Application 018658

Type: NDA
Sponsor: RB HLTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DELSYM	DEXTROMETHORPHAN POLISTIREX	SUSPENSION, EXTENDED RELEASE;ORAL	EQ 30MG HYDROBROMIDE/5ML	Yes	Yes

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

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
N018658-001	DELSYM	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	1982-10-08

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`cb3db0bc1861…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Delsym	DEXTROMETHORPHAN	Reckitt Benckiser LLC	234e6a2c-a280-4a39-8777-9316e9d681fb	2026-05-27	Warnings	Exact identifier application applno (NDA): 018658 application number: NDA018658 ndc (product): 63824-171
Delsym	DEXTROMETHORPHAN	Reckitt Benckiser LLC	e3e1d126-76c2-4776-8ce0-449625b7e6ba	2026-05-27	Warnings	Exact identifier application applno (NDA): 018658 application number: NDA018658 ndc (product): 63824-175
Delsym (Dextromethorphan)	DEXTROMETHORPHAN	Reckitt Benckiser LLC	bb0116d0-93e4-44e2-b0e4-c0b773eced6f	2026-05-20	Warnings	Exact identifier application applno (NDA): 018658 application number: NDA018658 ndc (product): 63824-173
Delsym (Dextromethorphan)	DEXTROMETHORPHAN	Reckitt Benckiser LLC	ce4b477c-430e-40a3-b247-b3914ef17793	2026-05-13	Warnings	Exact identifier application applno (NDA): 018658 application number: NDA018658 ndc (product): 63824-177
DELSYM	DEXTROMETHORPHAN	A-S Medication Solutions	2ac3cac7-5980-4ff5-9939-d494c3daa9d2	2025-02-28	Warnings	Exact identifier application applno (NDA): 018658 application number: NDA018658 ndc (product): 50090-0224

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0172	Delsym	Dextromethorphan	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-0172	Delsym	Dextromethorphan	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-0172	Delsym	Dextromethorphan	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-0172	Delsym	Dextromethorphan	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-0276	Delsym (Dextromethorphan)	Dextromethorphan	Atlantic Biologicals Corps	NDA	Current
21695-517	Delsym	Dextromethorphan Polistirex	Rebel Distributors Corp	NDA	Current
21695-518	Delsym	Dextromethorphan Polistirex	Rebel Distributors Corp	NDA	Current
50090-0224	Delsym	Dextromethorphan	A-S Medication Solutions	NDA	Current
50090-0224	Delsym	Dextromethorphan	A-S Medication Solutions	NDA	Current
50090-0224	Delsym	Dextromethorphan	A-S Medication Solutions	NDA	Current
50090-0224	Delsym	Dextromethorphan	A-S Medication Solutions	NDA	Current
50090-0224	Delsym	Dextromethorphan	A-S Medication Solutions	NDA	Current
63824-171	Delsym	Dextromethorphan	RB Health (US) LLC	NDA	Current
63824-171	Delsym	Dextromethorphan	Reckitt Benckiser LLC	NDA	Current
63824-171	Delsym	Dextromethorphan	RB Health (US) LLC	NDA	Current
63824-172	Delsym	Dextromethorphan	Reckitt Benckiser LLC	NDA	Current
63824-173	Delsym (Dextromethorphan)	Dextromethorphan	RB Health (US) LLC	NDA	Current
63824-173	Delsym (Dextromethorphan)	Dextromethorphan	Reckitt Benckiser LLC	NDA	Current
63824-173	Delsym (Dextromethorphan)	Dextromethorphan	RB Health (US) LLC	NDA	Current
63824-175	Delsym	Dextromethorphan	RB Health (US) LLC	NDA	Current
63824-175	Delsym	Dextromethorphan	RB Health (US) LLC	NDA	Current
63824-175	Delsym	Dextromethorphan	Reckitt Benckiser LLC	NDA	Current
63824-176	Delsym	Dextromethorphan	Reckitt Benckiser LLC	NDA	Current
63824-177	Delsym (Dextromethorphan)	Dextromethorphan	RB Health (US) LLC	NDA	Current
63824-177	Delsym (Dextromethorphan)	Dextromethorphan	RB Health (US) LLC	NDA	Current
63824-177	Delsym (Dextromethorphan)	Dextromethorphan	Reckitt Benckiser LLC	NDA	Current
70518-1912	Delsym	Dextromethorphan	REMEDYREPACK INC.	NDA	Current
70518-1912	Delsym	Dextromethorphan	REMEDYREPACK INC.	NDA	Current
70518-1912	Delsym	Dextromethorphan	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77867	SUPPL	2024-03-19
77855	SUPPL	2024-03-18
64275	SUPPL	2020-08-13
15077	SUPPL	2014-08-11
11266	SUPPL	2014-08-05
1005	SUPPL	2011-05-19
1004	SUPPL	2010-11-15
15076	SUPPL	2010-04-13
15075	SUPPL	2009-11-12
15074	SUPPL	2008-12-10
33543	SUPPL	2007-10-04
1003	SUPPL	2007-10-04
40816	SUPPL	2007-04-09
1002	SUPPL	2005-03-10
1001	SUPPL	2004-11-16
15073	SUPPL	2002-01-24