Valtoco

Product NDC: 72252-515
Requested package NDC: 72252-515-04
11-digit product format: 722520515
Labeler code: 72252
Product ID: 72252-515_6642d0cb-3186-4b4c-8a67-c3f92081fbd0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diazepam
Dosage form: SPRAY
Route: NASAL
Labeler: Neurelis, Inc
Application: NDA211635
Marketing category: NDA
Marketing start: 2020-01-10
Substance: DIAZEPAM
Active strength: 7.5 mg/.1mL
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N211635-001	VALTOCO	DIAZEPAM	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10
N211635-002	VALTOCO	DIAZEPAM	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10
N211635-003	VALTOCO	DIAZEPAM	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211635-001	11241414	2029-03-27		Drug product	2022-03-01
N211635-001	11793786	2029-03-27		Drug product	2023-10-31
N211635-001	12268664	2029-03-27		Drug product	2025-04-09
N211635-001	12521400	2029-03-27		Drug product	2026-01-15
N211635-001	8895546	2029-03-27		Drug product	2020-02-06
N211635-001	12337061	2032-06-13	U-4173		2025-06-27
N211635-001	12324852	2032-10-16	U-4173		2025-06-27
N211635-001	12599611	2042-06-10	U-4455		2026-04-20
N211635-002	11241414	2029-03-27		Drug product	2022-03-01
N211635-002	11793786	2029-03-27		Drug product	2023-10-31
N211635-002	12268664	2029-03-27		Drug product	2025-04-09
N211635-002	12521400	2029-03-27		Drug product	2026-01-15
N211635-002	8895546	2029-03-27		Drug product	2020-02-06
N211635-002	12337061	2032-06-13	U-4173		2025-06-27
N211635-002	12324852	2032-10-16	U-4173		2025-06-27
N211635-002	12599611	2042-06-10	U-4455		2026-04-20
N211635-003	11241414	2029-03-27		Drug product	2022-03-01
N211635-003	11793786	2029-03-27		Drug product	2023-10-31
N211635-003	12268664	2029-03-27		Drug product	2025-04-09
N211635-003	12521400	2029-03-27		Drug product	2026-01-15
N211635-003	8895546	2029-03-27		Drug product	2020-02-06
N211635-003	12337061	2032-06-13	U-4173		2025-06-27
N211635-003	12324852	2032-10-16	U-4173		2025-06-27
N211635-003	12599611	2042-06-10	U-4455		2026-04-20

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211635-001	ODE-279	2027-01-10
N211635-001	NPP	2028-04-15
N211635-002	ODE-279	2027-01-10
N211635-002	NPP	2028-04-15
N211635-003	ODE-279	2027-01-10
N211635-003	NPP	2028-04-15

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 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 684 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211635-001	11241414	2029-03-27		Drug product	2022-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	11793786	2029-03-27		Drug product	2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	12268664	2029-03-27		Drug product	2025-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	12521400	2029-03-27		Drug product	2026-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	8895546	2029-03-27		Drug product	2020-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	12337061	2032-06-13	U-4173		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	12324852	2032-10-16	U-4173		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	12599611	2042-06-10	U-4455		2026-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	11241414	2029-03-27		Drug product	2022-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	11793786	2029-03-27		Drug product	2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	12268664	2029-03-27		Drug product	2025-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	12521400	2029-03-27		Drug product	2026-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	8895546	2029-03-27		Drug product	2020-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	12337061	2032-06-13	U-4173		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	12324852	2032-10-16	U-4173		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	12599611	2042-06-10	U-4455		2026-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	11241414	2029-03-27		Drug product	2022-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	11793786	2029-03-27		Drug product	2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	12268664	2029-03-27		Drug product	2025-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	12521400	2029-03-27		Drug product	2026-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	8895546	2029-03-27		Drug product	2020-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	12337061	2032-06-13	U-4173		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	12324852	2032-10-16	U-4173		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	12599611	2042-06-10	U-4455		2026-04-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211635-001	11241414	2029-03-27		Drug product	2022-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	11793786	2029-03-27		Drug product	2023-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	12268664	2029-03-27		Drug product	2025-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	12521400	2029-03-27		Drug product	2026-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	8895546	2029-03-27		Drug product	2020-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	12337061	2032-06-13	U-4173		2025-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	12324852	2032-10-16	U-4173		2025-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	12599611	2042-06-10	U-4455		2026-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	11241414	2029-03-27		Drug product	2022-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	11793786	2029-03-27		Drug product	2023-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	12268664	2029-03-27		Drug product	2025-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	12521400	2029-03-27		Drug product	2026-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	8895546	2029-03-27		Drug product	2020-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	12337061	2032-06-13	U-4173		2025-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	12324852	2032-10-16	U-4173		2025-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	12599611	2042-06-10	U-4455		2026-04-20	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 195 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N211635-001	ODE-279	2027-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	NPP	2028-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	ODE-279	2027-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	NPP	2028-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	ODE-279	2027-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	NPP	2028-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211635-001	ODE-279	2027-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	NPP	2028-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	ODE-279	2027-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	NPP	2028-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-003	ODE-279	2027-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-003	NPP	2028-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211635-001	ODE-279	2027-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211635-001	NPP	2028-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211635-002	ODE-279	2027-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211635-002	NPP	2028-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211635-003	ODE-279	2027-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211635-003	NPP	2028-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211635-001	ODE-279	2027-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211635-001	NPP	2028-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211635-002	ODE-279	2027-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211635-002	NPP	2028-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211635-003	ODE-279	2027-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211635-003	NPP	2028-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211635-001	ODE-279	2027-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211635-001	NPP	2028-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211635-002	ODE-279	2027-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211635-002	NPP	2028-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211635-003	ODE-279	2027-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211635-003	NPP	2028-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211635-001	ODE-279	2027-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211635-002	ODE-279	2027-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211635-003	ODE-279	2027-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211635-001	ODE-279	2027-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211635-002	ODE-279	2027-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211635-003	ODE-279	2027-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211635-001	ODE-279	2027-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211635-002	ODE-279	2027-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211635-003	ODE-279	2027-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211635-001	ODE-279	2027-01-10	`2680178bc6a6…`

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: Valtoco
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIAZEPAM	7.5 mg/.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q3JTX2Q7TU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2272613	Internal RxNorm lookup
2272619	Internal RxNorm lookup
2272621	Internal RxNorm lookup
2272622	Internal RxNorm lookup
2272623	Internal RxNorm lookup
2272624	Internal RxNorm lookup
2272626	Internal RxNorm lookup
2272627	Internal RxNorm lookup
2272629	Internal RxNorm lookup
2272630	Internal RxNorm lookup
2272632	Internal RxNorm lookup
2272633	Internal RxNorm lookup
2272635	Internal RxNorm lookup
2272636	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
1a8bcc90-68fa-474d-832c-0df01e825f39	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
69057c52-36b0-21c0-02d6-d697be15c03c	Product name	4	20260305
da74e203-d183-4c62-8511-c3ef56b5964e	Product name	1	20250213
2792dd44-ff30-4712-8b05-1850c2b4d307	Product name	3	20250211
2fd3ebb9-86c1-64e3-e9b6-3c2ba01c6876	Product name	2	20250102
0f898f8b-23f1-b816-6bfe-c7f8aac7e42b	Product name	2	20240529
2c487d7e-cbfc-4699-9c83-5c1c7521cde9	Product name	1	20200610
02ac201d-7ee6-00c9-f963-81bb5a506b68	Product name	3	20160816

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-08-17	These highlights do not include all the information needed to use VALTOCO nasal spray safely and effectively. See full prescribing information for VALTOCO nasal spray. VALTOCO ® (diazepam nasal spray), CIV Initial U.S. Approval: 1963
2023-08-17	These highlights do not include all the information needed to use VALTOCO nasal spray safely and effectively. See full prescribing information for VALTOCO nasal spray. VALTOCO ® (diazepam nasal spray), CIV Initial U.S. Approval: 1963
2023-07-28	These highlights do not include all the information needed to use VALTOCO nasal spray safely and effectively. See full prescribing information for VALTOCO nasal spray. VALTOCO ® (diazepam nasal spray), CIV Initial U.S. Approval: 1963
2023-07-28	These highlights do not include all the information needed to use VALTOCO nasal spray safely and effectively. See full prescribing information for VALTOCO nasal spray. VALTOCO ® (diazepam nasal spray), CIV Initial U.S. Approval: 1963

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72252-515-04	Valtoco	2 in 1 CARTON	SPRAY	2	14
72252-515-04	Valtoco	2 in 1 BLISTER PACK	SPRAY	2	14
72252-515-10	Valtoco	2 in 1 BLISTER PACK	SPRAY	2	14
72252-515-10	Valtoco	5 in 1 CARTON	SPRAY	5	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72252-515-04	EA - Each	72252-515	5abf7c14-87b2-42d2-bf15-3982c7ea0369	1	2020-02-13
72252-515-10	EA - Each	72252-515	45de7b05-0ccf-46e7-9dce-491bd5dcae42	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72252-515	VALTOCO (DIAZEPAM) SPRAY [NEURELIS, INC]	11	Current NDC, Legacy NDC, 4 package rows	20250508_1a8bcc90-68fa-474d-832c-0df01e825f39.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
Valtoco	DIAZEPAM	Neurelis, Inc	1a8bcc90-68fa-474d-832c-0df01e825f39	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211635 application number: NDA211635 ndc (package): 72252-515-04 ndc (product): 72252-515 ndc11 (package): 72252051504

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q3JTX2Q7TU	DIAZEPAM	439-14-5	DIAZEPAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2272622	{1 (0.1 ML) (diazepam 100 MG/ML Nasal Spray [Valtoco]) } Pack [Valtoco 10 MG Dose Kit]	BPCK	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272630	{1 (0.1 ML) (diazepam 50 MG/ML Nasal Spray [Valtoco]) } Pack [Valtoco 5 MG Dose Kit]	BPCK	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272624	{2 (0.1 ML) (diazepam 100 MG/ML Nasal Spray [Valtoco]) } Pack [Valtoco 20 MG Dose Kit]	BPCK	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272636	{2 (0.1 ML) (diazepam 75 MG/ML Nasal Spray [Valtoco]) } Pack [Valtoco 15 MG Dose Kit]	BPCK	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272621	{1 (0.1 ML) (diazepam 100 MG/ML Nasal Spray) } Pack	GPCK	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272627	{1 (0.1 ML) (diazepam 50 MG/ML Nasal Spray) } Pack	GPCK	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272623	{2 (0.1 ML) (diazepam 100 MG/ML Nasal Spray) } Pack	GPCK	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272633	{2 (0.1 ML) (diazepam 75 MG/ML Nasal Spray) } Pack	GPCK	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272613	diazePAM 10 MG in 0.1 mL Nasal Spray	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272621	diazePAM 10 MG in 0.1 mL Nasal Spray Dose Kit	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272633	diazePAM 15 MG (2 X 7.5 MG in 0.1 mL) Nasal Spray Dose Kit	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272623	diazePAM 20 MG (2 X 10 MG in 0.1 mL) Nasal Spray Dose Kit	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272626	diazePAM 5 MG in 0.1 mL Nasal Spray	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272627	diazePAM 5 MG in 0.1 mL Nasal Spray Dose Kit	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272632	diazePAM 7.5 MG in 0.1 mL Nasal Spray	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272622	VALTOCO 10 MG Dose Kit	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272619	VALTOCO 10 MG in 0.1 mL Nasal Spray	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272636	VALTOCO 15 MG Dose Kit	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272624	VALTOCO 20 MG Dose Kit	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272630	VALTOCO 5 MG Dose Kit	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272629	Valtoco 5 MG per 0.1 mL Nasal Spray	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272635	Valtoco 7.5 MG in 0.1 mL Nasal Spray	PSN	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272619	diazepam 100 MG/ML Nasal Spray [Valtoco]	SBD	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272629	diazepam 50 MG/ML Nasal Spray [Valtoco]	SBD	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272635	diazepam 75 MG/ML Nasal Spray [Valtoco]	SBD	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272613	diazepam 100 MG/ML Nasal Spray	SCD	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272626	diazepam 50 MG/ML Nasal Spray	SCD	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272632	diazepam 75 MG/ML Nasal Spray	SCD	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272613	diazepam 10 MG per 0.1 mL Nasal Spray	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272621	diazepam 10 MG per 0.1 mL Nasal Spray Dose Kit	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272633	diazepam 15 MG (2 X 7.5 MG per 0.1 mL) Nasal Spray Dose Kit	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272623	diazepam 20 MG (2 X 10 MG per 0.1 mL) Nasal Spray Dose Kit	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272626	diazepam 5 MG in 0.1 mL Nasal Spray	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272627	diazepam 5 MG per 0.1 mL Nasal Spray Dose Kit	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272632	diazepam 7.5 MG per 0.1 mL Nasal Spray	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272622	VALTOCO 10 MG Dose Kit	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272619	Valtoco 10 MG per 0.1 mL Nasal Spray	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272619	Valtoco 100 MG/ML Nasal Spray	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272636	VALTOCO 15 MG Dose Kit	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272624	VALTOCO 20 MG Dose Kit	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272630	VALTOCO 5 MG Dose Kit	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272629	Valtoco 5 MG per 0.1 ML Nasal Spray	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272629	Valtoco 50 MG/ML Nasal Spray	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272635	Valtoco 7.5 MG per 0.1 ML Nasal Spray	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14
2272635	Valtoco 75 MG/ML Nasal Spray	SY	1a8bcc90-68fa-474d-832c-0df01e825f39	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72252-515-04	72252051504	2 BLISTER PACK in 1 CARTON (72252-515-04) / 2 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE	2 blister pack	2020-01-10	0000-00-00	No	No	Current