DEXTROMETHORPHAN HYDROBROMIDE

Product NDC: 68210-1530
11-digit product format: 682101530
Labeler code: 68210
Product ID: 68210-1530_9e5110a5-04b0-4442-b095-d45e04c2266a
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN HYDROBROMIDE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: SPIRIT PHARMACEUTICALS,LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-07-15
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 15 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68210-1530		I	Inactivated by FDA	2026-10-16
excluded package	package	68210-1530	68210-1530-1	I	Inactivated by FDA	2026-10-16
excluded package	package	68210-1530	68210-1530-4	I	Inactivated by FDA	2026-10-16
excluded package	package	68210-1530	68210-1530-6	I	Inactivated by FDA	2026-10-16
excluded package	package	68210-1530	68210-1530-8	I	Inactivated by FDA	2026-10-16

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 2 · 110 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-1530-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-1530-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-1530-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-1530-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-1530-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-1530-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-1530-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-1530-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-1530-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-1530-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-1530-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-1530-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-1530-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-1530-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-1530-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-1530-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-1530-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-1530-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-1530-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-1530-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-1530-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-1530-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-1530-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-1530-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-1530-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-1530-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-1530-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-1530-6	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-1530-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-1530-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-1530-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-1530-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-1530-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-1530-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-1530-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-1530-6	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-1530-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-1530-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-1530-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-1530-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68210-1530-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68210-1530-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68210-1530-8	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68210-1530-6	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68210-1530-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68210-1530-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68210-1530-8	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68210-1530-6	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
68210-1530-1	Dextrmethorphan Hydrobromide Soft Gelatin Capsules
68210-1530-4	Dextrmethorphan Hydrobromide Soft Gelatin Capsules
68210-1530-6	Dextrmethorphan Hydrobromide Soft Gelatin Capsules
68210-1530-8	Dextrmethorphan Hydrobromide Soft Gelatin Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68210-1530-1	DEXTROMETHORPHAN HYDROBROMIDE	1 in 1 DRUM	CAPSULE, LIQUID FILLED	1	2
68210-1530-1	DEXTROMETHORPHAN HYDROBROMIDE	10000 in 1 BAG	CAPSULE, LIQUID FILLED	10000	2
68210-1530-4	DEXTROMETHORPHAN HYDROBROMIDE	4000 in 1 BAG	CAPSULE, LIQUID FILLED	4000	2
68210-1530-4	DEXTROMETHORPHAN HYDROBROMIDE	1 in 1 DRUM	CAPSULE, LIQUID FILLED	1	2
68210-1530-6	DEXTROMETHORPHAN HYDROBROMIDE	6000 in 1 BAG	CAPSULE, LIQUID FILLED	6000	2
68210-1530-6	DEXTROMETHORPHAN HYDROBROMIDE	1 in 1 DRUM	CAPSULE, LIQUID FILLED	1	2
68210-1530-8	DEXTROMETHORPHAN HYDROBROMIDE	1 in 1 DRUM	CAPSULE, LIQUID FILLED	1	2
68210-1530-8	DEXTROMETHORPHAN HYDROBROMIDE	8000 in 1 BAG	CAPSULE, LIQUID FILLED	8000	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-1530	DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]	2	Legacy NDC, 8 package rows	20100810_3e52987b-47d5-4023-8d96-af7cf7fc25b9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1090487	dextromethorphan HBr 15 MG Oral Capsule	PSN	3e52987b-47d5-4023-8d96-af7cf7fc25b9	2
1090487	dextromethorphan hydrobromide 15 MG Oral Capsule	SCD	3e52987b-47d5-4023-8d96-af7cf7fc25b9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68210-1530-1	68210153001	1 in 1 DRUM	Historical
68210-1530-4	68210153004	4000 in 1 BAG	Historical
68210-1530-6	68210153006	6000 in 1 BAG	Historical
68210-1530-8	68210153008	1 in 1 DRUM	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dextrmethorphan Hydrobromide Soft Gelatin Capsules	SPIRIT PHARMACEUTICALS,LLC	2010-07-26	HUMAN OTC DRUG LABEL	2