| isopropyl alcohol | ACTIVE MOIETY | ND2M416302 | ISOPROPYL ALCOHOL SPRAY [SAFETEC OF AMERICA, INC.] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | ISOPROPYL ALCOHOL SPRAY [SAFETEC OF AMERICA, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61010-5500 | ISOPROPYL ALCOHOL SPRAY [SAFETEC OF AMERICA, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20210204_89310a64-c4cc-46c6-8294-c4d28cd88118.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Xpect First Aid Cream | BENZALKONIUM CHLORIDE, LIDOCAINE HCL | Cintas Corporation | f7112e5d-c8c4-42ad-8a65-24bfc32d4aea | 2025-09-30 | Warnings | M003 |
| Xpect Antiseptic Wipes | ANTISEPTIC CLEANSER | Cintas Corporation | 8f1fd933-965e-42ec-ab96-47cfe780f963 | 2025-09-29 | Warnings | M003 |
| EVR Alcohol Prep Pads | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd. | 3ffba233-6106-f633-e063-6394a90a96fe | 2025-09-29 | Warnings | M003 |
| ProHeal Alcohol Prep Pad | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd. | 3ffc0619-eb13-77af-e063-6394a90a2fd9 | 2025-09-29 | Warnings | M003 |
| ProHeal BZK Antiseptic Towelettes | BENZALKONIUM CHLORIDE | Changzhou Maokang Medical Products Co., Ltd. | 3ffc3f34-086d-1d18-e063-6294a90a71bb | 2025-09-29 | Warnings | M003 |
| First Aid Direct Alcohol Wipe | ISOPROPYL ALCOHOL | Cintas Corporation | 6a71449e-9a97-4923-8ec1-b1deb45b5746 | 2025-09-29 | Warnings | M003 |
| Northside Hospital Mothers Kit, Grey Backpack | ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE | ASP Global, LLc | 0868060e-d593-4cb2-b3d2-6c59d1ae5efc | 2025-09-29 | Warnings | M003 |
| First Aid Direct Antiseptic Wipe | BENZALKONIUM CHLORIDE | Cintas Corporation | a23f3685-7213-4cc0-97b2-588fb1224792 | 2025-09-29 | Warnings | M003 |
| Xpect Alcohol Wipes | ALCOHOL WIPES | Cintas Corporation | 51185b9a-ed6b-4a49-b524-b3ff0d5c6290 | 2025-09-29 | Warnings | M003 |
| Super-Stop BloodClotter | BLOOD CLOTTER | Cintas Corp | d910ee9b-187d-49a9-ab96-281730db2575 | 2025-09-26 | Warnings | M003 |
| Hand Sanitizer plus Holder | BENZALKONIUM CHLORIDE | Aocai Biotechnology Huizhou Co Ltd | 3fa738ce-0a04-fa11-e063-6294a90aba88 | 2025-09-25 | Warnings | M003 |
| Fresh Feels Hand Sanitizer | FRESH FEELS HAND SANITIZER | ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD | 3e36e2c4-fe4d-d517-e063-6394a90ac4be | 2025-09-25 | Warnings | M003 |
| 3 Hydrogen Peroxide | HYDROGEN PEROXIDE | Jell Pharmaceuticals Pvt Ltd. | ddc59e50-083a-6cd9-e053-2995a90ad401 | 2025-09-24 | Warnings | M003 |
| Hand Sanitizer(CHERRY) | HAND SANITIZER(CHERRY) | ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD | 3d6cc842-8b54-9a27-e063-6294a90a1dd5 | 2025-09-24 | Warnings | M003 |
| Hand Sanitizer(PEACH) | HAND SANITIZER(PEACH) | ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD | 3d6bf6be-5328-8151-e063-6294a90a8211 | 2025-09-24 | Warnings | M003 |
| Hand Sanitizer(COCONUT) | HAND SANITIZER(COCONUT) | ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD | 3d6ca090-98d9-4650-e063-6294a90a35c0 | 2025-09-24 | Warnings | M003 |
| Hand Sanitizer(MANGO) | HAND SANITIZER(MANGO) | ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD | 3d6c79b9-d4b1-bbaf-e063-6394a90a1100 | 2025-09-24 | Warnings | M003 |
| Hand Sanitizer Matcha Mood | ALCOHOL | Scent Theory Products LLC | 3f8fc09d-863d-0c13-e063-6394a90a4968 | 2025-09-24 | Warnings | M003 |
| Hand Sanitizer Ocean Mist | ALCOHOL | Scent Theory Products LLC | 3f8fd236-e413-30f8-e063-6394a90a4c96 | 2025-09-24 | Warnings | M003 |
| Hand Sanitizer Sunrise Citrus | ALCOHOL | Scent Theory Products LLC | 3f8fd236-e415-30f8-e063-6394a90a4c96 | 2025-09-24 | Warnings | M003 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014638 | isopropyl alcohol 70 % Topical Spray | PSN | 89310a64-c4cc-46c6-8294-c4d28cd88118 | 4 |
| 1014638 | isopropyl alcohol 0.7 ML/ML Topical Spray | SCD | 89310a64-c4cc-46c6-8294-c4d28cd88118 | 4 |
| 1014638 | isopropyl alcohol 70 % Topical Spray | SY | 89310a64-c4cc-46c6-8294-c4d28cd88118 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61010-5500-2 | 61010550002 | 59.1 mL in 1 BOTTLE, SPRAY (61010-5500-2) | 59.1 ml | 2012-02-16 | 0000-00-00 | No | No | Current |