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 | 2026-10-16 | |
| excluded package | package | 0869-0804 | 0869-0804-45 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 0869-0804 | 0869-0804-72 | D | Discontinued by firm | 2026-10-16 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| AshleyBelle Moisturizing Hand Sanitizer Soft Berry | ETHYL ALCOHOL 70% V/V | MY IMPORTS USA LLC | 421ce569-f2d3-c1e0-e063-6294a90a822f | 2025-10-26 | Warnings | M003 |
| JOLLY RANCHER HAND SANITIZER BLUE RASPBERRY | ALCOHOL ANTISEPTIC | Kingkey MBC Life Technology Group Co.,Ltd | 42d1f66d-45f6-bb9a-e063-6394a90a06aa | 2025-10-26 | Warnings | M003 |
| Alcohol Wipe | ISOPROPYL ALCOHOL | Cardinal Health | c95bfab6-bab4-79f3-e053-2995a90a8091 | 2025-10-23 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Phoenix Healthcare Solutions LLC | 3a6e97d7-7eea-f7ca-e063-6394a90a4ecd | 2025-10-23 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Phoenix Healthcare Solutions LLC | 3a6cabf7-9310-cba5-e063-6394a90a3f91 | 2025-10-23 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Phoenix Healthcare Solutions LLC | 39529f87-ed4e-52b8-e063-6394a90af879 | 2025-10-23 | Warnings | M003 |
| CareTouch | ETHYL ALCOHOL | Phoenix Healthcare Solutions LLC | f0b55f6c-4afd-2154-e053-2995a90afcfa | 2025-10-23 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Phoenix Healthcare Solutions LLC | e8cdf841-cf56-26cc-e053-2995a90aab51 | 2025-10-23 | Warnings | M003 |
| Povidone Iodine Prep | POVIDONE IODINE | PHOENIX HEALTHCARE SOLUTIONS, LLC | c17603f2-3548-4225-b611-216c2763e51f | 2025-10-23 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Phoenix Healthcare Solutions LLC | c601d9ea-25ab-cd1d-e053-2995a90ae252 | 2025-10-23 | Warnings | M003 |
| Hand Sanitizer | ALCOHOL | Cardinal Health | cc0a6e1e-ec95-cb48-e053-2a95a90ac0ce | 2025-10-23 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Phoenix Healthcare Solutions, LLC | d07d103d-420b-5307-e053-2995a90a14f5 | 2025-10-23 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Htl-Strefa, Inc. | d72ddf5a-72e7-c37d-e053-2995a90ad48b | 2025-10-23 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Phoenix Healthcare Solutions LLC | c92524fd-8b91-592d-e053-2a95a90a88c6 | 2025-10-23 | Warnings | M003 |
| Alcohol Prep | ISOPROPYL ALCOHOL | Cardinal Health | 89852887-ae62-4277-b615-75663afb5436 | 2025-10-23 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Henry Schein, Inc. | b9826baa-b976-14c6-e053-2995a90a7d09 | 2025-10-23 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Phoenix Healthcare Solutions LLC | c9261c7f-9f8f-6476-e053-2a95a90a0e93 | 2025-10-23 | Warnings | M003 |
| Alcohol Prep Pad | ISOPROPYL ALCOHOL | Rugby Laboratories | ea28b27a-456e-4042-b769-f06072759933 | 2025-10-23 | Warnings | M003 |
| School Health Sterile Alcohol Prep Pad | ISOPROPYL ALCOHOL | School Health Corporation | 718640e1-826b-4b65-a021-3f82cd4c983a | 2025-10-23 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | Henry Schein, Inc. | 215fa8ac-c9b6-42b6-ae9d-a08d7ff0900f | 2025-10-23 | Warnings | M003 |
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 |