Delsym

Product NDC: 70518-1912
Requested package NDC: 70518-1912-0
11-digit product format: 705181912
Labeler code: 70518
Product ID: 70518-1912_be604cf7-92d9-5b65-e053-2995a90a3ece
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan
Dosage form: SUSPENSION, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA018658
Marketing category: NDA
Marketing start: 2019-03-04
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN
Active strength: 30 mg/5mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-1912	70518-1912-0	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018658-001	DELSYM	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	1982-10-08	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-1912-0	2023-03-07	C162847	48780-1	f386c64a-3454-0266-e053-dadaa90a7c1a	Delsym 12 Hour Cough Relief Grape
70518-1912-0	2023-01-30	C162847	48780-1	f386c64a-3454-0266-e053-dadaa90a7c1a	Delsym 12 Hour Cough Relief Grape

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	e3e1d126-76c2-4776-8ce0-449625b7e6ba	2026-09-09	Warnings	Exact identifier application applno (NDA): 018658 application number: NDA018658
Delsym	DEXTROMETHORPHAN	Reckitt Benckiser LLC	234e6a2c-a280-4a39-8777-9316e9d681fb	2026-05-27	Warnings	Exact identifier application applno (NDA): 018658 application number: NDA018658
Delsym (Dextromethorphan)	DEXTROMETHORPHAN	Reckitt Benckiser LLC	bb0116d0-93e4-44e2-b0e4-c0b773eced6f	2026-05-20	Warnings	Exact identifier application applno (NDA): 018658 application number: NDA018658
Delsym (Dextromethorphan)	DEXTROMETHORPHAN	Reckitt Benckiser LLC	ce4b477c-430e-40a3-b247-b3914ef17793	2026-05-13	Warnings	Exact identifier application applno (NDA): 018658 application number: NDA018658
DELSYM	DEXTROMETHORPHAN	A-S Medication Solutions	2ac3cac7-5980-4ff5-9939-d494c3daa9d2	2025-02-28	Warnings	Exact identifier application applno (NDA): 018658 application number: NDA018658

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7355X3ROTS	DEXTROMETHORPHAN	125-71-3	DEXTROMETHORPHAN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-1912-0	70518191200	1 BOTTLE in 1 CARTON (70518-1912-0) > 89 mL in 1 BOTTLE	1 bottle	2019-03-04	0000-00-00	No	No	Current