Dehydrated Alcohol

Product NDC: 54288-144
11-digit product format: 542880144
Labeler code: 54288
Product ID: 54288-144_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: 2025-04-01
Substance: ALCOHOL
Active strength: 1 mL/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
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N207987-001	ABLYSINOL	DEHYDRATED ALCOHOL	99% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21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#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
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UTC	2026-02	N207987-001	ABLYSINOL	99% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`011fe1cb6892…`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of this ZIP	2025-12	N207987-001	ABLYSINOL	99% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRA-ARTERIAL		RLD	2018-06-21	`31067a03dcf5…`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 table
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#

Exclusivity history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
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 table
Ingredient	Strength
ALCOHOL	1 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2048979	Internal RxNorm lookup
2048982	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314b1dab-8f4f-49ae-a105-f974842818b8	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54288-144-01	Dehydrated Alcohol	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5		12
54288-144-10	Dehydrated Alcohol	10 in 1 CARTON	INJECTION, SOLUTION	10		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54288-144-01	ML - Milliliter	54288-144	3cd4cdc0-08b8-4626-83c8-6d21d3167de7	1	2025-06-13
54288-144-10	ML - Milliliter	54288-144	893d1374-0435-4d57-8479-d50d083e2c90	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54288-144	DEHYDRATED ALCOHOL (ALCOHOL) INJECTION, SOLUTION [BPI LABS, LLC]	10	Current NDC, 2 package rows	20250402_314b1dab-8f4f-49ae-a105-f974842818b8.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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 207987 application number: NDA207987 ndc (product): 54288-144
Dehydrated Alcohol	ALCOHOL	Ajenat Pharmaceuticals LLC	636d6421-cadf-42b3-a431-ba40c06e36d2	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207987 application number: NDA207987

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
54288-144-01	54288014401	5 mL in 1 VIAL, SINGLE-DOSE	5 ml				Historical
54288-144-10	54288014410	10 VIAL, SINGLE-DOSE in 1 CARTON (54288-144-10) / 5 mL in 1 VIAL, SINGLE-DOSE (54288-144-01)		2025-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dehydrated Alcohol	BPI Labs, LLC \| Sintetica SA \| BPI Labs LLC	2026-01-05	HUMAN PRESCRIPTION DRUG LABEL	12