Natesto

Product NDC: 69654-239
11-digit product format: 696540239
Labeler code: 69654
Product ID: 69654-239_ef5a567e-c70f-4cb0-81f9-f053ebf1b26e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: testosterone
Dosage form: GEL
Route: NASAL
Labeler: Aytu BioScience, Inc.
Application: NDA205488
Marketing category: NDA
Marketing start: 2017-09-01
Marketing end: 0000-00-00
Substance: TESTOSTERONE
Active strength: 6 mg/1
Pharmacologic classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69654-239		I	Inactivated by FDA		2026-08-17
excluded package	package	69654-239	69654-239-01	I	Inactivated by FDA		2026-08-17

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 · 38 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69654-239-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69654-239-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`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	69654-239-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69654-239-01	`8dfbde2a14a4…`	`c9ff85d89658…`

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
N205488-001	NATESTO	TESTOSTERONE	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		RLD, RS	2014-05-28

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N205488-001	11090312	2034-03-17	U-1616	2021-09-10
N205488-001	11744838	2034-03-17	U-4366	2026-01-07
N205488-001	11744838	2034-03-17	U-4367	2026-01-07

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL	RLD, RS	2014-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205488-001	NATESTO	5.5MG/0.122GM ACTUATION	GEL, METERED / NASAL		2014-05-28	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205488-001	11090312	2034-03-17	U-1616		2021-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205488-001	11744838	2034-03-17	U-4366		2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205488-001	11744838	2034-03-17	U-4367		2026-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205488-001	11090312	2034-03-17	U-1616		2021-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205488-001	11744838	2034-03-17	U-4366		2026-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205488-001	11744838	2034-03-17	U-4367		2026-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205488-001	11090312	2034-03-17	U-1616		2021-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205488-001	11090312	2034-03-17	U-1616		2021-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205488-001	11090312	2034-03-17	U-1616		2021-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205488-001	11090312	2034-03-17	U-1616		2021-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205488-001	8574622	2024-02-04		Drug product	2014-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205488-001	8784869	2024-02-04		Drug product	2014-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205488-001	8784882	2024-02-04	U-1557	Drug product	2014-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205488-001	8877230	2024-02-04	U-1616		2014-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205488-001	11090312	2034-03-17	U-1616		2021-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205488-001	8574622	2024-02-04		Drug product	2014-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205488-001	8784869	2024-02-04		Drug product	2014-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205488-001	8784882	2024-02-04	U-1557	Drug product	2014-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205488-001	8877230	2024-02-04	U-1616		2014-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205488-001	11090312	2034-03-17	U-1616		2021-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205488-001	8574622	2024-02-04		Drug product	2014-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205488-001	8784869	2024-02-04		Drug product	2014-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205488-001	8784882	2024-02-04	U-1557	Drug product	2014-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205488-001	8877230	2024-02-04	U-1616		2014-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205488-001	11090312	2034-03-17	U-1616		2021-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205488-001	8574622	2024-02-04		Drug product	2014-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205488-001	8784869	2024-02-04		Drug product	2014-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205488-001	8784882	2024-02-04	U-1557	Drug product	2014-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205488-001	8877230	2024-02-04	U-1616		2014-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205488-001	11090312	2034-03-17	U-1616		2021-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205488-001	8574622	2024-02-04		Drug product	2014-06-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205488-001	8784869	2024-02-04		Drug product	2014-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205488-001	8784882	2024-02-04	U-1557	Drug product	2014-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205488-001	8877230	2024-02-04	U-1616		2014-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205488-001	11090312	2034-03-17	U-1616		2021-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205488-001	8574622	2024-02-04		Drug product	2014-06-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205488-001	8784869	2024-02-04		Drug product	2014-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205488-001	8784882	2024-02-04	U-1557	Drug product	2014-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205488-001	8877230	2024-02-04	U-1616		2014-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205488-001	11090312	2034-03-17	U-1616		2021-09-10	`79d66fd596c7…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2db4fc38-a116-b0ab-3dae-57df54e5f212	Product name	2	20250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3	Product name	5	20240422
7d55b53c-798b-47ae-992b-3921493a8303	Product name	1	20230322
8d753fd6-75b2-4f12-bcbf-339392960afa	Product name	1	20230303
4fbda828-a5be-46fe-83ec-a88da4359919	Product name	1	20230104
93cc9bee-8bdc-273d-ec7f-c2c52535317a	Product name	7	20210902
a6389cd1-36d1-4b5c-9934-1139bee93605	Product name	5	20210601
f4f0889f-ee8b-471f-9a37-02a035280637	Product name	1	20200122
09e1afd3-f431-4380-82c5-438884c25615	Product name	1	20190111
a6389cd1-36d1-4b5c-9934-1139bee93605	Product name	3	20171212
502efed8-01a5-ef6a-61c6-fe8302b6e26b	Product name	2	20171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2	Product name	1	20171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68	Product name	2	20171113
96bdf4b3-71cd-433d-9723-89e50f852992	Product name	1	20150810
ed2e617f-f28a-1df1-f9fc-c79702f31271	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69654-239-01	2021-01-29	C162847	48780-1	ba0f9c33-5438-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use NATESTO safely and effectively. See full prescribing information for NATESTO. Natesto (testosterone) nasal gel CIII Initial U.S. Approval: 1953

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69654-239-01	Natesto	1 in 1 CARTON	GEL	1		2
69654-239-01	Natesto	60 in 1 BOTTLE, PUMP	GEL	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69654-239-01	GM - Gram	69654-239	19a5fa43-fac8-4e1f-9a6f-f5e726c6adba	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69654-239	NATESTO (TESTOSTERONE) GEL [AYTU BIOSCIENCE, INC.]	2	Legacy NDC, 2 package rows	20191220_68d0447b-f75a-4fb2-96ba-de822b74aebb.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Natesto nasal gel	TESTOSTERONE	Acerus Pharmaceuticals Corporation	dea6bed1-eaca-11e3-ac10-0800200c9a66	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205488 application number: NDA205488

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3XMK78S47O	TESTOSTERONE	58-22-0	TESTOSTERONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1596782	Natesto 5.5 MG/ACTUAT Nasal Gel, 60 ACTUAT	PSN	68d0447b-f75a-4fb2-96ba-de822b74aebb	2
1596784	testosterone 5.5 MG/ACTUAT Nasal Gel, 60 ACTUAT	PSN	68d0447b-f75a-4fb2-96ba-de822b74aebb	2
1596782	60 ACTUAT testosterone 5.5 MG/ACTUAT Nasal Gel [Natesto]	SBD	68d0447b-f75a-4fb2-96ba-de822b74aebb	2
1596784	60 ACTUAT testosterone 5.5 MG/ACTUAT Nasal Gel	SCD	68d0447b-f75a-4fb2-96ba-de822b74aebb	2
1596782	Natesto 5.5 MG/ACTUAT Nasal Gel, 60 ACTUAT	SY	68d0447b-f75a-4fb2-96ba-de822b74aebb	2
1596784	testosterone 5.5 MG/ACTUAT Nasal Gel, 60 ACTUAT	SY	68d0447b-f75a-4fb2-96ba-de822b74aebb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69654-239-01	69654023901	1 in 1 CARTON	Historical