Dehydrated Alcohol
- Product NDC
- 54288-105
- Requested package NDC
- 54288-105-15
- 11-digit product format
- 542880105
- Labeler code
- 54288
- Product ID
- 54288-105_3f7c9eef-80cc-48f3-a96f-faa55e77ef87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alcohol
- Dosage form
- INJECTION, SOLUTION
- Route
- PERCUTANEOUS
- Labeler
- BPI Labs, LLC
- Application
- NDA207987
- Marketing category
- NDA
- Marketing start
- 2018-10-24
- Substance
- ALCOHOL
- Active strength
- 1 mL/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 54288-105 | 54288-105-15 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N207987-001 | ABLYSINOL | DEHYDRATED ALCOHOL | 99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | |
| N207987-002 | ABLYSINOL | DEHYDRATED ALCOHOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | AP | RLD, RS | 2018-06-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N207987-002 | AP |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N207987-001 | ABLYSINOL | 99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | AP | RLD, RS | 2018-06-21 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207987-001 | ABLYSINOL | 99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | AP | RLD, RS | 2018-06-21 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N207987-001 | ABLYSINOL | 99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | AP | RLD, RS | 2018-06-21 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N207987-001 | ABLYSINOL | 99% (1ML) | SOLUTION / INTRA-ARTERIAL | RLD | 2018-06-21 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N207987-002 | ABLYSINOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | RLD, RS | 2018-06-21 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N207987-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207987-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N207987-002 | AP | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N207987-002 | AP | 1 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207987-001 | ODE-192 | 2025-06-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207987-002 | ODE-192 | 2025-06-21 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N207987-001 | ODE-192 | 2025-06-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N207987-002 | ODE-192 | 2025-06-21 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207987-001 | ODE-192 | 2025-06-21 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207987-002 | ODE-192 | 2025-06-21 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207987-001 | ODE-192 | 2025-06-21 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207987-002 | ODE-192 | 2025-06-21 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207987-001 | ODE-192 | 2025-06-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207987-002 | ODE-192 | 2025-06-21 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207987-001 | ODE-192 | 2025-06-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207987-002 | ODE-192 | 2025-06-21 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207987-001 | ODE-192 | 2025-06-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207987-002 | ODE-192 | 2025-06-21 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207987-001 | ODE-192 | 2025-06-21 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207987-002 | ODE-192 | 2025-06-21 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N207987-001 | ODE-192 | 2025-06-21 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N207987-002 | ODE-192 | 2025-06-21 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N207987-001 | ODE-192 | 2025-06-21 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N207987-002 | ODE-192 | 2025-06-21 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207987-001 | ODE-192 | 2025-06-21 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207987-002 | ODE-192 | 2025-06-21 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207987-001 | ODE-192 | 2025-06-21 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207987-002 | ODE-192 | 2025-06-21 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N207987-001 | ODE-192 | 2025-06-21 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N207987-002 | ODE-192 | 2025-06-21 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207987-001 | ODE-192 | 2025-06-21 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207987-002 | ODE-192 | 2025-06-21 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N207987-001 | ODE-192 | 2025-06-21 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N207987-002 | ODE-192 | 2025-06-21 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N207987-001 | ODE-192 | 2025-06-21 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N207987-002 | ODE-192 | 2025-06-21 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N207987-001 | ODE-192 | 2025-06-21 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N207987-002 | ODE-192 | 2025-06-21 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N207987-001 | ODE-192 | 2025-06-21 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N207987-002 | ODE-192 | 2025-06-21 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N207987-001 | ODE-192 | 2025-06-21 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N207987-002 | ODE-192 | 2025-06-21 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N207987-001 | ODE-192 | 2025-06-21 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N207987-002 | ODE-192 | 2025-06-21 | 87673890dc5c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dehydrated Alcohol
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALCOHOL | 1 mL/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3K9958V90M | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 314b1dab-8f4f-49ae-a105-f974842818b8 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54288-105-01 | Dehydrated Alcohol | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | 12 | |
| 54288-105-02 | Dehydrated Alcohol | 5 mL in 1 AMPULE | INJECTION, SOLUTION | 5 | 12 | |
| 54288-105-10 | Dehydrated Alcohol | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 12 | |
| 54288-105-15 | Dehydrated Alcohol | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54288-105-02 | ML - Milliliter | 54288-105 | a37caae1-997e-40ce-b94a-9dcccb7d5b6d | 1 | 2019-03-12 |
| 54288-105-15 | ML - Milliliter | 54288-105 | 78c8f687-b3ae-4eb7-8a44-a1bb1842eec7 | 1 | 2019-03-12 |
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 |
|---|---|---|---|---|---|---|
| Dehydrated Alcohol | ALCOHOL | BPI Labs, LLC | 314b1dab-8f4f-49ae-a105-f974842818b8 | 2026-01-05 | Warnings, Adverse reactions | 207987 NDA207987 54288-105-15 54288-105 54288010515 |
| Dehydrated Alcohol | ALCOHOL | Ajenat Pharmaceuticals LLC | 636d6421-cadf-42b3-a431-ba40c06e36d2 | 2025-12-29 | Warnings, Adverse reactions | 207987 NDA207987 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2048979 | ethanol 99 % in 1 ML Injection | PSN | 314b1dab-8f4f-49ae-a105-f974842818b8 | 12 |
| 2048982 | ethanol 99 % in 5 ML Injection | PSN | 314b1dab-8f4f-49ae-a105-f974842818b8 | 12 |
| 2048979 | 1 ML ethanol 0.99 ML/ML Injection | SCD | 314b1dab-8f4f-49ae-a105-f974842818b8 | 12 |
| 2048982 | 5 ML ethanol 0.99 ML/ML Injection | SCD | 314b1dab-8f4f-49ae-a105-f974842818b8 | 12 |
| 2048979 | ethanol 99 % per 1 ML Injection | SY | 314b1dab-8f4f-49ae-a105-f974842818b8 | 12 |
| 2048982 | ethanol 99 % per 5 ML Injection | SY | 314b1dab-8f4f-49ae-a105-f974842818b8 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54288-105-15 | 54288010515 | 10 AMPULE in 1 CARTON (54288-105-15) / 5 mL in 1 AMPULE (54288-105-02) | 10 ampule | 2018-10-24 | 0000-00-00 | No | No | Current |