Delsym

Product NDC: 63824-176
11-digit product format: 638240176
Labeler code: 63824
Product ID: 63824-176_110056a6-a283-47b3-9fc3-c37b92b505de
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan
Dosage form: SUSPENSION, EXTENDED RELEASE
Route: ORAL
Labeler: Reckitt Benckiser LLC
Application: NDA018658
Marketing category: NDA
Marketing start: 2010-05-04
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN
Active strength: 30 mg/5mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63824-176		D	Discontinued by firm	2026-08-11
excluded package	package	63824-176	63824-176-63	D	Discontinued by firm	2026-08-11
excluded package	package	63824-176	63824-176-65	D	Discontinued by firm	2026-08-11

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 · 54 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63824-176-65	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63824-176-63	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63824-176-65	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63824-176-63	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63824-176-65	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63824-176-63	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63824-176-65	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63824-176-63	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63824-176-65	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63824-176-63	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63824-176-65	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63824-176-63	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63824-176-65	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63824-176-63	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63824-176-65	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63824-176-63	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63824-176-65	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63824-176-63	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63824-176-65	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63824-176-63	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63824-176-65	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63824-176-63	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63824-176-65	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63824-176-63	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63824-176-65	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63824-176-63	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63824-176-65	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63824-176-63	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63824-176-65	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63824-176-63	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63824-176-65	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63824-176-63	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63824-176-65	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63824-176-63	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63824-176-65	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63824-176-63	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63824-176-63	2023-08-24	Delsym 12 Hour Cough Relief Orange for Children & Adults
63824-176-65	2023-08-24	Delsym 12 Hour Cough Relief Orange for Children & Adults
63824-176-63	2020-01-31	Delsym 12 Hour Cough Relief Orange for Children & Adults
63824-176-65	2020-01-31	Delsym 12 Hour Cough Relief Orange for Children & Adults

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-176-63	ML - Milliliter	63824-176	eef2e1fd-3d44-4a2b-862b-adfe4364f00f	1	2012-07-24
63824-176-65	ML - Milliliter	63824-176	b6939823-f101-41a6-b0fa-df9228431762	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dextromethorphan	ACTIVE INGREDIENT	7355X3ROTS	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
high fructose corn syrup	INACTIVE INGREDIENT	XY6UN3QB6S	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
Polistirex	INACTIVE INGREDIENT	5H9W9GTW27	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
sucrose	INACTIVE INGREDIENT	C151H8M554	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
tragacanth	INACTIVE INGREDIENT	2944357O2O	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
water	INACTIVE INGREDIENT	059QF0KO0R	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	4

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
Delsym	DEXTROMETHORPHAN	Reckitt Benckiser LLC	e3e1d126-76c2-4776-8ce0-449625b7e6ba	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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Delsym 12 Hour Cough Relief Orange for Children & Adults	Reckitt Benckiser LLC	2014-06-20	HUMAN OTC DRUG LABEL	4