SODIUM PHENYLACETATE and SODIUM BENZOATE

Product NDC: 70556-100
11-digit product format: 705560100
Labeler code: 70556
Product ID: 70556-100_96dcfe63-d5ed-4ab1-810b-ebb035c58ecb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sodium phenylacetate and sodium benzoate
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Ailex Pharmaceuticals, LLC
Application: ANDA207096
Marketing category: ANDA
Marketing start: 2016-02-24
Substance: SODIUM BENZOATE; SODIUM PHENYLACETATE
Active strength: 100; 100 mg/mL; mg/mL
Pharmacologic classes: Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [EPC]
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.

Historic NDC status page 1 of 1 · 32 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70556-100-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70556-100-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70556-100-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70556-100-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70556-100-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70556-100-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70556-100-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70556-100-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70556-100-50	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70556-100-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70556-100-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70556-100-50	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70556-100-50	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70556-100-50	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70556-100-50	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70556-100-50	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	SODIUM BENZOATE; SODIUM PHENYLACETATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207096-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP	RS	2016-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207096-001	SODIUM PHENYLACETATE AND SODIUM BENZOATE	10%;10% (5GM/50ML;5GM/50ML)	SOLUTION / INTRAVENOUS	AP		2016-02-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207096-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207096-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207096-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207096-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207096-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207096-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207096-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207096-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207096-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207096-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207096-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207096-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207096-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207096-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207096-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207096-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207096-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207096-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207096-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207096-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207096-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207096-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207096-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207096-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207096-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207096-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207096-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207096-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207096-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207096-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207096-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207096-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207096-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207096-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207096-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207096-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207096-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207096-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207096-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207096-001	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: SODIUM PHENYLACETATE and SODIUM BENZOATE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM PHENYLACETATE	100 mg/mL
SODIUM BENZOATE	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
48N6U1781G	Internal UNII lookup
OJ245FE5EU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
984118	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
329655ae-c3c0-46b2-a925-e49777f2076b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70556-100-50	2025-03-30	C162847	48780-1	d6a99b39-b5db-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use SODIUM PHENYLACETATE and SODIUM BENZOATE INJECTION, 10%/10% safely and effectively. See full prescribing information for SODIUM PHENYLACETATE and SODIUM BENZOATE INJECTION, 10%/10%. SODIUM PHENYLACETATE and SODIUM BENZOATE Injection, for intravenous use Initial U.S. Approval: 1987
70556-100-50	2022-01-28	C162847	48780-1	d6a99b39-b5db-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use SODIUM PHENYLACETATE and SODIUM BENZOATE INJECTION, 10%/10% safely and effectively. See full prescribing information for SODIUM PHENYLACETATE and SODIUM BENZOATE INJECTION, 10%/10%. SODIUM PHENYLACETATE and SODIUM BENZOATE Injection, for intravenous use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70556-100-50	SODIUM PHENYLACETATE and SODIUM BENZOATE	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1		4
70556-100-50	SODIUM PHENYLACETATE and SODIUM BENZOATE	50 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	50		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70556-100	SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, SOLUTION, CONCENTRATE [AILEX PHARMACEUTICALS, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20250402_329655ae-c3c0-46b2-a925-e49777f2076b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM PHENYLACETATE and SODIUM BENZOATE	SODIUM PHENYLACETATE AND SODIUM BENZOATE	Omnivium Pharmaceuticals LLC	8fafc39b-69db-40f3-8a09-ee859e8cef19	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207096 application number: ANDA207096
SODIUM PHENYLACETATE and SODIUM BENZOATE	SODIUM PHENYLACETATE AND SODIUM BENZOATE	Ailex Pharmaceuticals, LLC	329655ae-c3c0-46b2-a925-e49777f2076b	2025-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207096 application number: ANDA207096 ndc (product): 70556-100
SODIUM PHENYLACETATE and SODIUM BENZOATE	SODIUM PHENYLACETATE AND SODIUM BENZOATE	Omnivium Pharmaceuticals LLC	9067c301-74f9-457a-9b0f-b7e9b06a3508	2025-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207096 application number: ANDA207096

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OJ245FE5EU	SODIUM BENZOATE	532-32-1	SODIUM BENZOATE
48N6U1781G	SODIUM PHENYLACETATE	114-70-5	SODIUM PHENYLACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
984118	sodium benzoate 10 % / sodium phenylacetate 10 % in 50 ML Injection	PSN	329655ae-c3c0-46b2-a925-e49777f2076b	4
984118	50 ML sodium benzoate 100 MG/ML / sodium phenylacetate 100 MG/ML Injection	SCD	329655ae-c3c0-46b2-a925-e49777f2076b	4
984118	sodium benzoate 10 % / sodium phenylacetate 10 % per 50 ML Injection	SY	329655ae-c3c0-46b2-a925-e49777f2076b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70556-100-50	70556010050	1 VIAL, SINGLE-DOSE in 1 CARTON (70556-100-50) / 50 mL in 1 VIAL, SINGLE-DOSE	2016-02-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SODIUM PHENYLACETATE and SODIUM BENZOATE	Ailex Pharmaceuticals, LLC	2025-03-30	HUMAN PRESCRIPTION DRUG LABEL	4