Night Time Gelcap

Product NDC: 67510-0521
11-digit product format: 675100521
Labeler code: 67510
Product ID: 67510-0521_9ea99d30-2c01-4899-8557-55ff3710818d
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan, Doxylamine
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Kareway Product, Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-06-01
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 325 mg/1; mg/1; mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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	67510-0521		I	Inactivated by FDA	2026-10-20
excluded package	package	67510-0521	67510-0521-0	I	Inactivated by FDA	2026-10-20
excluded package	package	67510-0521	67510-0521-1	I	Inactivated by FDA	2026-10-20
excluded package	package	67510-0521	67510-0521-2	I	Inactivated by FDA	2026-10-20
excluded package	package	67510-0521	67510-0521-4	I	Inactivated by FDA	2026-10-20

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	67510-0521-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67510-0521-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67510-0521-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67510-0521-1	`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	67510-0521-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67510-0521-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67510-0521-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67510-0521-1	`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	67510-0521-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67510-0521-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67510-0521-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67510-0521-1	`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	67510-0521-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67510-0521-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67510-0521-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67510-0521-1	`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	67510-0521-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67510-0521-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67510-0521-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67510-0521-1	`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	67510-0521-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67510-0521-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67510-0521-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67510-0521-1	`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	67510-0521-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67510-0521-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67510-0521-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67510-0521-1	`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	67510-0521-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67510-0521-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67510-0521-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67510-0521-1	`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	67510-0521-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67510-0521-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67510-0521-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67510-0521-1	`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	67510-0521-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67510-0521-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67510-0521-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67510-0521-1	`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	67510-0521-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67510-0521-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67510-0521-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67510-0521-1	`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	67510-0521-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67510-0521-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67510-0521-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67510-0521-1	`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
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67510-0521-0	Drug Facts
67510-0521-1	Drug Facts
67510-0521-2	Drug Facts
67510-0521-4	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67510-0521-0	Night Time Gelcap	2 in 1 BOX	CAPSULE, LIQUID FILLED	2	2
67510-0521-0	Night Time Gelcap	20 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	20	2
67510-0521-1	Night Time Gelcap	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	2
67510-0521-1	Night Time Gelcap	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	2
67510-0521-2	Night Time Gelcap	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	2
67510-0521-2	Night Time Gelcap	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12	2
67510-0521-4	Night Time Gelcap	24 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	24	2
67510-0521-4	Night Time Gelcap	2 in 1 BOX	CAPSULE, LIQUID FILLED	2	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
PROPYLENE GLYCOL, (R)-	INACTIVE INGREDIENT	602HN5L69H	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67510-0521	NIGHT TIME GELCAP (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE) CAPSULE, LIQUID FILLED [KAREWAY PRODUCT, INC.]	2	Legacy NDC, 8 package rows	20130104_6b9b3de7-58cc-4b15-8e6e-6751ef40bc55.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1112865	acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 5 MG Oral Capsule	PSN	6b9b3de7-58cc-4b15-8e6e-6751ef40bc55	2
1112865	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 5 MG Oral Capsule	SCD	6b9b3de7-58cc-4b15-8e6e-6751ef40bc55	2
1112865	APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 5 MG Oral Capsule	SY	6b9b3de7-58cc-4b15-8e6e-6751ef40bc55	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67510-0521-0	67510052100	2 in 1 BOX	Historical
67510-0521-1	67510052101	1 in 1 BOX	Historical
67510-0521-2	67510052102	1 in 1 BOX	Historical
67510-0521-4	67510052104	24 in 1 BLISTER PACK	Historical