Delsym (Dextromethorphan)

Product NDC: 63824-177
Requested package NDC: 63824-177-65
11-digit product format: 638240177
Labeler code: 63824
Product ID: 63824-177_51b62d53-491c-8ba5-e063-6394a90a1821
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: 2011-08-19
Substance: DEXTROMETHORPHAN
Active strength: 30 mg/5mL
Pharmacologic classes: Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	63824-177	63824-177-65	D	Discontinued by firm		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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
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 · 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	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…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Delsym (Dextromethorphan)
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN	30 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7355X3ROTS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1373045	Internal RxNorm lookup
1373128	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
ce4b477c-430e-40a3-b247-b3914ef17793	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63824-177-63	2022-06-21	Delsym ® (Dextromethorphan) Suspension Extended-Release
63824-177-65	2022-06-21	Delsym ® (Dextromethorphan) Suspension Extended-Release
63824-177-63	2022-01-28	Delsym ® (Dextromethorphan) Suspension Extended-Release
63824-177-65	2022-01-28	Delsym ® (Dextromethorphan) Suspension Extended-Release

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63824-177-63	Delsym (Dextromethorphan)	89 mL in 1 BOTTLE	SUSPENSION, EXTENDED RELEASE	89	8
63824-177-63	Delsym (Dextromethorphan)	1 in 1 CARTON	SUSPENSION, EXTENDED RELEASE	1	8
63824-177-65	Delsym (Dextromethorphan)	148 mL in 1 BOTTLE	SUSPENSION, EXTENDED RELEASE	148	8
63824-177-65	Delsym (Dextromethorphan)	1 in 1 CARTON	SUSPENSION, EXTENDED RELEASE	1	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-177-63	ML - Milliliter	63824-177	89c18b57-1a96-4537-a71a-61fad394a8d5	1	2015-10-02
63824-177-65	ML - Milliliter	63824-177	72949293-23a2-477c-ba6b-9e5568dcf5cf	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dextromethorphan	ACTIVE INGREDIENT	7355X3ROTS	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
high fructose corn syrup	INACTIVE INGREDIENT	XY6UN3QB6S	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
Polistirex	INACTIVE INGREDIENT	5H9W9GTW27	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
tragacanth	INACTIVE INGREDIENT	2944357O2O	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RECKITT BENCKISER LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63824-177	DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [RB HEALTH (US) LLC]	7	Current NDC, Legacy NDC, 4 package rows	20240410_ce4b477c-430e-40a3-b247-b3914ef17793.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 · 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 ndc (package): 63824-177-65 ndc (product): 63824-177 ndc11 (package): 63824017765
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1373128	Delsym 30 MG in 5 mL 12HR Extended Release Oral Suspension	PSN	ce4b477c-430e-40a3-b247-b3914ef17793	8
1373045	dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension	PSN	ce4b477c-430e-40a3-b247-b3914ef17793	8
1373128	12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym]	SBD	ce4b477c-430e-40a3-b247-b3914ef17793	8
1373045	12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension	SCD	ce4b477c-430e-40a3-b247-b3914ef17793	8
1373128	Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release Suspension	SY	ce4b477c-430e-40a3-b247-b3914ef17793	8
1373045	dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension	SY	ce4b477c-430e-40a3-b247-b3914ef17793	8
1373045	dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension	SY	ce4b477c-430e-40a3-b247-b3914ef17793	8
1373128	Delsym 30 MG in 5 mL 12HR Extended Release Oral Suspension	PSN	56f5f9d1-54a6-48a5-8033-efc29e632479	2
1373045	dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension	PSN	56f5f9d1-54a6-48a5-8033-efc29e632479	2
1373128	12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym]	SBD	56f5f9d1-54a6-48a5-8033-efc29e632479	2
1373045	12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension	SCD	56f5f9d1-54a6-48a5-8033-efc29e632479	2
1373128	Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release Suspension	SY	56f5f9d1-54a6-48a5-8033-efc29e632479	2
1373045	dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension	SY	56f5f9d1-54a6-48a5-8033-efc29e632479	2
1373045	dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension	SY	56f5f9d1-54a6-48a5-8033-efc29e632479	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63824-177-65	63824017765	1 BOTTLE in 1 CARTON (63824-177-65) > 148 mL in 1 BOTTLE	1 bottle	2017-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Delsym ® (Dextromethorphan) Suspension Extended-Release	Reckitt Benckiser LLC	2026-05-13	HUMAN OTC DRUG LABEL	8
Delsym (Dextromethorphan) Suspension Extended-Release ®	Atlantic Biologicals Corps	2016-05-04	HUMAN OTC DRUG LABEL	2