Isopropyl Alcohol
- Product NDC
- 0869-0804
- 11-digit product format
- 008690804
- Labeler code
- 0869
- Product ID
- 0869-0804_5b8753f2-6a2c-2918-e063-6394a90af2b8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Isopropyl alcohol
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Vi-Jon, LLC
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1989-07-15
- Substance
- ISOPROPYL ALCOHOL
- Active strength
- 91 mL/100mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 package | package | 0869-0804 | 0869-0804-08 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0869-0804 | 0869-0804-45 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0869-0804 | 0869-0804-72 | D | Discontinued by firm | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0869-0804-45 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0869-0804-08 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0869-0804-72 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0869-0804-45 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0869-0804-08 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0869-0804-72 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0869-0804-08 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0869-0804-72 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0869-0804-45 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0869-0804-08 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0869-0804-72 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0869-0804-45 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0869-0804-08 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0869-0804-72 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0869-0804-45 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0869-0804-08 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0869-0804-72 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0869-0804-45 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0869-0804-08 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0869-0804-72 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0869-0804-45 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0869-0804-08 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0869-0804-72 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0869-0804-45 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0869-0804-08 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0869-0804-72 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0869-0804-45 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0869-0804-08 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0869-0804-72 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0869-0804-45 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0869-0804-08 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0869-0804-72 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0869-0804-45 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0869-0804-08 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0869-0804-72 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0869-0804-45 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 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 | 0869-0804-43 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 0869-0804-45 | 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 | 0869-0804-45 | 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 | 0869-0804-43 | 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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ISOPROPYL ALCOHOL | 91 mL/100mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 0869-0804-43 | 2020-09-16 | Swan 804.003/804AA 91% Isopropyl Alcohol |
| 0869-0804-43 | 2020-09-16 | Swan 804.003/804AA 91% Isopropyl Alcohol |
| 0869-0804-45 | 2020-09-16 | Swan 804.003/804AA 91% Isopropyl Alcohol |
| 0869-0804-45 | 2020-09-16 | Swan 804.003/804AA 91% Isopropyl Alcohol |
| 0869-0804-43 | 2020-01-31 | Swan 804.003/804AA 91% Isopropyl Alcohol |
| 0869-0804-43 | 2020-01-31 | Swan 804.003/804AA 91% Isopropyl Alcohol |
| 0869-0804-45 | 2020-01-31 | Swan 804.003/804AA 91% Isopropyl Alcohol |
| 0869-0804-45 | 2020-01-31 | Swan 804.003/804AA 91% Isopropyl Alcohol |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0869-0804-08 | Isopropyl Alcohol | 3785 mL in 1 BOTTLE, PLASTIC | LIQUID | 3785 | 16 | |
| 0869-0804-43 | Isopropyl Alcohol | 473 mL in 1 BOTTLE, PLASTIC | LIQUID | 473 | 16 | |
| 0869-0804-45 | Isopropyl Alcohol | 946 mL in 1 BOTTLE, PLASTIC | LIQUID | 946 | 16 | |
| 0869-0804-72 | Isopropyl Alcohol | 295 mL in 1 BOTTLE, SPRAY | LIQUID | 295 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0869-0804-43 | ML - Milliliter | 0869-0804 | 4a9f248a-f231-4475-bb29-c1e00cef24f6 | 1 | 2024-04-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ISOPROPYL ALCOHOL | ACTIVE INGREDIENT | ND2M416302 | ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [VI-JON, INC] | 1 | |
| ISOPROPYL ALCOHOL | ACTIVE MOIETY | ND2M416302 | ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [VI-JON, INC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [VI-JON, INC] | 1 |
DailyMed Dashboard NDC Coverage#
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 582901 | isopropyl alcohol 91 % Topical Solution | PSN | 4df6e896-c3f7-4505-9814-9b791552b627 | 16 |
| 582901 | isopropyl alcohol 0.91 ML/ML Topical Solution | SCD | 4df6e896-c3f7-4505-9814-9b791552b627 | 16 |
| 582901 | isopropyl alcohol 91 % Topical Solution | SY | 4df6e896-c3f7-4505-9814-9b791552b627 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0869-0804-08 | 00869080408 | 3785 mL in 1 BOTTLE, PLASTIC | 3785 ml | Historical | ||||
| 0869-0804-43 | 00869080443 | 473 mL in 1 BOTTLE, PLASTIC (0869-0804-43) | 473 ml | 1989-07-15 | 0000-00-00 | No | No | Current |
| 0869-0804-45 | 00869080445 | .946 L in 1 BOTTLE, PLASTIC (0869-0804-45) | 1989-07-15 | 0000-00-00 | No | No | Current | |
| 0869-0804-72 | 00869080472 | .295 L in 1 BOTTLE, SPRAY (0869-0804-72) | 1989-07-15 | 0000-00-00 | No | No | Current |